Drugs
-
OGD Suitability Tracking Report (Sorted by Drug Name)
| Drug/Strength | Petition No/Firm | Dosage Form | Status | Status Date |
|---|---|---|---|---|
| ABACAVIR SULFATE 60 MG | 07P-0407/CP1 MATRIX LABORATORIES | TABLETS | Pending | 10/31/2007 |
| ACETAMINOPHEN 120 MG CODEINE PHOSPHATE 12 MG | 94P-0182/CP1 WE PHARMS | CHEWABLE TABLET | Withdrawn | 3/26/2007 |
| ACETAMINOPHEN 150 MG ASPIRIN 180 MG | 92P-0282/CP4 MIKART | CAPSULE OR TABLET | Withdrawn | 3/26/2007 |
| ACETAMINOPHEN 150 MG ASPIRIN 180 MG | 92P-0282/CP3 MIKART | CAPSULE OR TABLET | Withdrawn | 3/26/2007 |
| ACETAMINOPHEN 150 MG ASPIRIN 180 MG | 92P-0282/CP2 MIKART | CAPSULE OR TABLET | Withdrawn | 3/26/2007 |
| ACETAMINOPHEN 150 MG ASPIRIN 180 MG | 94P-0212/CP1 MIKART | TABLET | Withdrawn | 3/26/2007 |
| ACETAMINOPHEN 150 MG ASPIRIN 180 MG | 94P-0211/CP1 MIKART | TABLET | Withdrawn | 3/26/2007 |
| ACETAMINOPHEN 150 MG ASPIRIN 180 MG | 94P-0210/CP1 MIKART | TABLET | Withdrawn | 3/26/2007 |
| ACETAMINOPHEN 150 MG ASPIRIN 180 MG | 92P-0282/CP1 MIKART | CAPSULE OR TABLET | Withdrawn | 3/26/2007 |
| ACETAMINOPHEN 160 MG/5ML CODEINE PHOSPHATE 6 MG/5 ML | 87P-0323/CP KLEINFELD, KAPLAN & BECKER | SYRUP | Withdrawn | 3/26/2007 |
| ACETAMINOPHEN 200MG;200MG; 200MG HYDROCODONE BITARTRATE 5MG;7.5MG;10MG | 02P-0004/CP1 SHOTWELL AND CARR, INC. | TABLET; ORAL | Denied | 3/17/2003 |
| ACETAMINOPHEN 300 MG BUTALBITAL 50 MG | 04P-0561/CP1 LACHMAN CONSULTANT SERVICES | CAPSULES | Approved | 3/31/2005 |
| ACETAMINOPHEN 300 MG BUTALBITAL 50 MG | 04P-0560/CP1 LACHMAN CONSULTANT SERVICES | CAPSULES | Approved | 3/31/2005 |
| ACETAMINOPHEN 300 MG CODEINE PHOSPHATE 30 MG | 85P-0543/CP SOFTAN | SOFT GELATIN CAPSULE | Withdrawn | 3/26/2007 |
| ACETAMINOPHEN 312.5 MG PENTAZOCINE HCL 25 MG | 12P-0478 XSPIRE PHARMA | TABLETS | Pending | 5/24/2012 |
| ACETAMINOPHEN 312.5 mg CAFFEINE 60 mg | 12P-0775 XSPIRE PHARMA | TABLET | Pending | 7/26/2012 |
| ACETAMINOPHEN 320.5 MG CAFFEINE 30 MG | 11P-0728 WRASER PHARMACEUTICALS | CAPSULES | Approved | 7/7/2012 |
| ACETAMINOPHEN 325 MG BUTALBITAL 25 MG | 11P-0093 SOVEREIGN PHARMACEUTICALS | TABLETS | Approved | 4/18/2012 |
| ACETAMINOPHEN 325 MG ASPIRIN 325 MG | 86P-0361/CP BOCK PHARMA | TABLET | Withdrawn | 3/26/2007 |
| ACETAMINOPHEN 325 MG BUTALBITAL 50 MG | 93P-0346/CP1 MIKART | CAPSULE OR TABLET | Withdrawn | 3/26/2007 |
| ACETAMINOPHEN 325 MG CAFFEINE 30 MG | 11P-0096 SOVEREIGN PHARMACEUTICALS | TABLETS | Approved | 9/27/2012 |
| ACETAMINOPHEN 325 MG PROPOXYPHENE NAPSYLATE 100 MG | 99P-2247/CP1 MIKART INC. | TABLET; ORAL, CAPSULE;ORAL | Denied | 3/2/2001 |
| ACETAMINOPHEN 325 MG ; 325 MG OXYCODONE HYDROCHLORIDE 4.5 MG ; 2.25 MG | 98P-1219/CP1 KING AND SPALDING | TABLET; ORAL | Denied | 2/26/2001 |
| ACETAMINOPHEN 400 MG BUTALBITAL 50 MG | 07P-0030/CP1 LACHMAN CONSULTANT SERVICES | CAPSULES | Approved | 6/9/2008 |
| ACETAMINOPHEN 400 MG;400 MG:400MG HYDROCODONE BITARTRATE 5MG;7.5 MG:10 MG | 99P-4107/CP1 PHARMACEUTICAL ASSOCIATES, INC | LIQUID; ORAL | Denied | 3/2/2001 |
| ACETAMINOPHEN 50 MG PROPOXYPHENE NAPSYLATE 500 MG | 99P-4649/CP1 MIKART INC. | TABLET/CAPSULES; ORAL | Denied | 3/1/2001 |
| ACETAMINOPHEN 500 MG | 10P-0011 BRIGHT FUTURE PHARMACEUTICALS | TABLETS | Withdrawn | 1/25/2010 |
| ACETAMINOPHEN 500 MG PROPOXYPHENE HYDROCHLORIDE 32 MG | 85P-0581/CP SOFTAN | SOFT GELATIN CAPSULE | Withdrawn | 3/26/2007 |
| ACETAMINOPHEN 500 MG CODEINE PHOSPHATE 7.5 OR 15 MG | 85P-0543/CP2 SOFTAN | SOFT GELATIN CAPSULE | Withdrawn | 3/26/2007 |
| ACETAMINOPHEN 500 MG CODEINE PHOSPHATE 45 MG | 93P-0314/CP1 MIKART | CAPSULE OR TABLET | Withdrawn | 3/26/2007 |
| ACETAMINOPHEN 500 MG OXYCODONE HYDROCHLORIDE 5 MG | 85P-0543/CP3 SOFTAN | SOFT GELATIN CAPSULE | Withdrawn | 3/26/2007 |
| ACETAMINOPHEN 500 MG CODEINE PHOSPHATE 15 MG, 30 MG, 60 MG | 08P-0127/CP1 LACHMAN CONSULTANT SERVICES | TABLET, EFFERVESCENT | Withdrawn | 3/23/2011 |
| ACETAMINOPHEN 500 MG CODEINE PHOSPHATE 30 MG OR 60 MG | 84P-0228/CP1 MCNEIL | CAPSULE | Withdrawn | 3/26/2007 |
| ACETAMINOPHEN 500 MG BUTALBITAL 50 MG | 99P-2149/CP1 MIKART INC. | TABLET; ORAL, CAPSULE;ORAL | Denied | 4/14/2000 |
| ACETAMINOPHEN 500 mg OXYCODONE HYDROCHLORIDE 10 mg | 99P-2798/CP1 KING AND SPALDING | TABLET; ORAL | Approved | 6/13/2000 |
| ACETAMINOPHEN 500 MG/15 ML OXYCODONE HYDROCHLORIDE 7.5 MG/15 ML | 99P-2776/CP1 KING AND SPALDING | LIQUID; ORAL | Denied | 6/13/2000 |
| ACETAMINOPHEN 534.6 MG CAFFEINE 45 MG | 07P-0272/CP1 LACHMAN CONSULTANT SERVICES | TABLETS | Withdrawn | 11/30/2011 |
| ACETAMINOPHEN 650 MG BUTALBITAL 50 MG | 07P-0194/CP1 LACHMAN CONSULTANT SERVICES | CAPSULES | Withdrawn | 11/30/2011 |
| ACETAMINOPHEN 650 MG CODEINE PHOSPHATE 15 MG | 86P-0200/CP MIKART | CAPSULE OR TABLET | Withdrawn | 3/26/2007 |
| ACETAMINOPHEN 650 MG BUTALBITAL 50 MG | 99P-1657/CP1 MIKART INC. | TABLET; ORAL, CAPSULE;ORAL | Approved | 4/14/2000 |
| ACETAMINOPHEN 750 MG BUTALBITAL 50 MG | 99P-2150/CP1 MIKART INC. | TABLET; ORAL, CAPSULE;ORAL | Approved | 4/14/2000 |
| ACETAMINOPHEN 770 MG, 385 MG CAFFEINE 60 MG, 30 MG | 03P-0505/CP1 LACHMAN CONSULTANT SERVICES | TABLET | Withdrawn | 10/19/2004 |
| ACETAMINOPHEN; 320 MG/10 ML HYDROCODONE BITARTRATE 10 MG/10 ML | 01P-0130/CP2 PHARMACEUTICAL ASSOCIATES, INC | SOLUTION; ORAL | Denied | 7/9/2002 |
| ACETAMINOPHEN; 325 MG & 500MG/15 ML HYDROCODONE BITARTRATE 10 MG/15 ML | 00P-1243/CP1 PHARMACEUTICAL ASSOCIATES, INC | SOLUTION; ORAL | Denied | 5/7/2001 |
| ACETAMINOPHEN; 325 MG/15 ML HYDROCODONE BITARTRATE 7.5 MG/15 ML | 01P-0214/CP1 PHARMACEUTICAL ASSOCIATES | SOLUTION; ORAL | Approved | 8/20/2001 |
| ACETAMINOPHEN; 325mg and 325 mg OXYCODONE HYDROCHLORIDE 7.5 mg and 10 mg | 00P-1270/CP1 KING AND SPALDING | TABLET; ORAL | Approved | 9/9/2000 |
| ACETAMINOPHEN; 325MG/10ML HYDROCODONE BITARTRATE 10MG/10ML | 00P-1291/CP1 PHARMACEUTICAL ASSOCIATES, INC | SOLUTION; ORAL | Denied | 5/7/2001 |
| ACETAMINOPHEN; 400mg per tab OXYCODONE HYDROCHLORIDE 2.5mg;5mg;7.5mg;10mg | 00P-1271/CP1 KING AND SPALDING | TABLET; ORAL | Approved | 9/9/2000 |
| ACETAMINOPHEN; 500 MG HYDROCODONE BITARTRATE 10 MG | 01P-0251/CP1 MALLINKRODT | SOLUTION; ORAL | Withdrawn | 8/23/2001 |
| ACETAMINOPHEN; 500 MG PROPOXYPHENE NAPSYLATE 100 MG | 00P-1324/CP1 MIKART | TABLETS AND/OR CAPSULES | Denied | 4/30/2001 |
| ACETAMINOPHEN; 500 MG/15 ML HYDOCODONE BITARTRATE 10 MG/15 ML | 01P-0144/CP1 PHARMACEUTICAL ASSOCIATES INC. | SOLUTION; ORAL | Approved | 8/20/2001 |
| ACETAMINOPHEN; 650 MG/ 30 ML HYDROCODONE BITARTRATE 10 MG/30 ML | 00P-1243/CP2 PHARMACEUTICAL ASSOCIATES INC. | SOLUTION; ORAL | Denied | 5/7/2001 |
| ACETAMINOPHEN; 650 MG/15 ML HYDROCODONE BITARTRATE 10 MG/15 ML | 01P-0130/CP1 PHARMACEUTICAL ASSOCIATES, INC | SOLUTION; ORAL | Approved | 8/20/2001 |
| ACETAMINOPHEN; 650MG/30 ML HYDROCODONE BITARTRATE 10MG/30ML | 00P-1431/CP1 PHARMACEUTICAL ASSOCIATES INC | SOLUTION; ORAL | Withdrawn | 9/6/2000 |
| ACYCLOVIR 200 MG | 99P-5452/CP1 THE WEINBERG GROUP INC | TABLETS FOR ORAL SUSPENSION | Approved | 6/13/2000 |
| ACYCLOVIR 400MG & 800 MG | 99P-5453/CP1 THE WEINBERG GROUP INC. | TABLET; FOR ORAL SUSPENSION | Approved | 6/13/2000 |
| ACYCLOVIR 5% | 96P-0307/CP1 PITNEY, HARDIN, KIPP & SZUCH | CREAM; TOPICAL | Withdrawn | 3/26/2007 |
| ACYCLOVIR SODIUM 5 MG/ML | 95P-0268/CP1 WILMER, CUTLER, PICKERING | READY TO USE INFUSION | Withdrawn | 3/26/2007 |
| ADENOSINE 18 MG/6 ML 30 MG/10 ML | 04P-0326/CP1 APOTEX CORPORATION | INJECTION | Denied | 8/22/2007 |
| ALBUTEROL SULFATE .083% (base) | 02P-0448/CP1 SENSORMEDICS CORPORATION | INHALATION SOLUTION | Denied | 12/17/2003 |
| ALBUTEROL SULFATE 0.0417% | 00P-0913/CP1 MCDERMOTT, WILL AND EMERY | SOLUTION; INHALATION | Approved | 6/13/2000 |
| ALBUTEROL SULFATE 0.25% | 08P-0344/CP1 NEPHRON PHARMACEUTICALS | SOLUTION; INHALATION | Pending | 6/18/2008 |
| ALBUTEROL SULFATE 2 MG & 4 MG | 97P-0387/CP1 RICHARD A. HAMER ASS., INC. | TABLET; SUBLINGUAL | Withdrawn | 3/26/2007 |
| ALBUTEROL SULFATE 2 MG, AND 4 MG | 92P-0335/CP1 WE PHARMS | CHEWABLE TABLET | Withdrawn | 3/26/2007 |
| ALBUTEROL SULFATE 4 MG | 91P-0348/CP1 HAMER | CAPSULE; ETENDED-RELEASE | Withdrawn | 3/26/2007 |
| ALCLOMETASONE DIPROPIONATE 0.05% | 06P-0369/CP1 KIRKPATRICK & LOCKHART | LOTION; TOPICAL | Withdrawn | 1/6/2012 |
| ALLOPURINOL 100 MG PER 5 ML | 08P-0209/CP1 NEW ENGLAND BIOMEDICAL RESEARC | SUSPENSION | Pending | 4/16/2008 |
| ALLOPURINOL 100 MG/5 ML | 11P-0740 ALLAN M. GREEN, M.D. | LIQUID SUSPENSION | Pending | 10/24/2011 |
| ALPRAZOLAM 0.25 MG | 06P-0288/CP1 BECKLOFF ASSOCIATES | ORALLY DISINTEGRATING TABLETS | Pending | 8/1/2006 |
| AMINO ACID 15% | 07P-0113/CP1 B BRAUN MEDICAL | INJECTION | Approved | 4/8/2009 |
| AMINO ACID 15 % 1 L GLASS BOTTLE | 07P-0300/CP1 B. BRAUN MEDICAL | INJECTION | Approved | 4/8/2009 |
| AMINO ACIDS 10% 1000mL & 2000mL | 00P-1470/CP1 BAXTER HEALTHCARE CORP | INJECTION | Approved | 1/11/2001 |
| AMIODARONE 100 MG | 01P-0445/CP1 TARO | TABLET; ORAL | Withdrawn | 10/16/2001 |
| AMIODARONE 400 MG | 99P-0343/CP1 OLSON FRANK AND WEEDA | TABLET; ORAL | Approved | 7/21/1999 |
| AMIODARONE HYDROCHLORIDE 100 MG | 01P-0125/CP1 OLSON, FRANK AND WEEDA, P.C. | TABLET; ORAL | Approved | 8/2/2001 |
| AMIODARONE HYDROCHLORIDE 300 mg | 02P-0394/CP1 TARO RESEARCH INSTITUTE | TABLETS | Approved | 3/6/2003 |
| AMIODARONE HYDROCHLORIDE 300mg/6mL, 450mg/9mL | 02P-0484/CP1 LACHMAN CONSULTANT SERVICES | INJECTION | Approved | 2/25/2003 |
| AMIODARONE HYDROCHLORIDE 450 mg/9 mL | 02P-0480/CP1 BIONICHE PHARMA GROUP | INJECTION | Approved | 2/25/2003 |
| AMIODARONE HYDROCHLORIDE 50 MG/ ML 9 ML VIALS | 02P-0346/CP1 GENSIA SICOR | INJECTION | Approved | 2/25/2003 |
| AMIODARONE HYDROCHLORIDE 50mg/mL, 18mL vial | 02P-0419/CP1 BIONICHE PHARMA GROUP | INJECTION | Withdrawn | 4/22/2003 |
| AMIODARONE HYDROCHLORIDE 900 MG/18 ML | 00P-1352/CP1 GENSIA SICOR | INJECTION | Approved | 1/16/2001 |
| AMLODIPINE 5 MG & 10 MG | 01P-0239/CP1 CIPHER PHARMACEUTICALS LTD. | CAPSULE; ORAL | Withdrawn | 2/12/2004 |
| AMLODIPINE BESYLATE 2.5 MG, 5 MG, 10 MG | 05P-0066/CP1 DLA PIPER RUDNICK GRAY CARY | CAPSULES | Denied | 6/7/2006 |
| AMMONIA N 13 3.75 - 260 mCi/mL | 11P-0337 PRECISION NUCLEAR, LLC | INJECTION | Approved | 9/1/2011 |
| AMOXICILLIN 125MG,250MG,200MG 400MG,500MG,875MG | 99P-5450/CP1 THE WEINBERG GROUP INC. | TABLETS FOR ORAL SUSPENSION | Approved | 6/13/2000 |
| AMOXICILLIN 200 MG, 400 MG CLAVULANATE POTASSIUM 28.5 MG, 57 MG | 04P-0157/CP1 THE WEINBERG GROUP | TABLETS FOR ORAL SUSPENSION | Approved | 9/28/2006 |
| AMOXICILLIN 300 mg, 600 mg | 02P-0358/CP1 THE WEINBERG GROUP | TABLETS FOR ORAL SUSPENSION | Approved | 11/26/2002 |
| AMOXICILLIN 600mg CLAVULANATE POTASSIUM 42.9mg | 02P-0406/CP1 THE WEINBERG GROUP, INC. | TABLETS FOR ORAL SUSPENSION | Denied | 10/15/2004 |
| ASPIRIN 325 MG HYDROCODONE BITARTRATE 5 MG | 12P-1267 XSPIRE PHARMA | TABLET; ORAL | Pending | 1/8/2013 |
| ASPIRIN 356.4MG CAFFEINE 30 MG | 86P-0359/CP CENTRAL PHARMS | TABLET | Withdrawn | 3/26/2007 |
| ASPIRIN 650 MG BUTALBITAL 50 MG | 96P-0021/CP1 SAVAGE LABS | CAPSULES | Withdrawn | 3/26/2007 |
| ATORVASTATIN CALCIUM 10 MG, 20 MG 40 MG, 80 MG | 08P-0085/CP1 LUPIN PHARMACEUTICALS | CAPSULES | Approved | 8/25/2010 |
| ATORVASTATIN CALCIUM 10MG/20MG/40MG/80MG | 04P-0418/CP1 LACHMAN CONSULTANT SERVICES | CAPSULES | Withdrawn | 7/1/2005 |
| ATROPINE SULFATE 1.0 MG/ML | 12P-0986 SHEPPARD MULLIN | INJECTION | Pending | 9/21/2012 |
| AZACITIDINE 150 MG/VIAL | 08P-0418/CP1 REGULUS PHARMACEUTICAL | INJECTION | Pending | 7/28/2008 |
| AZATADINE MALEATE 1 MG PHENYLPROPANOLAMINE HYDROCHLORIDE 75 MG | 85P-0492/CP SKF | EXTENDED-RELEASE CAPSULE | Withdrawn | 3/26/2007 |
| AZATADINE MALEATE 1 MG PHENYLEPHRINE HYDROCHLORIDE 30 MG | 95P-0351/CP1 BOCK PHARMACEUTICAL COMPANY | TABLET; ORAL | Withdrawn | 3/23/2000 |
| AZATHIOPRINE 75 MG & 100 MG | 01P-0379/CP1 AAI INTERNATIONAL | TABLET; ORAL | Approved | 12/17/2001 |
| BACLOFEN 10 mg, 20 mg | 02P-0078/CP1 KLEINFELD, KAPLAN & BECKER | ORALLY DISINTEGRATING TABLETS | Approved | 2/3/2004 |
| BACLOFEN 10 MG/5 ML | 05P-0156/CP1 PHASE V PHARMACEUTICALS | ORAL SOLUTION | Withdrawn | 7/18/2005 |
| BACLOFEN 5 MG | 08P-0325/CP1 KENDLE REGULATORY AFFAIRS | TABLETS | Approved | 3/18/2010 |
| BACTERIOSTATIC WATER 20 ML/30 CC VIAL | 09P-0067/CP1 APP PHARMACEUTICALS | INJECTION | Approved | 6/22/2011 |
| BENZONATATE 125 MG, 175 MG | 09P-0190 LACHMAN CONSULTANT SERVICES | CAPSULES | Pending | 4/21/2009 |
| BENZONATATE 150 MG | 04P-0321/CP1 LACHMAN CONSULTANT SERVICES | CAPSULES | Approved | 11/23/2004 |
| BENZPHETAMINE HYDROCHLORIDE 25 MG, 50 MG | 05P-0406/CP1 LACHMAN CONSULTANT SERVICES | CAPSULES | Approved | 6/27/2007 |
| BENZTROPINE MESYLATE 0.5 MG/5 ML | 85P-0423/CP RIM CONSULTING | SYRUP | Withdrawn | 3/26/2007 |
| BETAMETHASONE VALERATE 0.12% | 06P-0438/CP1 OLSSON, FRANK AND WEEDA | NON-AEROSOL FOAM | Pending | 11/7/2006 |
| BISOPROLOL FUMARATE 5 MG, 10 MG, 20 MG HYDROCHLOROTHIAZIDE 12.5 MG | 07P-0071/CP1 LACHMAN CONSULTANT SERVICES | TABLETS | Pending | 3/15/2007 |
| BORTEZOMIB 1 MG, 2.5 MG | 12P-0272 ACTAVIS | INJECTION | Pending | 3/23/2012 |
| BROMPHENIRAMINE MALEATE 12 MG PSEUDOEPHEDRINE HYDROCHLORIDE 120 MG | 83N-0095/CP UAD LABS | EXTENDED-RELEASE CAPSULE | Withdrawn | 3/26/2007 |
| BUMETANIDE 6.25 MG/25 ML | 05P-0006/CP1 BEN VENUE LABORATORIES | INJECTION | Pending | 1/18/2005 |
| BUPRENORPHINE HYDROCHLORIDE 8 MG NALOXONE HYDROCHLORIDE 2 MG | 09P-0459 AERSCHER LLC | ORAL STRIP | Pending | 9/29/2009 |
| BUTALBITAL 25 MG, 50 MG ACETAMINOPHEN 300 MG, 600 MG | 02P-0056/CP1 SHOTWELL & CARR, INC. | TABLET; ORAL | Pending | 2/28/2003 |
| BUTALBITAL 50 MG ASPIRIN 500 MG | 08P-0155/CP1 LACHMAN CONSULTANT SERVICES | CAPSULES | Approved | 8/18/2010 |
| BUTALBITAL 50 MG ACETAMINOPHEN 325 MG | 95P-0279/CP1 MIKART | CAPSULES AND TABLETS | Withdrawn | 3/26/2007 |
| BUTALBITAL 50 MG ACETAMINOPHEN 325 MG | 95P-0279/CP2 MIKART | CAPSULES AND TABLETS | Withdrawn | 3/26/2007 |
| BUTALBITAL 50 MG ACETAMINOPHEN 500 MG | 95P-0279/CP4 MIKART | CAPSULES AND TABLETS | Withdrawn | 3/26/2007 |
| BUTALBITAL 50 MG ACETAMINOPHEN 300 MG | 11P-0167 LACHMAN CONSULTANT SERVICES | CAPSULES | Approved | 7/7/2012 |
| BUTALBITAL 50 MG ACETAMINOPHEN 500 MG | 95P-0279/CP3 MIKART | CAPSULES AND TABLETS | Withdrawn | 3/26/2007 |
| BUTALBITAL 50 MG ACETAMINOPHEN 300 MG | 06P-0086/CP1 LACHMAN CONSULTANT SERVICES | TABLETS | Approved | 8/18/2006 |
| BUTALBITAL 50 MG ACETAMINOPHEN 300 MG | 11P-0106 LACHMAN CONSULTANT SERVICES | CAPSULES | Withdrawn | 3/28/2011 |
| BUTALBITAL 50 MG ASPIRIN 500 MG | 08P-0156/CP1 LACHMAN CONSULTANT SERVICES | CAPSULES | Approved | 8/18/2010 |
| CALCITONIN, SALMON 2500 IU/0.25 MG | 05P-0070/CP1 LATHAM & WATKINS | TABLET OR CAPSULE | Denied | 6/2/2006 |
| CALCITONIN-SALMON 100 IU/ML-1ML VIALS | 00P-1213/CP1 FERRING PHARMACEUTICALS | INJECTION | Approved | 6/13/2000 |
| CALCIUM ACETATE 667 MG/5 ML | 08P-0175/CP1 BECKLOFF ASSOCIATES | ORAL SOLUTION | Withdrawn | 3/19/2008 |
| CALCIUM ACETATE 667 MG/5 ML | 11P-0115 CYPRESS PHARMACEUTICAL | ORAL SOLUTION | Withdrawn | 5/7/2012 |
| CAPTOPRIL 25 MG/5 ML | 98P-0199/CP1 MIRAN CONSULTING, INC. | SOLUTION; ORAL | Withdrawn | 3/26/2007 |
| CAPTOPRIL 25 MG/ML | 95P-0008/CP1 ROXANE LABS, INC. | ORAL SOLUTION | Withdrawn | 3/26/2007 |
| CARBAMAZEPINE 100mg, 300mg, 400mg | 03P-0083/CP1 TARO PHARMACEUTICALS | TABLETS | Approved | 12/17/2003 |
| CARBAMAZEPINE 200 MG | 01P-0028/CP1 TARO RESEARCH INSTITUTE LTD. | TABLET; CHEWABLE | Approved | 5/8/2001 |
| CARBAMAZEPINE 200 MG/5 ML | 89P-0399/CP GUIDELINES | ORAL SUSPENSION | Withdrawn | 3/26/2007 |
| CARBAMAZEPINE 200 MG/5 ML | 03P-0304/CP1 TARO PHARMACEUTICALS | ORAL SUSPENSION | Denied | 1/16/2013 |
| CARBIDOPA 25 MG; 10 MG; 25 MG LEVODOPA 100MG; 100MG; 250MG | 02P-0033/CP1 LACHMAN CONSULTANT SERVICES | TABLETS; ORALLY DISINTEGRATING | Approved | 9/25/2002 |
| CARBIDOPA/LEVODOPA 25/100 MG 25/250 MG | 95P-0100/CP1 ATHENA NEUROSCIENCES, INC. | POWDER FOR ORAL SOLUTION | Withdrawn | 3/26/2007 |
| CARBIDOPA; 10MG & 25MG & 25MG LEVODOPA 100MG & 100MG &250MG | 01P-0358/CP1 THE WEINBERG GROUP, INC. | TABLET FOR ORAL SUSPENSION | Approved | 8/9/2002 |
| CARBINOXAMINE MALEATE 4 MG | 04P-0451/CP1 NUTEC INCORPORATED | CHEWABLE TABLET | Pending | 10/8/2004 |
| CARBINOXAMINE MALEATE 6 MG | 08P-0167/CP1 LACHMAN CONSULTANT SERVICES | TABLETS | Approved | 3/7/2011 |
| CARBOPLATIN 1000 MG/100 ML | 08P-0660/CP1 ONCOTHERAPIES | INJECTION | Pending | 1/5/2009 |
| CARBOPLATIN 1000 MG/100 ML MULTIPLE DOSE VIAL | 05P-0398/CP1 LACHMAN CONSULTANT SERVICES | INJECTION | Approved | 9/29/2009 |
| CARBOPLATIN 50 MG/5 ML ;10MG/ML 150 MG/15 ML;10MG/ML | 01P-0036/CP1 VENABLE | INJECTION | Approved | 11/30/2001 |
| CARBOPLATIN 600 MG/60 ML | 03P-0220/CP1 FAULDING | INJECTION | Approved | 2/3/2004 |
| CARISOPRODOL 200 MG ACETAMINOPHEN 325 MG | 03P-0460/CP1 ANABOLIC LABORATORIES, INC. | TABLET; ORAL | Pending | 2/4/2004 |
| CARISOPRODOL 200 MG | 01P-0526/CP1 ATLEY PHARMACEUTICALS, INC. | TABLET; ORAL | Denied | 7/3/2002 |
| CARISOPRODOL 350 mg | 02P-0138/CP1 LACHMAN CONSULTANT SERVICES | ORALLY DISINTEGRATING TABLETS | Withdrawn | 7/25/2002 |
| CARVEDILOL PHOSPHATE 10, 20, 40, 80 MG | 07P-0103/CP1 KELLER AND HECKMAN | TABLET; EXTENDED-RELEASE; ORAL | Pending | 4/2/2007 |
| CEFACLOR 125 MG, 187 MG 250 MG, 375 MG | 99P-5447/CP1 THE WEINBERG GROUP INC. | TABLET; CHEWABLE;ORAL | Approved | 6/13/2000 |
| CEFACLOR 125 MG, 375 MG 375 MG, 500 MG | 99P-5448/CP1 THE WEINBERG GROUP INC. | TABLETS FOR ORAL SUSPENSION | Approved | 6/13/2000 |
| CEFACLOR 500 MG | 00P-1397/CP1 THE WEINBERG GROUP INC. | TABLET; CHEWABLE | Approved | 4/17/2001 |
| CEFADROXIL HEMIHYDRATE 125MG,250MG,500MG | 99P-5449/CP1 THE WEINBERG GROUP INC. | TABLETS FOR ORAL SUSPENSION | Approved | 6/13/2000 |
| CEFAZOLIN 2 G VIALS | 07P-0214/CP1 SANDOZ | INJECTION | Pending | 6/5/2007 |
| CEFAZOLIN SODIUM, STERILE 100 G & 300 G | 99P-4870/CP1 QUINN CONSULTING SERVICES | FOR INJECTION | Approved | 4/12/2002 |
| CEFDINIR 187.5, 250, 300 MG | 06P-0265/CP1 LUPIN PHARMACEUTICALS | CHEWABLE TABLETS | Pending | 7/5/2006 |
| CEFDITOREN PIVOXIL 400 MG | 05P-0176/CP1 LACHMAN CONSULTANT SERVICES | TABLETS | Approved | 7/14/2005 |
| CEFEPIME 100 GRAM | 08P-0539/CP1 SAMSOM MEDICAL TECHNOLOGIES | INJECTION USP | Approved | 9/10/2010 |
| CEFEPIME INTRAVENOUS ONLY | 06P-0461 B. BRAUN | INJECTION | Withdrawn | 8/15/2008 |
| CEFIXIME 100 MG/ML | 07P-0404/CP1 LUPIN PHARMACEUTICALS | ORAL SUSPENSION | Approved | 9/1/2010 |
| CEFIXIME 100MG, 150MG, 200MG | 04P-0263/CP1 LUPIN PHARMACEUTICALS | CHEWABLE TABLETS | Approved | 10/6/2005 |
| CEFIXIME 200 MG, 400 MG | 08P-0534/CP1 LUPIN PHARMACEUTICALS | CAPSULES | Withdrawn | 10/24/2011 |
| CEFIXIME 200 MG/5 ML | 05P-0013/CP1 LUPIN PHARMACEUTICALS | ORAL SUSPENSION | Approved | 4/8/2005 |
| CEFOXITIN 100 GRAM, 300 GRAM | 03P-0227/CP1 SAMSON MEDICAL TECHNOLOGIES | INJECTION | Approved | 10/1/2003 |
| CEFPODOXIME PROXETIL 50 mg, 100 mg | 02P-0444/CP1 THE WEINBERG GROUP | TABLETS FOR ORAL SUSPENSION | Denied | 6/7/2005 |
| CEFPROZIL 125 MG, 250 MG | 04P-0173/CP1 LACHMAN CONSULTANT SERVICES | TABLETS FOR ORAL SUSPENSION | Denied | 6/7/2005 |
| CEFTAZIDIME 100GM PHARM BULK PKG | 03P-0292/CP1 SAMSON MEDICAL TECHNOLOGIES | INJECTION | Approved | 12/23/2003 |
| CEFTRIAXONE 100 GRAM | 05P-0114/CP1 SAMSON MEDICAL TECHNOLOGIES | INJECTION | Approved | 7/14/2005 |
| CEFUROXIME AXETIL 125 MG, 250 MG | 02P-0414/PRC THE WEINBERG GROUP | TABLETS FOR ORAL SUSPENSION | Denied | 2/19/2013 |
| CEFUROXIME AXETIL 125mg and 250mg | 02P-0414/CP1 THE WEINBERG GROUP, INC | TABLETS FOR ORAL SUSPENSION | Denied | 4/29/2004 |
| CEFUROXIME SODIUM, STERILE 75 G & 225 G | 99P-4871/CP1 QUINN CONSULTING SERVICES | FOR INJECTION | Approved | 4/12/2002 |
| CEPHALEXIN 125MG,250MG,500MG | 99P-5451/CP1 THE WEINBERG GROUP INC | TABLETS FOR ORAL SUSPENSION | Approved | 6/13/2000 |
| CETIRIZINE HYDROCHLORIDE 5 MG, 10 MG | 06P-0122/CP1 LACHMAN CONSULTANT SERVICES | ORALLY DISINTEGRATING TABLETS | Withdrawn | 1/6/2012 |
| CETIRIZINE HYDROCHLORIDE 5 MG; 10 MG | 06P-0207/CP1 STRIDES | CAPSULES, SOFT GELATIN | Withdrawn | 2/1/2010 |
| CHLORHEXIDINE GLUCONATE 0.5% | 88P-0036/CP ARENT, FOX, ET. AL | SPRAY | Withdrawn | 3/26/2007 |
| CHLORHEXIDINE GLUCONATE 2% ISOPROPYL ALCOHOL 70% | 05P-0074/CP1 APLICARE INC. | TOPICAL SOLUTION | Pending | 4/8/2005 |
| CHLORHEXIDINE GLUCONATE 2% ISOPROPOL ALCOHOL 70% | 04P-0528/CP1 CARDINAL HEALTH | SOLUTION; TOPICAL | Pending | 12/6/2004 |
| CHLORHEXIDINE GLUCONATE 2% W/V ISOPROPYL ALCOHOL 70% V/V | 05P-0226/CP1 APLICARE | PREOPERATIVE SKIN PREP | Pending | 6/17/2005 |
| CHLORPHENIRAMINE MALEATE 8 MG PSEUDOEPHEDRINE HYDROCHLORIDE 120 MG | 09P-0320/CP PHARMA MEDICA | TABLET; EXTENDED-RELEASE; ORAL | Pending | 7/27/2009 |
| CHLORPHENIRAMINE MALEATE 8 MG PSEUDOEPHEDRINE HYDROCHLORIDE 120 MG | 09P-0478 THE WEINBERG GROUP | CAPSULE, EXTENDED RELEASE; ORAL | Pending | 10/13/2009 |
| CHLORZOXAZONE 250 MG | 90P-0084/CP1 MIKART | CAPSULE | Withdrawn | 3/26/2007 |
| CHLORZOXAZONE 375 MG | 05P-0044/CP1 LACHMAN CONSULTANT SERVICES | TABLETS | Approved | 4/8/2005 |
| CHLORZOXAZONE 500 MG | 82N-0032/CP6 MIKART | CAPSULE | Withdrawn | 3/26/2007 |
| CHOLESTYRAMINE 2 G | 95P-0277/CP1 MAYRAND PHARMACEUTICALS, INC | TABLET; ORAL (CHEWABLE) | Withdrawn | 3/26/2007 |
| CHOLESTYRAMINE 4 GM | 86P-0123/CP PARKE DAVIS | CHEWABLE TABLET | Withdrawn | 3/26/2007 |
| CHOLESTYRAMINE 500 MG | 86P-0474/CP BRISTOL MYERS | CAPSULE | Withdrawn | 3/26/2007 |
| CHOLESTYRAMINE RESIN 4 G | 87P-0301/CP CIBA | GEL | Approved | 3/26/2007 |
| CIMETIDINE 200,300,400 OR 800MG | 93P-0048/CP1 FLEMINGTON | EFFERVESCENT TABLET | Withdrawn | 3/26/2007 |
| CIPROFLOXACIN HYDROCHLORIDE 0.4 ML UNIT DOSE | 04P-0222/CP1 STRADLING YOCCA CARLSON & RAUT | OPHTHALMIC SOLUTION | Withdrawn | 11/18/2009 |
| CIPROFLOXACIN HYDROCHLORIDE 100 MG, 250 MG 500 MG, 750 MG | 07P-0100/CP1 JRRAPOZA ASSOCIATES | CAPSULES | Pending | 4/4/2007 |
| CITALOPRAM HYDROBROMIDE 10 MG, 20 MG, 40 MG | 03P-0551/CP1 FROMMER LAWRENCE & HAUG | CAPSULE | Approved | 3/29/2005 |
| CLADRIBINE 2 MG/ML - 5 ML VIAL | 00P-1621/CP1 LIPOMED, INC. | INJECTION | Denied | 8/1/2001 |
| CLARITHROMYCIN 1000 MG | 03P-0238/CP1 THE WEINBERG GROUP | EXTENDED-RELEASE TABLETS | Approved | 12/18/2003 |
| CLEMASTINE FUMARATE 1.34 MG PSEUDOEPHEDRINE HYDROCHLORIDE 120 MG | 87P-0314/CP SANDOZ | CONTROLLED-RELEASE TABLET | Withdrawn | 3/26/2007 |
| CLEMASTINE FUMARATE 1.34 MG PHENYLPROPANOLAMINE HYDROCHLORIDE 75 MG | 88P-0350/CP SCI CONSULTING | EXTENDED-RELEASE CAPSULE | Withdrawn | 3/26/2007 |
| CLINDAMYCIN PHOSPHATE 1% | 07P-0124/CP1 OLSSON, FRANK AND WEEDA | FOAM; NON-AEROSOL | Pending | 4/4/2007 |
| CLOBETASOL PROPIONATE 0.05% | 06P-0387/CP1 PADDOCK LABORATORIES | FOAM | Pending | 9/21/2006 |
| CLOBETASOL PROPIONATE 0.05% RLD = TEMOVATE | 90P-0198/CP KROSS | LOTION | Withdrawn | 3/26/2007 |
| CLOBETASOL PROPIONATE 0.05% RLD = TEMOVATE E | 98P-0068/CP1 RICHARD HAMER ASSOCIATES, INC. | LOTION; TOPICAL | Withdrawn | 3/26/2007 |
| CLONAZEPAM 1 MG/5 ML | 03P-0464/CP1 LACHMAN CONSULTANT SERVICES | ORAL SUSPENSION | Approved | 10/17/2005 |
| CLONIDINE HYDROCHLORIDE 0.05 MG | 08P-0489/CP1 LACHMAN CONSULTANT SERVICES | TABLETS | Denied | 10/19/2010 |
| CLOZAPINE 12.5 MG | 99P-1267/CP1 LACHMAN CONSULTANT SERVICES | TABLET;ORAL | Approved | 2/17/2000 |
| CLOZAPINE 150 MG | 08P-0289/CP1 LACHMAN CONSULTANT SERVICES | TABLETS | Approved | 3/7/2011 |
| CLOZAPINE 150 MG, 200 MG | 08P-0294/CP1 LACHMAN CONSULTANT SERVICES | TABLETS; ORAL DISINTEGRATING | Withdrawn | 3/9/2011 |
| CLOZAPINE 200 MG | 99P-1268/CP1 LACHMAN CONSULTANT SERVICES | TABLET; ORAL | Approved | 2/17/2000 |
| CLOZAPINE 50 mg | 02P-0247/CP1 AAC CONSULTING GROUP | TABLETS | Approved | 11/26/2002 |
| CLOZAPINE 50 MG/ML | 09P-0046/CP1 LACHMAN CONSULTANT SERVICES | ORAL SUSPENSION | Withdrawn | 5/7/2012 |
| CODEINE PHOSPHATE 10 MG/5 ML DEXBROMPHENIRAMINE MALEATE 1 MG/5 ML | 85P-0269/CP BOCK PHARMA | SYRUP | Withdrawn | 3/26/2007 |
| COLCHICINE 0.3 MG, 1.2 MG, 1.8 MG | 12P-0632 PAR PHARMACEUTICALS | TABLETS | Pending | 6/19/2012 |
| COLISTIMETHATE SODIUM 150 MG/2 ML | 05P-0050/CP1 PRG CONSULTING | SOLUTION | Approved | 10/17/2005 |
| CYCLOBENZAPRINE HYDROCHLORIDE 15 MG, 30 MG | 09P-0168 FOLEY & LARDNER | TABLET; EXTENDED-RELEASE; ORAL | Pending | 4/8/2009 |
| CYCLOBENZAPRINE HYDROCHLORIDE 7.5 MG | 03P-0461/CP1 ANABOLIC LABORATORIES | TABLET; ORAL | Approved | 10/15/2004 |
| CYCLOPHOSPHAMIDE 20 MG/ML, 250 ML PBP | 88P-0379/CP BAXTER | INJECTION | Withdrawn | 3/26/2007 |
| CYCLOPHOSPHAMIDE 20 MG/ML, 500 ML,PBP | 88P-0011/CP BAXTER | INJECTION | Withdrawn | 3/26/2007 |
| CYCLOSPORINE 25 MG; 50 MG; 100 MG | 98P-0858/CP1 APOTEX CORP | TABLET; ORAL | Approved | 9/16/1999 |
| CYTARABINE 20 MG/ML, 12.5 ML | 92P-0381/CP1 BRISTOL-MYERS SQUIBB | INJECTION | Withdrawn | 3/26/2007 |
| DACTINOMYCIN 0.5 MG/ML | 09P-0367 PHARMAFORCE | INJECTION | Pending | 8/12/2009 |
| DEFEROXAMINE MESYLATE 1 GRAM | 07P-0216/CP1 BEN VENUE LABORATORIES | INJECTION | Pending | 6/7/2007 |
| DEXAMETHASONE SODIUM PHOSPHATE 10 MG/ML 1 ML FILL SIZE | 07P-0167/CP1 AKORN STRIDES | INJECTION | Pending | 5/9/2007 |
| DEXBROMPHENIRAMINE MALEATE 6 MG PHENYLPROPANOLAMINE HYDROCHLORIDE 75 MG | 85P-0238/CP2 BOCK PHARMA | EXTENDED-RELEASE CAPSULE | Withdrawn | 3/26/2007 |
| DEXBROMPHENIRAMINE MALEATE 6 MG PSEUDOEPHEDRINE SULFATE 120 MG | 85P-0140/CP2 CENTRAL PHARMS | EXTENDED-RELEASE CAPSULE | Withdrawn | 3/26/2007 |
| DEXBROMPHENIRAMINE MALEATE 6 MG PHENYLPROPANOLAMINE HYDROCHLORIDE 75 MG | 87P-0265/CP BOCK PHARMA | CONTROLLED-RELEASE TABLET | Withdrawn | 3/26/2007 |
| DEXBROMPHENIRAMINE MALEATE 6 MG PSEUDOEPHEDRINE HYDROCHLORIDE 120 MG | 85P-0140/CP CENTRAL PHARMS | EXTENDED-RELEASE CAPSULE | Withdrawn | 3/26/2007 |
| DEXMEDETOMIDINE HYDROCHLORIDE 400 MCG/4 ML 1000 MCG/10 ML | 11P-0381 LACHMAN CONSULTANT SERVICES | SOLUTION (CONCENTRATE) | Withdrawn | 10/6/2011 |
| DEXMEDETOMIDINE HYDROCHLORIDE 400 MCG/4 ML VIAL | 12P-1147 FOLEY & LARDNER LLP | INJECTION | Pending | 11/20/2012 |
| DEXTROAMPHETAMINE SULFATE 2.5 MG, 7.5 MG 15 MG, 20 MG, 30 MG | 06P-0267/CP1 LACHMAN CONSULTANT SERVICES | TABLETS | Approved | 3/20/2007 |
| DEXTROAMPHETAMINE SULFATE 2.5 MG, 7.5 MG, 15 MG, 20 MG, 30 MG | 05P-0418/CP1 LACHMAN CONSULTANT SERVICES | TABLETS | Withdrawn | 11/1/2005 |
| DIAZEPAM 2 MG/5 ML | 85P-0499/CP CAROLINA MEDCL | SYRUP | Withdrawn | 3/26/2007 |
| DICLOFENAC POTASSIUM 25 MG | 03P-0298/CP1 THE WEINBERG GROUP | CAPSULES | Withdrawn | 2/3/2004 |
| DICLOFENAC SODIUM 50 MG, 75 MG MISOPROSTOL 200 MCG | 07P-0428/CP1 KING & SPALDING LLP | CAPSULES | Approved | 9/1/2010 |
| DIFLUNISAL USP 375 MG | 07P-0247/CP1 LACHMAN CONSULTANT SERVICES | TABLETS | Approved | 3/7/2011 |
| DIGOXIN 0.05 MG/ML | 01P-0449/CP1 ROXANE LABORATORIES INC. | SOLUTION; ORAL | Withdrawn | 12/20/2001 |
| DIGOXIN 0.25 MG/5 ML | 02P-0503/CP1 ROXANE LABORATORIES | ELIXIR | Withdrawn | |
| DIHYDROERGOTAMINE MESYLATE 2 MG/ML | 03P-0556/CP1 HYMAN, PHELPS & MCNAMARA | INJECTION | Denied | 4/1/2005 |
| DILTIAZEM HYDROCHLORIDE 120 MG 180 MG 240 MG RLD=CARDIAZEM CD | 96P-0510/CP1 LABOPHARM INC. | TABLETS;EXTENDED-RELEASE | Withdrawn | 3/26/2007 |
| DILTIAZEM HYDROCHLORIDE 120 MG 180 MG 240 MG RLD=DILACOR XR | 97P-0192/CP1 LABOPHARM, INC. | TABLET; EXTENDED-RELEASE; ORAL | Withdrawn | 3/26/2007 |
| DILTIAZEM HYDROCHLORIDE 120 MG 180 MG 240 MG RLD = TIAZAC | 97P-0195/CP1 LABOPHARM INC | TABLET; EXTENDED-RELEASE; ORAL | Withdrawn | 3/26/2007 |
| DILTIAZEM HYDROCHLORIDE 125MG/5ML;250MG/10ML | 98P-0189/CP1 BEDFORD LABORATORIES | INJECTION | Withdrawn | |
| DIPHENOXYLATE HYDROCHLORIDE 5 MG ATROPINE SULFATE 0.05 MG/5 ML | 05P-0162/CP1 LACHMAN CONSULTANT SERVICES | ORAL SOLUTION | Denied | 12/10/2008 |
| DIPHENOXYLATE HYDROCHLORIDE 5 MG ATROPINE SULFATE 0.05 MG | 05P-0161/CP1 LACHMAN CONSULTANT SERVICES | TABLETS | Denied | 12/10/2008 |
| DISOPYRAMIDE PHOSPHATE 200 MG OR 300 MG | 84N-0116/CP BIOCRAFT | EXTENDED-RELEASE TABLET | Withdrawn | 3/26/2007 |
| DISULFIRAM 500 MG/30 ML | 85P-0215/CP PADDOCK | ORAL SUSPENSION | Withdrawn | 3/26/2007 |
| DIVALPROEX SODIUM 1000 MG | 03P-0178/CP1 LACHMAN CONSULTANT SERVICES | EXTENDED RELEASE TABLETS | Approved | 8/18/2003 |
| DIVALPROEX SODIUM 750 MG | 04P-0195/CP1 LACHMAN CONSULTANT SERVICES | EXTENDED RELEASE TABLETS | Approved | 9/28/2004 |
| DOCETAXEL 160 MG/8 ML | 12P-0589 ONCO THERAPIES LIMITED | INJECTION | Pending | 6/19/2012 |
| DOCETAXEL 20 MG, 80 MG, 200 MG | 10P-0086 HYMAN, PHELPS & MCNAMARA | INJECTION; POWDER FOR SOLUTION | Denied | 1/19/2011 |
| DOCETAXEL 20 MG/ML | 10P-0130 ONCOTHERAPIES | INJECTION | Withdrawn | 5/7/2012 |
| DOCETAXEL 200 MG | 10P-0639 MIKE BERNSTEIN | INJECTION | Approved | 3/27/2012 |
| DONEPEZIL HYDROCHLORIDE 5 MG, 10 MG | 07P-0226/CP1 LACHMAN CONSULTANT SERVICES | ORALLY DISSOLVING FILM STRIPS | Withdrawn | 6/1/2009 |
| DOXORUBICIN HYDROCHLORIDE 100 MG/50 ML | 12P-0200 PHARMAFORCE | INJECTION | Approved | 1/23/2013 |
| DOXYCYCLINE 150 MG | 04P-0219/CP1 LACHMAN CONSULTANT SERVICES | CAPSULES | Approved | 9/28/2004 |
| DOXYCYCLINE 150 MG | 01P-0516/CP1 LACHMAN CONSULTANT SERVICES | TABLET; ORAL | Approved | 4/12/2002 |
| DOXYCYCLINE 50 MG AND 100 MG | 99P-4958/CP1 LACHMAN CONSULTANT SERVICES | TABLET; ORAL | Approved | 2/4/2000 |
| DOXYCYCLINE 75 MG | 01P-0515/CP1 LACHMAN CONSULTANT SERVICES | TABLET; ORAL | Approved | 4/12/2002 |
| DOXYCYCLINE 75 MG | 01P-0109/CP1 THE WEINBERG GROUP INC. | CAPSULE; ORAL | Approved | 8/2/2001 |
| DOXYCYCLINE (MONOHYDRATE) 125 MG | 06P-0417/CP1 LACHMAN CONSULTANT SERVICES | TABLETS | Pending | 10/24/2006 |
| DOXYCYCLINE HYCLATE 75 MG, 100 MG | 04P-0054/CP1 URL MUTUAL | CAPSULES | Withdrawn | 4/12/2004 |
| DOXYCYCLINE HYCLATE 75 MG, 100 MG | 04P-0390/CP1 LACHMAN CONSULTANT SERVICES | TABLETS | Pending | 9/21/2004 |
| DRONABINOL 0.25 MG, 0.5 MG, 1.0 MG | 10P-0353 K & L GATES | NASAL SPRAY | Pending | 7/7/2010 |
| DULOXETINE HYDROCHLORIDE 40 MG | 10P-0535 HYMAN, PHELPS & MCNAMARA | CAPSULE, DELAYED RELEASE | Approved | 4/18/2012 |
| ECONAZOLE NITRATE 1% | 98P-0745/CP1 MIRAN CONSULTING, INC. | OINTMENT; TOPICAL | Withdrawn | 3/26/2007 |
| EDETATE DISODIUM | 05P-0085/CP1 MCGUFF PHARMACEUTICALS | INJECTION | Pending | 2/23/2005 |
| EFAVIRENZ 50 MG, 100 MG,200 MG | 08P-0460/CP1 MATRIX LABORATORIES | TABLETS | Pending | 8/27/2008 |
| EFAVIRENZ 50 MG/100 MG/200 MG | 05P-0407/CP1 LACHMAN CONSULTANT SERVICES | TABLETS FOR ORAL SUSPENSION | Withdrawn | 1/11/2010 |
| EPIRUBICIN HYDROCHLORIDE 10mg/ 5mL;150mg/75mL | 03P-0110/CP1 FAULDING PHARMACEUTICAL CO. | INJECTION | Approved | 8/13/2003 |
| EPIRUBICIN HYDROCHLORIDE 2 MG/ML 10 MG/5 ML | 06P-0131/CP1 AAC CONSULTING | INJECTION | Pending | 4/11/2006 |
| ESCITALOPRAM OXALATE 10 MG, 20 MG | 04P-0247/CP1 FROMMER LAWRENCE & HAUG | CAPSULE | Approved | 3/29/2005 |
| ESCITALOPRAM OXALATE 5 MG, 10 MG, 20 MG | 08P-0216/CP1 LUPIN PHARMACEUTICALS | TABLETS, ORALLY DISINTEGRATING | Pending | 4/16/2008 |
| ESCITALOPRAM OXALATE 5 MG, 10 MG, 20 MG | 07P-0239/CP1 LACHMAN CONSULTANT SERVICES | ORALLY DISSOLVING FILM STRIPS | Withdrawn | 6/1/2009 |
| ESMOLOL HYDROCHLORIDE 2500 MG/VIAL | 04P-0085/CP1 BEDFORD LABORATORIES | INJECTION | Denied | 6/7/2005 |
| ESOMEPRAZOLE MAGNESIUM 20 MG, 40 MG | 08P-0080/CP1 LUPIN PHARMACEUTICALS | TABLETS, DELAYED-RELEASE | Pending | 2/7/2008 |
| ESTROPIPATE 1.2 mg | 02P-0141/CP1 WOMEN FIRST HEALTHCARE | TABLETS | Approved | 9/24/2002 |
| ETHINYL ESTRADIOL 0.035 MG NORETHINDRONE 0.4 MG | 99P-1150/CP1 KIRKLAND & ELLIS | TABLET; CHEWABLE | Approved | 4/14/2000 |
| FAMOTIDINE 10 MG | 97P-0404/CP1 THOMAS BLAKE, R.PH | TABLET; ORAL; EFFERVESCENT | Withdrawn | 3/26/2007 |
| FAMOTIDINE 10 MG | 04P-0353/CP1 LACHMAN CONSULTANT SERVICES | ORALLY DISSOLVING STRIPS | Approved | 7/5/2005 |
| FAMOTIDINE 10MG | 00P-1422/CP1 YAMANOUCHI PHARMA TECHNOLOGIES | TABLET; ORALLY DISINTEGRATING | Approved | 4/17/2001 |
| FASPROFEN 100 MG | 12P-1112 NOBEL LABORATORIES, LLC | ORALLY DISINTEGRATING TABLET | Pending | 11/14/2012 |
| FENOFIBRATE 107 mg | 02P-0148/CP1 LAVENDER CONSULTING SERVICES | TABLETS | Approved | 9/25/2002 |
| FENOPROFEN CALCIUM 400 MG | 07P-0293/CP1 EMCURE PHARMACEUTICALS | CAPSULES | Withdrawn | 9/28/2009 |
| FENTANYL 12.5 mcg/hr | 02P-0478/CP1 LACHMAN CONSULTANT SERVICES | TRANSDERMAL SYSTEM | Withdrawn | 10/14/2003 |
| FENTANYL 37.5 mcg/hr 62.5 mcg/hr | 04P-0069/CP1 LACHMAN CONSULTANT SERVICES | TRANSDERMAL SYSTEM | Approved | 7/7/2004 |
| FENTANYL CITRATE 1000 MCG, 1400 MCG | 07P-0022/CP1 LACHMAN CONSULTANT SERVICES | ORAL TRANSMUCOSAL | Approved | 5/9/2011 |
| FENTANYL CITRATE 50 MCG/1 ML | 10P-0413 OLSSON FRANK WEEDA | INJECTION | Approved | 1/28/2013 |
| FENTANYL CITRATE 500 ML VIAL | 10P-0222 PATRICK FOSTER | INJECTION SOLUTION | Withdrawn | 5/7/2012 |
| FEXOFENADINE HCL 120 MG | 10P-0230 HYMAN, PHELPS & MCNAMARA | TABLETS | Withdrawn | 5/10/2010 |
| FEXOFENADINE HCL 15 MG | 10P-0232 HYMAN, PHELPS & MCNAMARA | ORALLY DISINTEGRATING TABLET | Withdrawn | 3/1/2011 |
| FEXOFENADINE HCL 15 MG/5 ML | 10P-0231 HYMAN, PHELPS & MCNAMARA | SUSPENSION; ORAL | Approved | 1/28/2013 |
| FEXOFENADINE HYDROCHLORIDE 30 MG/5 ML 60 MG/5 ML | 06P-0397/CP1 LUPIN PHARMACEUTICALS | ORAL SUSPENSION | Pending | 10/6/2006 |
| FLOXURIDINE 500 MG/5 ML | 86P-0242/CP QUAD | INJECTION | Withdrawn | 3/26/2007 |
| FLUCONAZOLE 100 MG/50 ML | 04P-0434/CP1 BEN VENUE LABORATORIES | INJECTION | Approved | 8/18/2006 |
| FLUDARABINE PHOSPHATE 25 mg/mL | 02P-0245/CP1 GENSIA SICOR PHARMACEUTICALS | SOLUTION FOR INJECTION | Approved | 4/27/2004 |
| FLUDEOXYGLUCOSE F 18 500 MCI/ML | 10P-0444 MAYO CLINIC | INJECTION | Approved | 5/20/2011 |
| FLUDEOXYGLUCOSE F18 0.9-475 MCI/ML | 07P-0126/CP1 PFI LLC | INJECTION | Pending | 4/9/2007 |
| FLUDEOXYGLUCOSE F18 1-20 mCi/mL EOS | 12P-0387 ABT MOLECULAR IMAGING | INJECTION | Approved | 6/7/2012 |
| FLUOCINOLONE ACETONIDE 0.01% HYDROQUINONE 4% | 03P-0279/CP1 JERUSSI CONSULTING | TOPICAL SOLUTION | Denied | 4/1/2005 |
| FLUOCINONIDE 0.05% | 87P-0004/CP HAMER | LOTION | Denied | 3/26/2007 |
| FLUOROURACIL 1 GM/20 ML | 08P-0003/CP1 EBEWE PARENTA | INJECTION | Pending | 1/10/2007 |
| FLUOROURACIL 2.5% | 01P-0288/CP1 Ferndale Laboratories Inc. | SOLUTION; TOPICAL | Approved | 1/8/2002 |
| FLUOROURACIL 5% | 94P-0263/CP1 BRADLEY PHARMS | TOPICAL GEL | Withdrawn | 3/26/2007 |
| FLUOXETINE 20 MG & 40 MG | 01P-0243/CP1 CIPHER PHARMACEUTICALS LTD. | CAPSULE; ORAL | Withdrawn | 7/31/2001 |
| FLUOXETINE 40 MG | 00P-1365/CP1 LACHMAN CONSULTANT SERVICES | TABLET; ORAL | Approved | 1/12/2001 |
| FLURANDRENOLIDE 0.004 MG/SQ | 09P-0229/CP1 SCARGUARD LABS | TOPICAL LIQUID | Pending | 5/27/2009 |
| FLURAZEPAM HYDROCHLORIDE 15 MG/5ML | 85P-0091/CP ROXANE | ORAL SOLUTION | Withdrawn | 3/26/2007 |
| FLURAZEPAM HYDROCHLORIDE 30 MG/ML | 85P-0081/CP ROXANE | ORAL SOLTUION | Withdrawn | 3/26/2007 |
| GABAPENTIN 100MG,300MG,400MG | 00P-1419/CP1 LACHMAN CONSULTANT SERVICES | TABLET; ORAL | Approved | 1/12/2001 |
| GANCICLOVIR SODIUM 50 MG/ML | 09P-0222/CP1 PHARMAFORCE | INJECTION | Approved | 11/16/2010 |
| GANCICLOVIR SODIUM 500 MG/10 ML | 01P-0440/CP1 BEN VENUE LAOBRATORIES, INC. | INJECTION | Approved | 2/3/2004 |
| GEMCITABINE 2 GM/VIAL | 06P-0145/CP1 LACHMAN CONSULTANT SERVICES | INJECTION | Approved | 8/22/2007 |
| GEMCITABINE HCL 38 MG/ML | 08P-0392/CP1 OLSSON FRANK & WEEDA | INJECTION | Withdrawn | 12/3/2009 |
| GEMCITABINE HYDROCHLORIDE 10 MG/ML | 10P-0096 ONCOTHERAPIES LIMITED | INJECTION | Pending | 2/24/2010 |
| GEMCITABINE HYDROCHLORIDE 38 MG/ML | 09P-0076/CP1 PHARMAFORCE | INJECTION | Pending | 2/19/2009 |
| GLIMEPIRIDE 3 MG, 6 MG | 04P-0123/CP1 LACHMAN CONSULTANT SERVICES | TABLETS | Approved | 7/7/2004 |
| GLIMEPIRIDE 8 MG | 03P-0283/CP1 LACHMAN CONSULTANT SERVICES | TABLETS | Approved | 10/6/2003 |
| GLIPIZIDE 2.5 MG, 5 MG METFORMIN HYDROCHLORIDE 250 MG, 500 MG | 03P-0218/CP1 THE WEINBERG GROUP | TABLETS FOR ORAL SOLUTION | Approved | 7/30/2004 |
| GLIPIZIDE 2.5 mg, 5 mg METFORMIN HYDROCHLORIDE 250mg/5mL;500mg/10mL | 04P-0168/CP1 LACHMAN CONSULTANT SERVICES | ORAL SOLUTION | Approved | 11/23/2004 |
| GLIPIZIDE 2.5 MG, 5 MG METFORMIN HYDROCHLORIDE 250 MG, 500 MG | 04P-0208/CP1 THE WEINBERG GROUP | TABLETS FOR ORAL SUSPENSION | Approved | 11/23/2004 |
| GLYBURIDE 1.25 MG, 2.5 MG, 5MG METFORMIN HYDROCHLORIDE 250 MG, 500 MG | 04P-0209/CP1 THE WEINBERG GROUP | TABLETS FOR ORAL SUSPENSION | Approved | 11/23/2004 |
| GLYBURIDE 1.25MG, 2.5MG, 5 MG METFORMIN HYDROCHLORIDE 250MG, 500MG, | 03P-0534/CP1 LACHMAN CONSULTANT SERVICES | ORAL SOLUTION | Approved | 7/30/2004 |
| GLYBURIDE 1.25mg, 2.5mg, 5mg METFORMIN HYDROCHLORIDE 250mg, 500mg, 500mg | 03P-0188/CP1 THE WEINBERG GROUP | TABLETS FOR ORAL SOLUTION | Approved | 7/30/2004 |
| GLYCOPYRROLATE 1 MG/5 ML | 08P-0414/CP1 LACHMAN CONSULTANT SERVICES | SOLUTION | Withdrawn | 3/9/2011 |
| GLYCOPYRROLATE 1.5 MG | 06P-0300/CP1 LACHMAN CONSULTANT SERVICES | TABLETS | Approved | 3/20/2007 |
| GRISEOFULVIN ULTRAMICROSIZE 250 MG/5 ML | 08P-0303/CP1 EMCURE PHARMACEUTICALS | SUSPENSION; ORAL | Approved | 12/29/2011 |
| HOMATROPINE METHYLBROMIDE 1.5 MG HYDROCODONE BITARTRATE 5 MG | 88P-0061/CP KLEINFELD, KAPLAN & BECKER | SOFT GELATIN CAPSULE | Withdrawn | 3/26/2007 |
| HYDRALAZINE HYDROCHLORIDE 25 MG/5ML | 85P-0074/CP ROXANE | ORAL SOLUTION | Withdrawn | 3/26/2007 |
| HYDROCHLOROTHIAZIDE 12.5 MG | 05P-0060/CP1 LACHMAN CONSULTANT SERVICES | TABLETS | Approved | 4/8/2005 |
| HYDROCHLOROTHIAZIDE 50 MG TRIAMTERENE 75 MG | 86P-0427/CP PAR | CAPSULE | Withdrawn | 3/26/2007 |
| HYDROCODONE BITARTRATE 10 MG ACETAMINOPHEN 300 MG | 01P-0441/CP1 LACHMAN CONSULTANT SERVICES | TABLET; ORAL | Approved | 12/20/2001 |
| HYDROCODONE BITARTRATE 10 MG IBUPROFEN 200 MG | 01P-0442/CP1 LACHMAN CONSULTANT SERVICES | TABLET; ORAL | Approved | 12/20/2001 |
| HYDROCODONE BITARTRATE 10 MG, 7.5 MG ACETAMINOPHEN 400 MG, 400 MG | 01P-0504/CP1 SHOTWELL & CARR, INC. | TABLET; ORAL | Withdrawn | 1/2/2002 |
| HYDROCODONE BITARTRATE 10 MG/15 ML ACETAMINOPHEN 300 MG/15 ML | 01P-0524/CP1 LACHMAN CONSULTANT SERVICES | SOLUTION; ORAL | Approved | 8/6/2002 |
| HYDROCODONE BITARTRATE 2.5 MG HOMATROPINE METHYLBROMIDE 0.75 MG | 07P-0134/CP1 LACHMAN CONSULTANT SERVICES | TABLETS | Pending | 4/12/2007 |
| HYDROCODONE BITARTRATE 2.5 MG IBUPROFEN 200 MG | 05P-0180/CP1 LACHMAN CONSULTANT SERVICES | TABLETS | Approved | 7/14/2005 |
| HYDROCODONE BITARTRATE 2.5 MG PER 5 ML HOMATROPINE METHYLBROMIDE 0.75 MG PER 5 ML | 07P-0119/CP1 LACHMAN CONSULTANT SERVICES | SYRUP | Pending | 4/5/2007 |
| HYDROCODONE BITARTRATE 2.5, 3.75, 5 MG ACETAMINOPHEN 250 MG, 325 MG | 12P-0964 LANNETT COMPANY | TABLETS | Withdrawn | 12/6/2012 |
| HYDROCODONE BITARTRATE 2.5, 5, 7.5, 10 MG ACETAMINOPHEN 500 MG | 08P-0134/CP1 LACHMAN CONSULTANT SERVICES | TABLET; EFFERVESCENT | Withdrawn | 3/23/2011 |
| HYDROCODONE BITARTRATE 2.5, 5, 7.5, 10 MG ASPIRIN 325 MG | 08P-0438/CP1 LACHMAN CONSULTANT SERVICES | TABLETS | Pending | 8/12/2008 |
| HYDROCODONE BITARTRATE 2.5, 5, 7.5, 10 MG ACETAMINOPHEN 325 MG | 11P-0302 LACHMAN CONSULTANT SERVICES | EFFERVESCENT TABLETS | Denied | 7/30/2012 |
| HYDROCODONE BITARTRATE 5 MG ACETAMINOPHEN 325 MG | 03P-0475/CP1 INT'L REGULATORY BUSINESS CONS | LIQUID; ORAL | Withdrawn | 2/4/2004 |
| HYDROCODONE BITARTRATE 5 mg ACETAMINOPHEN 500 mg | 02P-0233/CP1 KLEINFELD, KAPLAN AND BECKER | ORALLY DISINTEGRATING TABLETS | Approved | 2/11/2004 |
| HYDROCODONE BITARTRATE 5 MG ACETAMINOPHEN 300 MG | 03P-0414/CP1 LACHMAN CONSULTANT SERVICES | TABLET | Approved | 11/23/2004 |
| HYDROCODONE BITARTRATE 5 mg IBUPROFEN 200 mg | 02P-0270/CP1 SCIREGS CONSULTING | TABLETS | Approved | 9/25/2002 |
| HYDROCODONE BITARTRATE 5 MG HOMATROPINE METHYLBROMIDE 1.5 MG | 07P-0307/CP1 LACHMAN CONSULTANT SERVICES | CAPSULES | Pending | 8/10/2007 |
| HYDROCODONE BITARTRATE 5 MG BUTALBITAL 50 MG | 03P-0398/CP1 INTN'L REGULATORY BUSINESS | CAPSULE | Withdrawn | |
| HYDROCODONE BITARTRATE 5 MG, 7.5 MG, 10 MG ACETAMINOPHEN 700 MG | 04P-0252/CP1 LACHMAN CONSULTANT SERVICES | TABLETS | Approved | 10/17/2005 |
| HYDROCODONE BITARTRATE 5 MG, 7.5 MG, 10 MG IBUPROFEN 400 MG | 03P-0331/CP1 LACHMAN CONSULTANT SERVICES | TABLETS | Denied | 4/1/2005 |
| HYDROCODONE BITARTRATE 5 MG, 7.5MG & 10 MG ACETAMINOPHEN 300 MG,300 MG&300 MG | 03P-0436/CP1 ANABOLIC LABORATORIES, INC. | TABLET; ORAL | Denied | 10/10/2003 |
| HYDROCODONE BITARTRATE 7.5 MG ACETAMINOPHEN 300 MG | 03P-0413/CP1 LACHMAN CONSULTANT SERVICES | TABLET | Approved | 9/28/2004 |
| HYDROCODONE BITARTRATE 7.5 mg IBUPROFEN 200 mg | 02P-0386/CP1 PHARMACEUTICAL ASSOCIATES | ORAL SUSPENSION | Approved | 2/3/2004 |
| HYDROCODONE BITARTRATE 7.5 MG & 10 MG ACETAMINOPHEN 250 MG & 250 MG | 01P-0521/CP1 SHOTWELL & CARR, INC. | TABLET; ORAL | Denied | 7/3/2002 |
| HYDROCODONE BITARTRATE 7.5 MG/15ML ACETAMINOPHEN 325MG/15ML | 01P-0374/CP1 LACHMAN CONSULTANT SERVICES | SOLUTION; ORAL | Withdrawn | 1/7/2002 |
| HYDROCODONE BITARTRATE; 10 MG/15 ML ACETAMINOPHEN 325 MG/15ML | 00P-1641/CP1 PHARMACEUTICAL ASSOCIATES INC. | SOLUTION; ORAL | Approved | 4/17/2001 |
| HYDROCODONE POLISTIREX 5 MG, 10 MG CHLORPHENIRAMINE POLISTIREX 4 MG, 8 MG | 03P-0091/CP1 LACHMAN CONSULTANT SERVICES | EXTENDED RELEASE CAPSULES | Approved | 8/31/2004 |
| HYDROCORTISONE ACETATE 1% | 90P-0154/CP FERNDALE | OINTMENT | Withdrawn | 3/26/2007 |
| HYDROCORTISONE ACETATE 2% | 01P-0085/CP1 FERNDALE LABORATORIES INC. | CREAM; TOPICAL | Approved | 8/1/2001 |
| HYDROCORTISONE ACETATE 2.5% | 01P-0355/CP1 FERNDALE LABORATORIES INC | SUSPENSION; TOPICAL | Pending | |
| HYDROCORTISONE ACETATE 2.5% | 92P-0101/CP HOGAN & HARTSON | AEROSOL | Withdrawn | 3/26/2007 |
| HYDROCORTISONE ACETATE 2.5% | 01P-0511/CP1 FERNDALE LABORATORIES, INC. | LOTION; TOPICAL | Pending | 2/3/2004 |
| HYDROCORTISONE ACETATE 2.5% OR 1% | 90P-0049/CP FERNDALE | CREAM OR LOTION | Withdrawn | 3/26/2007 |
| HYDROCORTISONE ACETATE 90 MG | 96P-0376/CP1 PITNEY, HARDIN, KIPP & SZUCH | SUPPOSITORY; RECTAL | Withdrawn | 3/26/2007 |
| HYDROCORTISONE BUTYRATE 0.1% | 95P-0223/CP1 MCKENNA & CUNEO, L.L.P. | LOTION; TOPICAL | Withdrawn | 3/26/2007 |
| HYDROCORTISONE VALERATE 0.2% | 89P-0029/CP MCKENNA, CONNER, ET AL | TOPICAL SOLUTION | Withdrawn | 3/26/2007 |
| HYDROCORTISONE VALERATE 0.2% | 89P-0028/CP MCKENNA, CONNER, ET AL | LOTION | Withdrawn | 3/26/2007 |
| HYDROMORPHONE HYDROCHLORIDE 0.2 MG/ML - 30 ML | 98P-0821/CP1 ABBOTT LABORATORIES | INJECTABLE; INJECTION | Denied | 9/29/1999 |
| HYDROMORPHONE HYDROCHLORIDE 2 MG, 4 MG | 04P-0152/CP1 THE WEINBERG GROUP | TABLETS | Approved | 9/28/2004 |
| HYDROQUINONE 4% TRETINOIN 0.01% | 03P-0365/CP1 JERUSSI CONSULTING | TOPICAL SOLUTION | Denied | 12/2/2004 |
| HYDROXYCHLOROQUINE SULFATE 100, 300, 400 MG | 13P-0170 CLINIPACE | TABLET | Pending | 2/19/2013 |
| IBUPROFEN 100 MG/5 ML | 10P-0145 ACTAVIS | SUSPENSION; ORAL | Pending | 4/8/2010 |
| IBUPROFEN 200 MG | 99P-0683/CP1 FPC CONSULTING INC. | TABLET; ORAL | Withdrawn | 9/16/1999 |
| IBUPROFEN 300, 400 OR 600 MG | 85P-0563/CP SOFTAN | SOFT GELATIN CAPSULE | Withdrawn | 3/26/2007 |
| IBUPROFEN 800 MG | 87P-0242/CP SIDMAK | SOFT GELATIN CAPSULE | Withdrawn | 3/26/2007 |
| IBUPROFEN POTASSIUM 200 MG PHENYLEPHRINE HYDROCHLORIDE 10 MG | 06P-0469/CP1 STRIDES | CAPSULES | Pending | 11/28/2006 |
| IFOSFAMIDE 50 MG/ML - 20ML&60ML | 98P-0146/CP1 MITCHALL G. CLARK | INJECTABLE; INJECTION | Withdrawn | 3/26/2007 |
| IMATINIB 400 MG/5 ML | 12P-0479 NATCO PHARMA LIMITED | ORAL SOLUTION | Pending | 5/24/2012 |
| IMATINIB MESYLATE 100 MG, 400 MG, | 10P-0360 HYMAN, PHELPS & MCNAMARA | CAPSULES | Pending | 7/12/2010 |
| IMATINIB MESYLATE 50 MG, 200 MG, 600 MG | 10P-0341 HYMAN, PHELPS & MCNAMARA | TABLETS | Approved | 11/15/2012 |
| IOPAMIDOL | 00P-1452/CP1 COOK IMAGING CORP. | INJECTION | Approved | 4/23/2001 |
| IRINOTECAN HYDROCHLORIDE 500 MG/25 ML | 05P-0496/CP1 MAYNE PHARMA | INJECTION | Approved | 1/16/2007 |
| ISONIAZID 100 MG, 300 MG | 08P-0251/CP1 LACHMAN CONSULTANT SERVICES | TABLETS; ORAL SUSPENSION | Pending | 5/5/2008 |
| ISOTRETINOIN 30 mg | 02P-0161/CP1 LACHMAN CONSULTANT SERVICES | CAPSULES | Approved | 8/8/2002 |
| KALEXATE 15 GM/BOTTLE | 11P-0913 KVK-TECH, INC. | POWDER | Approved | 1/28/2013 |
| KETAMINE HYDROCHLORIDE 100 MG/ML-10ML VIALS | 01P-0156/CP1 BIONICHE PHARMA GROUP | INJECTION | Approved | 8/20/2001 |
| KETOCONAZOLE 20 MG/ML | 85P-0147/CP JANSSEN | ORAL SUSPENSION | Withdrawn | 3/26/2007 |
| KETOPROFEN; 12.5 MG HYDROCODONE BITARTRATE 7.5 MG | 03P-0453/CP1 KING & SPALDING LLP | TABLET | Denied | 3/15/2006 |
| KETOROLAC TROMETHAMINE 30 MG/ML - 5 ML | 99P-0510/CP1 APOTEX CORP. | INJECTABLE; INJECTION | Approved | 9/16/1999 |
| LACTATED RINGERS 3000 ML | 11P-0550 B. BRAUN MEDICAL | INJECTION | Withdrawn | 8/16/2012 |
| LACTULOSE 10 G, 20 G | 96P-0155/CP1 BENNETT AND COMPANY | POWDER FOR ORAL SOLUTION (EFFERVESCENT) | Withdrawn | 4/24/2000 |
| LACTULOSE 10 GRAMS & 20 GRAMS | 12P-0496 CUMBERLAND PHARMACEUTICALS | POWDER FOR ORAL SOLUTION | Withdrawn | 4/9/2013 |
| LACTULOSE CRYSTALS | 10P-0398 BENNETT AND COMPANY | LIQUID; ORAL | Withdrawn | 1/6/2012 |
| LAMOTRIGINE 50 MG; 250 MG | 05P-0212/CP1 PHARMACEUTICAL PATENT ATTORNEY | TABLETS | Withdrawn | 7/1/2005 |
| LEUCOVORIN CALCIUM 1 MG/ML | 88P-0149/CP ROXANE | ORAL SOLUTION | Withdrawn | 3/26/2007 |
| LEUCOVORIN CALCIUM 10 MG/ML 350 MG VIAL | 94P-0433/CP1 LEDERLE LABORATORIES | INJECTABLE; INJECTION | Withdrawn | 3/26/2007 |
| LEUCOVORIN CALCIUM 10 MG/ML 5 ML VIAL | 94P-0433/CP2 LEDERLE LABORATORIES | INJECTABLE; INJECTION | Withdrawn | 3/26/2007 |
| LEUCOVORIN CALCIUM 5 MG/ML - 100ML VIAL | 00P-1518/CP1 PD REGULATORY SERVICES | INJECTION | Withdrawn | 2/14/2001 |
| LEVETIRACETAM 1000 MG, 1500 MG | 09P-0285/CP THE WEINBERG GROUP | TABLET; EXTENDED-RELEASE; ORAL | Approved | 9/7/2010 |
| LEVETIRACETAM 1000 MG/VIAL | 11P-0186 NEXUS PHARMACEUTICALS | INJECTION | Pending | 3/29/2011 |
| LEVOCARNITINE 200 MG/ML - 12.5 ML | 99P-0553/CP1 GENSIA SICOR PHARMACEUTICALS | INJECTABLE; INJECTION | Approved | 9/16/1999 |
| LEVOLEUCOVORIN CALCIUM 50 MG/5 ML | 11P-0821 LACHMAN CONSULTANT SERVICES | INJECTION | Pending | 11/17/2011 |
| LEVOMETHADYL ACETATE HCL 10 MG, 20 MG, 40 MG | 07P-0403/CP1 VCU SCHOOL OF MEDICINE | TABLETS | Pending | 10/23/2007 |
| LEVONORGESTREL 1.5 MG | 03P-0216/CP1 HRA PHARMA | TABLET | Denied | 12/17/2003 |
| LEVORPHANOL TARTRATE 1 mg, 3 mg | 02P-0225/CP1 LACHMAN CONSULTANT SERVICES | TABLETS | Approved | 10/16/2002 |
| LIDOCAINE 10 MG | 08P-0001/CP1 ODAN LABORATORIES | ORAL SPRAY NON-AEROSOL | Pending | 1/7/2007 |
| LIDOCAINE 5% | 01P-0291/CP1 Ferndale Laboratories Inc. | CREAM; TOPICAL | Denied | 7/3/2002 |
| LIDOCAINE HYDROCHLORIDE 12 MG | 06P-0230/CP1 ODAN LABORATORIES | ORAL NON-AEROSOL SPRAY | Pending | 6/15/2006 |
| LIDOCAINE HYDROCHLORIDE 2% | 05P-0243/CP1 INT. INST. FOR CLIN. RESEARCH | TOPICAL (SPRAY) | Pending | 1/17/2006 |
| LIDOCAINE HYDROCHLORIDE 20 MG/ML EPINEPHRINE BITARTRATE 0.01 MG/ML | 10P-0072 ARENT FOX | INJECTION | Withdrawn | 3/22/2010 |
| LOPERAMIDE HYDROCHLORIDE 1 MG | 93P-0332/CP1 ELLIS PHARM | EFFERVESCENT TABLET | Withdrawn | 3/26/2007 |
| LOPERAMIDE HYDROCHLORIDE 1 MG | 02P-0424/CP1 BANNER PHARMACAPS | CAPSULE; ORAL | Withdrawn | 7/7/2007 |
| LOPERAMIDE HYDROCHLORIDE 2 MG | 87P-0268/CP KROSS | TABLET | Withdrawn | 3/26/2007 |
| LOPERAMIDE HYDROCHLORIDE 2 mg | 02P-0380/CP1 BANNER PHARMACAPS | SOFT GELATIN CAPSULES | Withdrawn | 6/7/2007 |
| LOPERAMIDE HYDROCHLORIDE 2 MG | 06P-0253/CP1 AAC CONSULTING | ORALLY DISSOLVING STRIP | Pending | 7/5/2006 |
| LOPERAMIDE HYDROCHLORIDE 2 MG | 06P-0305/CP1 MONOSOL RX | ORALLY DISSOLVING STRIPS | Pending | 8/10/2006 |
| LOPERAMIDE HYDROCHLORIDE 2 MG | 06P-0098/CP1 MONOSOL RX | ORALLY DISSOLVING STRIP | Withdrawn | 5/10/2006 |
| LOPINAVIR 100 MG RITONAVIR 25 MG | 07P-0437/CP1 MATRIX LABORATORIES | TABLETS | Pending | 11/13/2007 |
| LORATADINE 10 MG | 06P-0208/CP1 STRIDES | CAPSULES, SOFT GELATIN | Pending | 2/1/2010 |
| LORATADINE 5 MG, 10 MG | 07P-0037/CP1 LACHMAN CONSULTANT SERVICES | ORALLY-DISSOLVING STRIPS | Pending | 2/6/2007 |
| LORAZEPAM 0.5 MG, 1 MG OR 2 MG | 85P-0515/CP WYETH | TABLET (FAST-DISSOLVING) | Withdrawn | 3/26/2007 |
| LORAZEPAM 0.5 MG, 1 MG, 2 MG | 87P-0037/CP APPLIED LABS | SOFT GELATIN CAPSULE | Withdrawn | 3/26/2007 |
| LORAZEPAM 1 MG/5 ML | 86P-0292/CP ROXANE | ORAL SOLUTION | Withdrawn | 3/26/2007 |
| LOSARTAN POTASSIUM 10 MG/ML | 05P-0351/CP1 MORTON GROVE | ORAL SOLUTION | Denied | 9/25/2007 |
| MAGNESIUM SULFATE 20 ML AND 50 ML | 09P-0091/CP1 APP PHARMACEUTICALS | INJECTION | Withdrawn | 2/26/2009 |
| MAGNESIUM SULFATE 50 ML | 12P-1004 SHEPPARD MULLIN | INJECTION | Withdrawn | 11/9/2012 |
| MAGNESIUM SULFATE 50% 20 ML, 50 ML FIL | 09P-0397 OLSSON FRANK WEEDA | INJECTION | Approved | 9/7/2010 |
| MEFENAMIC ACID 250 MG | 97P-0155/CP1 PITNEY, HARDIN, KIPP AND SZUCH | TABLET; ORAL | Withdrawn | 3/26/2007 |
| MEFENAMIC ACID 500 MG | 12P-1058 LACHMAN CONSULTANT SERVICES | CAPSULES | Pending | 10/23/2012 |
| MELOXICAM 7.5MG, 15MG | 05P-0480/CP1 CAMARGO PHARMACEUTICAL SERVICE | ORALLY DISINTEGRATING TABLETS | Pending | 12/5/2005 |
| MEMANTINE HYDROCHLORIDE 5 MG, 10 MG | 07P-0203/CP1 ORGENUS PHARMA | ORALLY DISINTEGRATING TABLETS | Approved | 3/7/2011 |
| MEPERIDINE HYDROCHLORIDE 75 MG, 150 MG | 04P-0500/CP1 LACHMAN CONSULTANT SERVICES | TABLETS | Approved | 3/31/2005 |
| MERCAPTOPURINE 100 MG | 00P-1645/CP1 McKENNA & CUNEO | TABLET; ORAL | Approved | 4/17/2001 |
| MERCAPTOPURINE 25 MG | 10P-0582 LACHMAN CONSULTANT SERVICES | TABLET | Approved | 3/27/2012 |
| METFORMIN HYDROCHLORIDE 1000 MG | 03P-0388/CP1 LACHMAN CONSULTANT SERVICES | EXTENDED RELEASE TABLETS | Approved | 12/23/2003 |
| METFORMIN HYDROCHLORIDE 500 MG, 850 MG 1 GM | 10P-0533 ZYDUS PHARMACEUTICALS | POWDER FOR SOLUTION | Approved | 9/27/2012 |
| METFORMIN HYDROCHLORIDE 500 MG, 850 MG, 1 G | 11P-0558 LACHMAN CONSULTANT SERVICES | CHEWABLE TABLETS | Approved | 9/27/2012 |
| METFORMIN HYDROCHLORIDE 500mg, 850mg, 1000mg | 02P-0499/CP1 THE WEINBERG GROUP | TABLETS FOR ORAL SOLUTION | Approved | 2/11/2004 |
| METHACHOLINE CHLORIDE 1280 MG/VIAL | 04P-0359/CP1 METHAPHARM | ORAL INHALATION | Withdrawn | 3/21/2006 |
| METHACHOLINE CHLORIDE 1280 MG/VIAL | 04P-0511/CP1 ACIC FINE CHEMICALS, INC. | POWDER, METERED | Withdrawn | 3/21/2006 |
| METHADONE HYDROCHLORIDE 15mg, 20mg, 30mg | 02P-0481/CP1 LACHMAN CONSULTANT SERVICES | TABLETS (DISPERSIBLE) | Approved | 3/4/2003 |
| METHADONE HYDROCHLORIDE 15MG,20MG,30MG,40MG | 03P-0119/CP1 LACHMAN CONSULTANT SERVICES | TABLETS USP | Pending | 5/13/2003 |
| METHADONE HYDROCHLORIDE 15MG,20MG,30MG,40MG | 01P-0377/CP1 LACHMAN CONSULTANT SERVICES IN | TABLET; ORAL | Withdrawn | 11/11/2002 |
| METHIMAZOLE 15 MG AND 20 MG | 00P-1308/CP1 LACHMAN CONSULTANT SERVICES | TABLET; ORAL | Approved | 9/9/2000 |
| METHOCARBAMOL 1000 MG | 06P-0002/CP1 LACHMAN CONSULTANT SERVICES | TABLETS | Approved | 12/3/2010 |
| METHOTREXATE 100 MG/ML | 06P-0177/CP1 SICOR PHARMACEUTICALS | INJECTION | Withdrawn | 3/23/2007 |
| METHOTREXATE 1000 MG/ML 10 ML VIAL | 06P-0507/CP1 SICOR PHARMACEUTICALS | INJECTION | Pending | 1/11/2007 |
| METHOTREXATE DISODIUM 2.5 MG/ML | 99P-2078/CP1 MCKENNA & CUNEO, L.L.P. | FOR ORAL SOLUTION | Withdrawn | 10/18/1999 |
| METHOTREXATE SODIUM 2.5 MG/ML | 99P-2078/CP2 MCKENNA & CUNEO, L.L.P. | FOR ORAL SOLUTION | Withdrawn | 3/29/2000 |
| METHOTREXATE SODIUM 5 mg/mL | 02P-0226/CP1 KIRKPATRICK & LOCKHART LLP | ORAL SOLUTION | Withdrawn | 2/3/2004 |
| METHYLPHENIDATE HYDROCHLORIDE 2.5 MG | 99P-1418/CP1 LACHMAN CONSULTANT SERVICES | TABLET; ORAL | Denied | 2/29/2000 |
| METHYLPHENIDATE HYDROCHLORIDE 5 MG & 10 MG | 99P-1417/CP1 LACHMAN CONSULTANT SERVICES | TABLET; CHEWABLE | Denied | 2/29/2000 |
| METHYLPHENIDATE HYDROCHLORIDE 5 MG/5 ML 10 MG/5 ML | 99P-1416/CP1 LACHMAN CONSULTANT SERVICES | SOLUTION; ORAL | Denied | 2/29/2000 |
| METHYLPHENIDATE HYDROCHLORIDE 72 MG | 05P-0257/CP1 THE WEINBERG GROUP | TABLET; EXTENDED-RELEASE; ORAL | Approved | 11/14/2005 |
| METHYLPREDNISOLONE 16 MG 24 MG | 94P-0432/CP1 DURA PHARMACEUTICALS | TABLET; CHEWABLE | Withdrawn | 3/26/2007 |
| METHYLPREDNISOLONE 4 MG & 16 MG | 98P-0911/CP1 RICHARD HAMER ASSOCIATES, INC. | TABLET; SUBLINGUAL | Denied | 6/14/1999 |
| METHYLTESTOSTERONE 25 MG | 85P-0067/CP STAR PHARMS | CAPSULE | Withdrawn | 3/26/2007 |
| METHYLTESTOSTERONE 25 MG | 93P-0459/CP1 ICN | CAPSULE | Withdrawn | 3/26/2007 |
| METOCLOPRAMIDE HYDROCHLORIDE 5 MG, 10 MG | 04P-0409/CP1 LACHMAN CONSULTANT SERVICES | ORALLY DISINTEGRATING TABLETS | Withdrawn | 10/17/2005 |
| METOPROLOL SUCCINATE 12.5 MG | 12P-0698 LACHMAN CONSULTANT SERVICES | TABLET; EXTENDED-RELEASE; ORAL | Pending | 7/5/2012 |
| METOPROLOL TARTRATE 12.5 MG | 06P-0395/CP1 KENDLE INTERNATIONAL | TABLETS | Withdrawn | 8/27/2008 |
| METOPROLOL TARTRATE 12.5 MG | 03P-0441/CP1 NABEAL M. SAIF | TABLETS | Denied | 10/15/2004 |
| METOPROLOL TARTRATE 25 mg | 02P-0460/CP1 CARACO PHARMACEUTICAL | TABLETS | Approved | 2/13/2003 |
| METOPROLOL TARTRATE 25 mg | 02P-0459/CP1 LACHMAN CONSULTANT SERVICES | TABLETS | Approved | 2/13/2003 |
| METOPROLOL TARTRATE 37.5 MG, 75 MG | 07P-0072/CP1 LACHMAN CONSULTANT SERVICES | TABLETS | Approved | 3/18/2010 |
| METRONIDAZOLE 0.75% | 95P-0328/CP1 RNB PHARMACEUTICAL COMPANY | LOTION; TOPICAL | Withdrawn | 3/26/2007 |
| METRONIDAZOLE 50 MG | 09P-0121/CP1 PHARMENG TECHNOLOGY INC. | TABLETS | Pending | 3/4/2009 |
| MIDAZOLAM 5 MG/ML-10 ML VIALS | 01P-0136/CP1 ABBOTT LABORATORIES | INJECTION | Approved | 8/5/2002 |
| MIDAZOLAM HYDROCHLORIDE 500 MG/100 ML | 10P-0460 ALAUNUS | INJECTION | Approved | 7/7/2012 |
| MIDODRINE HYDROCHLORIDE 15 MG | 01P-0081/CP1 LACHMAN CONSULTANT SERVICES | TABLET; ORAL | Approved | 5/8/2001 |
| MINOCYCLINE HYDROCHLORIDE 70 MG, 95 MG | 11P-0347 LACHMAN CONSULTANT SERVICES | TABLET; EXTENDED-RELEASE; ORAL | Approved | 1/28/2013 |
| MINOCYCLINE HYDROCHLORIDE 70 MG, 95 MG | 11P-0347/PRC MEDICIS | TABLET; EXTENDED-RELEASE; ORAL | Pending | 3/26/2013 |
| MINOXIDIL 2%, 5% W/W | 08P-0643/CP1 BAKER & HOSTETLER | CREAM; TOPICAL | Pending | 12/18/2008 |
| MIRTAZAPINE 7.5 mg | 02P-0249/CP1 AAC CONSULTING GROUP | TABLETS | Approved | 2/27/2003 |
| MORPHINE SULFATE 15MG,60MG,90MG,100MG | 93P-0446/CP1 ETHYPHARM | EXTENDED-RELEASE CAPSULE | Withdrawn | 3/26/2007 |
| MORPHINE SULFATE 20 MG/ML | 09P-0388 MERCHANT & GOULD | SOLUTION (CONCENTRATE) | Pending | 8/19/2009 |
| MORPHINE SULFATE 200 MG | 97P-0225/CP1 ETHYPHARM | CAPSULE, EXTENDED RELEASE; ORAL | Approved | 4/14/2000 |
| MORPHINE SULFATE 25 MG/ML 50 ML & 100 ML VIALS | 10P-0012 ALAUNUS PHARMACEUTICAL LLC | INJECTION | Withdrawn | 12/29/2011 |
| MORPHINE SULFATE 30 MG | 89P-0071/CP OXFORD RES INTL | EXTENDED-RELEASE CAPSULE | Withdrawn | 3/26/2007 |
| MORPHINE SULFATE 5 MG, 10 MG, 20 MG | 08P-0401/CP1 RAKOCZY MOLINO MAZZOCHI SIWIK | TABLETS | Pending | 7/17/2008 |
| MORPHINE SULFATE 5 MG/ML | 12P-1251 GORDON JOHNSTON REGULATORY CON | INJECTION | Pending | 1/8/2013 |
| MULTIVITAMIN SINGLE DOSE PHARMACY BULK PKG | 09P-0417 STRIDES | FOR INJECTION | Withdrawn | 11/15/2010 |
| NABUMETONE 1000 MG | 07P-0275/CP1 LACHMAN CONSULTANT SERVICES | TABLETS | Approved | 3/18/2010 |
| NAFCILLIN SODIUM 200 GRAM | 03P-0184/CP1 SAMSON MEDICAL TECHNOLOGIES | INJECTION | Approved | 8/18/2003 |
| NALTREXONE HYDROCHLORIDE 25MG, 100MG & 150MG | 99P-4775/CP1 LACHMAN CONSULTANT SERVICES | TABLET; ORAL | Approved | 4/13/2000 |
| NAPROXEN SODIUM 220 mg | 02P-0473/CP1 BANNER PHARMACAPS | SOFT GELATIN CAPSULES | Withdrawn | 4/13/2005 |
| NIACIN 375 MG, 500 MG | 08P-0340/CP1 LUPIN PHARMACEUTICALS | CAPSULE, EXTENDED RELEASE | Pending | 6/18/2008 |
| NICOTINE BASE 2 MG/240 ML 4 MG/240 ML | 04P-0281/CP1 NICO WORLDWIDE, LLC | ORAL SOLUTION | Denied | 10/29/2010 |
| NICOTINE BITARTRATE 2 MG/240 ML 4 MG/240 ML | 04P-0282/CP1 NICO WORLDWIDE, LLC | ORAL SOLUTION | Denied | 10/29/2010 |
| NICOTINE POLACRILEX 2 MG/240 ML 4 MG/240 ML | 04P-0280/CP1 NICO WORLDWIDE, LLC | ORAL SOLUTION | Denied | 5/26/2005 |
| NIFEDIPINE 10 MG OR 20 MG | 87P-0340/CP PAR | TABLET | Withdrawn | 3/26/2007 |
| NIFEDIPINE 30 MG, 60 MG, 90 MG | 90P-0436/CP1 KV | EXTENDED-RELEASE CAPSULE | Withdrawn | 3/26/2007 |
| NIFEDIPINE 30 MG, 60 MG, 90 MG | 95P-0326/CP1 KV PHARMACEUTICAL | CAPSULE, EXTENDED RELEASE; ORAL | Withdrawn | 3/26/2007 |
| NIZATIDINE 75 MG | 00P-1245/CP1 LACHMAN CONSULTANT SERVICES | CAPSULE; ORAL | Approved | 4/17/2001 |
| OLSALAZINE SODIUM 500 MG | 08P-0422/CP1 LACHMAN CONSULTANT SERVICES | CAPSULES | Approved | 3/18/2010 |
| OMEPRAZOLE 10 MG, 20 MG | 98P-0225/CP1 ANDRX PHARMACEUTICALS INC. | TABLET; DELAYED RELEASE; ORAL | Denied | 9/16/1999 |
| OMEPRAZOLE 20 MG | 06P-0117/CP1 QPHARMA, LLC | DELAYED-RELEASE TABLET; ORAL | Pending | 3/15/2006 |
| OMEPRAZOLE 40 MG | 99P-1087/CP1 ANDRX PHARMACEUTICALS, INC. | TABLET; DELAYED-RELEASE, ORAL | Approved | 4/18/2000 |
| OMEPRAZOLE MAGNESIUM 20 MG BASE | 04P-0373/CP1 GRAY CARY | DELAYED RELEASE CAPSULE | Approved | 7/5/2005 |
| ONDANSETRON 16 MG, 24 MG | 04P-0056/CP1 LACHMAN CONSULTANT SERVICES | ORALLY DISINTEGRATING TABLETS | Approved | 7/7/2004 |
| ONDANSETRON 16 MG/25 ML | 12P-1068 BEN VENUE | INJECTION | Withdrawn | 2/15/2013 |
| ONDANSETRON 4 MG, 8 MG | 11P-0166 LACHMAN CONSULTANT SERVICES | EFFERVESCENT TABLETS | Denied | 6/19/2012 |
| ONDANSETRON 4 MG, 8 MG 16 MG, 24 MG | 07P-0043/CP1 LACHMAN CONSULTANT SERVICES | ORALLY DISSOLVING STRIPS | Withdrawn | 4/30/2009 |
| ONDANSETRON HYDROCHLORIDE 16 MG | 01P-0492/CP1 MCDERMOTT, WILL & EMERY | TABLET; ORAL | Approved | 4/12/2002 |
| ONDANSETRON HYDROCHLORIDE 8 MG/4 ML | 04P-0544/CP1 OLSSON, FRANK AND WEEDA | INJECTION | Denied | 6/19/2012 |
| ONDANSETRON HYDROCHLORIDE 8 MG/4 ML | 04P-0048/CP1 ABBOTT LABORATORIES | INJECTION | Withdrawn | 4/12/2004 |
| ONDANSETRON HYDROCHLORIDE 8, 12, 16, 20, 24MG IN 50 ML 5% DEXTROSE | 03P-0519/CP1 ABBOTT LABORATORIES | INJECTION | Withdrawn | 4/12/2004 |
| OXALIPLATIN 200 MG/VIAL | 07P-0450/CP1 EBEWE PARENTA PHARMACEUTICALS | INJECTION | Approved | 9/1/2010 |
| OXAZEPAM 15 MG OR 30 MG | 85P-0516/CP WYETH | TABLET | Withdrawn | 3/26/2007 |
| OXYCODONE 2.5 MG, 5 MG ACETAMINOPHEN 325 MG | 06P-0167/CP1 ARNALL GOLDEN GREGORY | ORALLY DISINTEGRATING TABLET | Pending | 4/26/2006 |
| OXYCODONE 2.5, 5, 7.5, 10 MG ACETAMINOPHEN 400 MG | 04P-0243/CP1 LACHMAN CONSULTANT SERVICES | TABLETS | Withdrawn | 6/10/2004 |
| OXYCODONE 5mg, 7.5mg, 10mg ACETAMINOPHEN 300mg | 02P-0105/CP1 LACHMAN CONSULTANT SERVICES | TABLETS | Approved | 8/6/2002 |
| OXYCODONE 7.5 MG, 10 MG ACETAMINOPHEN 325 MG | 06P-0167/CP2 ARNALL GOLDEN GREGORY | ORALLY DISINTEGRATING TABLET | Pending | 4/26/2006 |
| OXYCODONE HYDROCHLORIDE 10 MG/5 ML ACETAMINOPHEN 300 MG/5 ML | 06P-0007/CP1 LACHMAN CONSULTANT SERVICES | ORAL SOLUTION | Approved | 1/16/2007 |
| OXYCODONE HYDROCHLORIDE 10,15, 20, 30 MG 40, 60, 80 MG | 12P-1180 LANNETT | CAPSULE, EXTENDED RELEASE; ORAL | Pending | 12/18/2012 |
| OXYCODONE HYDROCHLORIDE 15 MG, 20 MG ACETAMINOPHEN 325 MG | 02P-0285/PRC1 KING & SPALDING | TABLETS | Denied | 7/30/2004 |
| OXYCODONE HYDROCHLORIDE 15 mg, 20 mg ACETAMINOPHEN 325 mg | 02P-0285/CP1 KING & SPALDING | TABLETS | Denied | 2/12/2003 |
| OXYCODONE HYDROCHLORIDE 15 MG, 20 MG ACETAMINOPHEN 325MG, 325 MG | 02P-0285/PRC1 KING & SPALDING | TABLET; ORAL | Denied | 7/30/2004 |
| OXYCODONE HYDROCHLORIDE 2.5 mg ACETAMINOPHEN 300 mg | 02P-0465/CP1 LACHMAN CONSULTANT SERVICES | TABLETS | Approved | 2/13/2003 |
| OXYCODONE HYDROCHLORIDE 2.5 MG | 09P-0399 REGULUS PHARMACEUTICAL CONSULT | TABLETS | Approved | 11/16/2010 |
| OXYCODONE HYDROCHLORIDE 2.5 MG, 5 MG ACETAMINOPHEN 325 MG | 04P-0149/CP1 ENDO PHARMACEUTICALS | ORALLY DISINTEGRATING TABLETS | Withdrawn | 5/4/2006 |
| OXYCODONE HYDROCHLORIDE 2.5, 5, 7.5 10 MG ACETAMINOPHEN 650 MG | 09P-0203-0003 LACHMAN CONSULTANT SERVICES | TABLETS; EFFERVESCENT | Withdrawn | 3/23/2011 |
| OXYCODONE HYDROCHLORIDE 2.5, 5, 7.5, 10 MG ACETAMINOPHEN 500 MG | 09P-0203-0001 LACHMAN CONSULTANT SERVICES | TABLETS; EFFERVESCENT | Withdrawn | 3/23/2011 |
| OXYCODONE HYDROCHLORIDE 20 MG/ML | 05P-0144/CP1 THE WEINBERG GROUP | ORAL SOLUTION | Denied | 3/28/2006 |
| OXYCODONE HYDROCHLORIDE 30 MG, 60 MG | 05P-0225/CP1 THE WEINBERG GROUP | TABLET; CONTROLLED-RELEASE; ORAL | Approved | 7/15/2005 |
| OXYCODONE HYDROCHLORIDE 5 MG | 06P-0481/CP1 ACTAVIS TOTOWA | CAPSULES | Pending | 12/11/2006 |
| OXYCODONE HYDROCHLORIDE 5 MG | 08P-0598/CP1 VINTAGE PHARMACEUTICALS | CAPSULES | Withdrawn | 5/7/2012 |
| OXYCODONE HYDROCHLORIDE 5 MG, 10 MG, 20 MG | 04P-0148/CP1 THE WEINBERG GROUP | TABLETS | Approved | 9/28/2004 |
| OXYCODONE HYDROCHLORIDE 5, 10, 15, 20, 30 MG | 04P-0153/CP1 THE WEINBERG GROUP | CAPSULES | Denied | 5/17/2005 |
| OXYCODONE HYDROCHLORIDE 7.5 MG | 05P-0140/CP1 LACHMAN CONSULTANT SERVICES | TABLETS | Approved | 7/14/2005 |
| OXYCODONE HYDROCHLORIDE 7.5 MG, 10.0 MG ACETAMINOPHEN 325 MG | 04P-0150/CP1 ENDO PHARMACEUTICALS | ORALLY DISINTEGRATING TABLETS | Withdrawn | 5/4/2006 |
| OXYCODONE HYDROCHLORIDE 9.25 MG, AND 7.0 MG OXYCODONE TEREPHTHALATE 0.85 MG, AND 0.57 MG | 99P-5105/CP1 KING & SPALDING | TABLET; ORAL | Denied | 5/7/2001 |
| OXYTOCIN 1000 USP UNITS/100ML | 10P-0112 ALAUNUS PHARMACEUTICAL LLC | INJECTION | Pending | 3/2/2010 |
| PAMIDRONATE DISODIUM 3 MG/ML, 10 ML 9 MG/ML, 10 ML | 99P-1653/CP1 MITCHELL G. CLARK | INJECTION | Withdrawn | 10/14/1999 |
| PAMIDRONATE DISODIUM 3mg/mL - 10 mL 6mg/mL - 10 mL | 99P-2252/CP1 FAULDING PHARMACEUTICAL CO. | INJECTION | Approved | 4/18/2000 |
| PAMIDRONATE DISODIUM 3MG/ML - 10 ML VIALS 9MG/ML - 10 ML VIALS | 00P-0091/CP1 MITCHALL G. CLARK | INJECTION | Approved | 4/18/2000 |
| PAROXETINE 20 MG & 40 MG | 01P-0241/CP1 CIPHER PHARMACEUTICALS LTD. | CAPSULE; ORAL | Withdrawn | 2/12/2004 |
| PEMETREXED 1000 MG | 11P-0052 LACHMAN CONSULTANT SERVICES | INJECTION | Approved | 3/27/2012 |
| PEMETREXED DISODIUM 750 MG/VIAL | 12P-1259 HYMAN PHELPS & MCNAMARA | INJECTION | Pending | 1/8/2013 |
| PENICILLAMINE 500 MG | 08P-0463/CP1 LACHMAN CONSULTANT SERVICES | CAPSULES | Approved | 3/18/2010 |
| PENTAMIDINE ISETHIONATE 100 MG/ML | 89P-0435/CP ASTRA | INJECTION | Withdrawn | 3/26/2007 |
| PENTAZOCINE HYDROCHLORIDE 12.5 MG, 25 MG ACETAMINOPHEN 325 MG | 11P-0459 LACHMAN CONSULTANT SERVICES | TABLETS | Pending | 6/15/2011 |
| PENTETATE ZINC TRISODIUM 1055 MG/5 ML | 09P-0258/CP HEYL CHEMISCH | INJECTION; SOLUTION | Pending | 6/9/2009 |
| PENTOXIFYLLINE 500 MG | 01P-0283/CP1 THE WEINBERG GROUP, INC. | TABLET; EXTENDED-RELEASE; ORAL | Denied | 7/3/2002 |
| PENTOXYFYLLINE 400 MG | 96P-0079/CP1 KV PHARMACEUTICAL COMPANY | EXTENDED-RELEASE PACKET (MICROPARTICLE) | Withdrawn | 3/26/2007 |
| PHENYTOIN SODIUM 100 MG; 250 MG/VIAL | 87P-0367/CP LYPHOMED | FOR INJECTION | Withdrawn | 3/26/2007 |
| PHENYTOIN SODIUM 200 MG, 300 MG | 00P-1462/CP1 LACHMAN CONSULTANT SERVICES | CAPSULE, EXTENDED RELEASE; ORAL | Approved | 2/13/2000 |
| PHYTONADIONE 2.5 MG,7.5 MG, 10 MG | 08P-0421/CP1 LACHMAN CONSULTANT SERVICES | TABLETS | Approved | 3/18/2010 |
| PIPERACILLIN 12 GRAMS TAZOBACTAM 1.5 GRAMS | 06P-0095/CP1 SANDOZ | INJECTION | Approved | 5/6/2011 |
| PIPERACILLIN SODIUM 300 & 360 GRAMS TAZOBACTAM SODIUM 37.5 & 45 GRAMS | 11P-0031 SAMSON MEDICAL | INJECTION | Pending | 1/14/2011 |
| POTASSIUM ACETATE 100 ML/100 CC PBP | 09P-0068/CP1 APP PHARMACEUTICALS | INJECTION | Approved | 6/22/2011 |
| POTASSIUM ACETATE 200 MEQ | 12P-0983 SHEPPARD MULLIN | INJECTION | Withdrawn | 11/9/2012 |
| POTASSIUM ACETATE 50 ML | 09P-0102/CP1 APP PHARMACEUTICALS | INJECTION | Pending | 2/26/2009 |
| POTASSIUM ACETATE 50 ML | 09P-0108/CP1 APP PHARMACEUTICALS | INJECTION | Approved | 6/22/2011 |
| POTASSIUM CHLORIDE 10 mEq | 96P-0054/CP1 KV PHARMACEUTICAL COMPANY | FOR ORAL SUSPENSION EXTENDED-RELEASE | Withdrawn | 3/26/2007 |
| POTASSIUM CHLORIDE 10%, 20% | 06P-0477/CP1 KING & SPALDING | ORAL SOLUTION | Pending | 12/11/2006 |
| POTASSIUM CHLORIDE 15 mEq | 01P-0108/CP1 LACHMAN CONSULTANTS | TABLET; EXTENDED-RELEASE; ORAL | Approved | 7/9/2001 |
| POTASSIUM CHLORIDE 20 mEq | 96P-0018/CP1 KV PHARMACEUTICAL | EXTENDED-RELEASE CAPSULES | Withdrawn | 3/26/2007 |
| POTASSIUM IODIDE 65 MG | 00P-1574/CP1 R&R REGISTRATIONS | TABLET; ORAL | Approved | 7/25/2001 |
| POTASSIUM IODIDE 65 MG/ML | 04P-0092/CP1 RRD INTERNATIONAL | ORAL SOLUTION | Approved | 3/3/2004 |
| POTASSIUM PHOSPHATES 5 ML/10 CC 15 ML/30 CC | 09P-0082/CP1 APP PHARMACEUTICALS | INJECTION | Withdrawn | 3/10/2009 |
| PRAVASTATIN SODIUM 30 MG | 04P-0216/CP1 LACHMAN CONSULTANT SERVICES | TABLETS | Approved | 9/28/2004 |
| PRAVASTATIN SODIUM 60 MG | 04P-0213/CP1 LACHMAN CONSULTANT SERVICES | TABLETS | Approved | 9/28/2004 |
| PREDNISOLONE 10 MG, 15 MG, 30 MG | 09P-0180/CP1 LACHMAN CONSULTANT SERVICES | TABLETS | Approved | 10/6/2010 |
| PREDNISOLONE SODIUM PHOSPHATE 10 MG (BASE) | 96P-0498/CP1 WE PHARMACEUTICALS, INC. | TABLET; CHEWABLE | Withdrawn | 4/5/2000 |
| PREDNISOLONE SODIUM PHOSPHATE 10 MG/5 ML | 06P-0072/CP1 OLSSON, FRANK AND WEEDA | ORAL SOLUTION | Withdrawn | 4/11/2006 |
| PREDNISOLONE SODIUM PHOSPHATE 10MG/5ML; 20MG/5ML; 25MG/5ML | 05P-0080/CP1 LACHMAN CONSULTANT SERVICES | SOLUTION | Approved | 4/8/2005 |
| PREDNISOLONE SODIUM PHOSPHATE 15 MG/5 ML | 96P-0499/CP1 WE PHARMACEUTICALS, INC. | LIQUID; ORAL | Withdrawn | 4/5/2000 |
| PREDNISOLONE SODIUM PHOSPHATE 30 MG/5ML | 08P-0584/CP1 COHEN TAUBER SPIEVACK & WAGNER | SOLUTION | Approved | 5/6/2011 |
| PREDNISONE 1,2.5,20,50 MG | 93P-0333/CP1 DURA PHARMS | CHEWABLE TABLET | Withdrawn | 3/26/2007 |
| PREDNISONE 1,2.5,5,10,20,25,50 | 88P-0391/CP ASCHER | CAPSULE | Withdrawn | 3/26/2007 |
| PREDNISONE 5 MG OR 10 MG | 92P-0336/CP1 WE PHARMS | CHEWABLE TABLET | Withdrawn | 3/26/2007 |
| PRIMIDONE 25 MG,100 MG, 125 MG | 09P-0482 LACHMAN CONSULTANT SERVICES | TABLETS | Approved | 11/15/2012 |
| PRIMIDONE 50, 100, 125, 250 MG | 09P-0481 LACHMAN CONSULTANT SERVICES | TABLETS ORALLY DISINTEGRATING | Approved | 1/16/2013 |
| PRIMIDONE 50, 100, 125, 250 MG | 09P-0477 LACHMAN CONSULTANT SERVICES | CAPSULES | Approved | 1/16/2013 |
| PROGESTERONE 100 MG & 200 MG | 01P-0209/CP1 DURAMED | TABLET; ORAL | Approved | 7/3/2002 |
| PROMETHAZINE HYDROCHLORIDE 25 MG, 50 MG | 09P-0249/CP LACHMAN CONSULTANT SERVICES | TABLETS; EFFERVESCENT | Withdrawn | 4/7/2011 |
| PROMETHAZINE HYDROCHLORIDE 6.25 MG HYDROCODONE BITARTRATE 2.5 MG, 1.67 MG | 07P-0076/CP1 SOVEREIGN PHARMACEUTICALS | SYRUP | Pending | 3/15/2007 |
| PROPOFOL 100 MG/10 ML (1%) | 00P-1289/CP1 GENSIA SICOR | INJECTION | Approved | 9/9/2000 |
| PROPOFOL 2%:20MG/ML:10ML,50ML | 00P-1471/CP1 GENSIA SICOR PHARMACEUTICALS | INJECTION | Denied | 4/30/2001 |
| PROPOFOL 2000MG/200 ML | 01P-0430/CP1 GENSIA SICOR | INJECTABLE EMULSION | Pending | |
| PROPOXYPHENE HYDROCHLORIDE 65 MG ACETAMINOPHEN 325 MG | 06P-0510/CP1 LACHMAN CONSULTANTS | TABLETS | Approved | 3/5/2009 |
| PROPOXYPHENE HYDROCHLORIDE 65 mg ACETAMINOPHEN 389 mg | 02P-0297/CP1 LACHMAN CONSULTANT SERVICES | CAPSULES | Approved | 2/3/2004 |
| PROPOXYPHENE NAPSYLATE 100 mg ACETAMINOPHEN 325 mg, 500 mg | 02P-0422/CP1 FROMMER LAWRENCE & HAUG | ORAL TABLETS | Withdrawn | 3/7/2003 |
| PROPOXYPHENE NAPSYLATE 100 MG ACETAMINOPHEN 400 MG | 06P-0503/CP1 LACHMAN CONSULTANT SERVICES | TABLETS | Approved | 3/5/2009 |
| PROPOXYPHENE NAPSYLATE 50 MG, 100 MG ACETAMINOPHEN 300 MG | 06P-0087/CP1 LACHMAN CONSULTANT SERVICES | TABLETS | Approved | 12/18/2008 |
| PROPOXYPHENE NAPSYLATE; 100 MG ACETAMINOPHEN 500 MG | 00P-1551/CP2 ARNALL, GOLDEN & GREGORY | TABLET; ORAL | Approved | 1/16/2001 |
| PROPOXYPHENE NAPSYLATE; 100 mg ACETAMINOPHEN 325 mg | 01P-0186/CP1 ARNALL, GOLDEN & GREGORY | TABLET; ORAL | Approved | 8/20/2001 |
| PROPOXYPHENE NAPSYLATE; 50 MG ACETAMINOPHEN 500 MG | 00P-1551/CP1 ARNALL, GOLDEN & GREGORY | TABLET; ORAL | Approved | 1/16/2001 |
| PROPRANOLOL HYDROCHLORIDE 10, 20, 60, 80, 90MG | 93P-0049/CP1 FLEMINGTON | EFFERVESCENT TABLET | Withdrawn | 3/26/2007 |
| PROPRANOLOL HYDROCHLORIDE 10,20,40,60,80,90 MG | 86P-0045/CP NUTRIPHARM LABS | CAPSULE | Withdrawn | 3/26/2007 |
| PROPRANOLOL HYDROCHLORIDE 160 MG | 85P-0129/CP VEREX | EXTENDED-RELEASE TABLET | Withdrawn | 3/26/2007 |
| PROPRANOLOL HYDROCHLORIDE 40 MG | 92P-0232/CP1 FLEMINGTON | EFFERVESCENT TABLET | Withdrawn | 3/26/2007 |
| PROPRANOLOL HYDROCHLORIDE 40 MG 0R 80 MG/5 ML HYDROCHLOROTHIAZIDE 25 MG/5 ML | 87P-0399/CP BURDITT, BOWLES, ET. AL. | ORAL SOLUTION | Withdrawn | 3/26/2007 |
| PROPRANOLOL HYDROCHLORIDE 60, 80, 120, 160 MG | 03P-0237/CP1 URL MUTUAL | EXTENDED-RELEASE TABLETS | Withdrawn | 2/3/2004 |
| PROPRANOLOL HYDROCHLORIDE 80 MG, 120 MG, 160MG | 85P-0197/CP FOREST PHARMS | EXTENDED-RELEASE TABLET | Withdrawn | 3/26/2007 |
| PYRIDOXINE HYDROCHLORIDE 100 MG/ML, 10 ML FIL | 09P-0185 BIONICHE PHARMA | INJECTION | Approved | 10/6/2010 |
| PYRIDOXINE HYDROCHLORIDE 3 G/30 ML | 10P-0114 MCGUFF PHARMACEUTICALS | INJECTION | Approved | 11/15/2012 |
| QUINIDINE SULFATE 300 MG | 88P-0277/CP ROBINS AH | EXTENDED-RELEASE CAPSULE | Withdrawn | 3/26/2007 |
| RAMIPRIL 1.25 MG, 2.5 MG 5 MG AND 10 MG | 05P-0460/CP1 LACHMAN CONSULTANT SERVICES | TABLETS | Withdrawn | 11/3/2009 |
| RAMIPRIL 1.25, 2.50, 5, 10 MG | 06P-0084/CP1 KING & SPALDING | TABLETS | Withdrawn | 2/1/2010 |
| RAMIPRIL 1.25MG, 2.5MG, 5MG, 10MG | 05P-0472/CP1 PHARMACEUTICAL PATENT ATTORNEY | TABLETS | Pending | 11/28/2005 |
| RAMIPRIL 2.5 MG & 10 MG | 01P-0240/CP1 Cipher Pharmaceuticals Ltd. | CAPSULE; ORAL | Withdrawn | 7/31/2001 |
| RANITIDINE HYDROCHLORIDE 15 MG BASE/ML | 05P-0228/CP1 LACHMAN CONSULTANT SERVICES | SUSPENSION | Withdrawn | 5/24/2006 |
| RIBAVIRIN 200 MG | 02P-0436/CP1 BIOPARTNERS | TABLET | Withdrawn | 9/29/2004 |
| RIBAVIRIN 400 MG, 600 MG | 04P-0196/CP1 FROMMER LAWRENCE & HAUG | TABLETS | Approved | 9/28/2004 |
| RIBAVIRIN USP 500 MG | 05P-0179/CP1 KILPATRICK STOCKTON | TABLETS | Approved | 7/14/2005 |
| RIFAMPIN 50 MG/5 ML 100 MG/5 ML | 08P-0662/CP1 LACHMAN CONSULTANT SERVICES | SUSPENSION; ORAL | Pending | 1/5/2009 |
| RIFAXIMIN 200 MG | 08P-0404/CP1 STRIDES ARCOLAB | CAPSULES | Pending | 7/18/2008 |
| RISPERIDONE 0.25 MG | 05P-0007/CP1 LACHMAN CONSULTANT SERVICES | ORALLY DISINTEGRATING TABLETS | Approved | 3/31/2005 |
| RITONAVIR 100 MG | 07P-0336/CP1 MATRIX LABORATORIES | TABLETS | Pending | 9/10/2007 |
| SELEGILINE HYDROCHLORIDE 5 MG | 04P-0514/CP1 LACHMAN CONSULTANT SERVICES | ORALLY DISINTEGRATING TABLETS | Withdrawn | 1/11/2012 |
| SERTRALINE HYDROCHLORIDE 150 MG, 200 MG | 04P-0125/CP1 LACHMAN CONSULTANT SERVICES | TABLETS | Withdrawn | 4/12/2004 |
| SERTRALINE HYDROCHLORIDE 25MG, 50MG, 100MG | 00P-1468/CP1 LACHMAN CONSULTANT SERVICES | CAPSULE; ORAL | Approved | 7/3/2002 |
| SIMVASTATIN 10 MG & 40 MG | 01P-0242/CP1 Cipher Pharmaceuticals, Ltd. | CAPSULE; ORAL | Withdrawn | 7/31/2001 |
| SITAGLIPTIN 50 MG METFORMIN HYDROCHLORIDE 850 MG | 12P-0826 LACHMAN CONSULTANT SERVICES | TABLET; EXTENDED-RELEASE; ORAL | Pending | 8/2/2012 |
| SODIUM ACETATE 16.4% PBP | 09P-0055/0003 APP PHARMACEUTICALS | INJECTION | Approved | 9/7/2010 |
| SODIUM ACETATE 32.8% PBP | 09P-0055/0001 APP PHARMACEUTICALS | INJECTION | Approved | 10/6/2010 |
| SODIUM ACETATE 4 MEQ/ML | 12P-0982 SHEPPARD MULLIN | INJECTION | Withdrawn | 11/9/2012 |
| SODIUM ACETATE 50 ML SDV | 09P-0109/CP1 APP PHARMACEUTICALS | INJECTION | Approved | 6/22/2011 |
| SODIUM ACETATE 50 ML SDV | 09P-0107/CP1 APP PHARMACEUTICALS | INJECTION | Pending | 3/3/2009 |
| SODIUM BICARBONATE 5 ML | 09P-0085/CP1 APP PHARMACEUTICALS | INJECTION | Approved | 3/30/2011 |
| SODIUM BICARBONATE 8.4% 1 MEQ/ML 10 ML 4.2% 0.5 MEQ/ML 5 ML | 09P-0396 OLSSON FRANK WEEDA | INJECTION | Approved | 10/6/2010 |
| SODIUM CHLORIDE 0.9% | 11P-0846 JUBILANT HOLLISTERSTIER | INJECTION | Pending | 1/10/2012 |
| SODIUM CHLORIDE 0.9% 9 MG/ML | 09P-0565 BAXTER HEALTHCARE | INJECTION | Approved | 5/6/2011 |
| SODIUM CHLORIDE 0.9%, 1 ML SYRINGE | 06P-0302/CP1 BECKLOFF ASSOCIATES | INJECTION | Approved | 8/22/2007 |
| SODIUM CHLORIDE 100 ML | 09P-0104/CP1 APP PHARMACEUTICALS | INJECTION | Withdrawn | 3/10/2011 |
| SODIUM CHLORIDE 100 ML/100 CC PBP 200 ML/200 CC PBP | 09P-0069/CP1 APP PHARMACEUTICALS | INJECTION | Pending | 2/19/2009 |
| SODIUM CHLORIDE 3 ML, 5 ML, 15 ML, 30 ML | 06P-0272/CP1 BECKLOFF ASSOCIATES | INJECTION | Approved | 8/22/2007 |
| SODIUM FERRIC GLUCONATE 10 ML/125 MG COMPLEX IN SUCROSE | 04P-0360/CP1 AAC CONSULTING | INJECTION | Approved | 3/15/2006 |
| SODIUM FLUORIDE F 18 20-600 mCi/mL | 12P-0103 FEINSTEIN INSTITUTE | INJECTION | Approved | 2/29/2012 |
| SODIUM IODIDE I 131 500 - 3500 MCI/ML | 13P-0219 INTERNATIONAL ISOTOPES | SOLUTION (CONCENTRATE) | Pending | 3/1/2013 |
| SODIUM PHOSPHATES 5 ML/10 CC 50 ML/50 CC | 09P-0080/CP1 APP PHARMACEUTICALS | INJECTION | Approved | 3/30/2011 |
| SODIUM TETRADECYL SULFATE 0.5% & 0.2% | 01P-0351/CP1 Bennett and Company | INJECTION | Denied | 4/12/2002 |
| SPIRONOLACTONE 25 MG/5 ML | 86P-0055/CP CAROLINA MEDCL | ORAL SUSPENSION | Withdrawn | 3/26/2007 |
| SPIRONOLACTONE 25 MG/5 ML | 85P-0510/CP CAROLINA MEDCL | SYRUP | Withdrawn | 3/26/2007 |
| STERILE WATER 2000 ML, 3000 ML | 11P-0551 B. BRAUN MEDICAL | INJECTION | Withdrawn | 8/16/2012 |
| STERILE WATER 5 ML/6 CC VIAL 100 ML/100 CC VIAL | 09P-0070/CP1 APP PHARMACEUTICALS | INJECTION | Approved | 9/7/2010 |
| SULFAMETHOXAZOLE 200 MG TRIMETHOPRIM 40 MG | 94P-0186/CP1 DURA | CHEWABLE TABLET | Withdrawn | 3/26/2007 |
| SULINDAC 200 MG | 08P-0647/CP1 LACHMAN CONSULTANT SERVICES | CAPSULES | Withdrawn | 3/9/2011 |
| TADALAFIL 40 MG | 12P-0935 LACHMAN CONSULTANT SERVICES | TABLETS | Pending | 8/31/2012 |
| TEMAZEPAM 7.5 MG, 15 MG 22.5 MG AND 30 MG | 06P-0103/CP1 LACHMAN CONSULTANT SERVICES | ORALLY DISINTEGRATING TABLETS | Pending | 3/21/2006 |
| TERBUTALINE SULFATE 1 MG/ML 25 ML PHARMACY BULK | 04P-0518/CP1 BEN VENUE | INJECTION | Pending | |
| TERFENADINE 60 MG PSEUDOEPHEDRINE 120 MG | 93P-0367/CP1 EURAND AMERICA | EXTENDED-RELEASE CAPSULE | Withdrawn | 3/26/2007 |
| TESTOSTERONE 5% | 01P-0302/CP1 Testocream LLC | GEL; TOPICAL | Denied | 4/12/2002 |
| THIOTEPA, STERILE 30 MG/VIAL | 00P-0092/CP1 GENSIA SICOR | FOR INJECTION | Approved | 6/14/2000 |
| TOBRAMYCIN 100 MG/ML | 04P-0131/CP1 SOURCE CF | SOLUTION FOR INHALATION | Pending | 3/29/2004 |
| TOPOTECAN 1 MG/ML | 08P-0348/CP1 OLSSON FRANK WEEDA | SOLUTION; INJECTABLE | Withdrawn | 12/3/2009 |
| TOPOTECAN HYDROCHLORIDE 1 MG/1 ML; 3 MG/3 ML 4 MG/4 ML | 08P-0591/CP1 REGULUS PHARMACEUTICAL | SOLUTION | Approved | 7/30/2012 |
| TOPOTECAN HYDROCHLORIDE 1 MG/ML | 09P-0077/CP1 PHARMAFORCE | INJECTION | Pending | 2/19/2009 |
| TRAMADOL HYDROCHLORIDE 100 MG | 08P-0327/CP1 KENDLE REGULATORY AFFAIRS | TABLETS | Approved | 3/18/2010 |
| TRAMADOL HYDROCHLORIDE 50 MG PER 5 ML | 04P-0405/CP1 LACHMAN CONSULTANT SERVICES | ORAL SOLUTION | Denied | 7/28/2005 |
| TRAMADOL HYDROCHLORIDE 75 MG ACETAMINOPHEN 650 MG | 09P-0429 LACHMAN CONSULTANT SERVICES | TABLETS | Withdrawn | 11/30/2011 |
| TRETINOIN 0.0375%, 0.075% | 05P-0417/CP1 TRIAX PHARMACEUTICALS | CREAM | Approved | 5/9/2007 |
| TRIAMTERENE 50 MG HYDROCHLOROTHIAZIDE 25 MG | 12P-0061 LANNETT COMPANY | CAPSULES | Withdrawn | 2/10/2012 |
| TRIAMTERENE 50 MG HYDROCHLOROTHIAZIDE 25 MG | 87P-0335/CP PAR | TABLET | Withdrawn | 3/26/2007 |
| TRIAZOLAM 0.125 MG/5 ML | 92P-0048/CP2 ROXANE | ORAL SOLUTION | Withdrawn | 3/26/2007 |
| TRIMETHOPRIM 25 MG/5 ML | 92P-0500/CP1 ASCENT PHARMS | ORAL SOLUTION | Withdrawn | 3/26/2007 |
| TRIPELENNAMINE HYDROCHLORIDE 25 MG/5 ML DEXTROMETHORPHAN HYDROBROMIDE 15 MG/5 ML | 95P-0345/CP1 BOCK PHARMACEUTICAL COMPANY | SYRUP;ORAL | Withdrawn | 3/23/2000 |
| URSODIOL 100 MG/5 ML | 00P-1568/CP1 LACHMAN CONSULTANT SERVICES | SUSPENSION; ORAL | Denied | 7/9/2002 |
| URSODIOL 100, 200, 400 MG | 06P-0505/CP1 LACHMAN CONSULTANT SERVICES | CAPSULES | Approved | 8/28/2007 |
| URSODIOL 20 MG/ML | 03P-0082/CP1 LACHMAN CONSULTANT SERVICES | ORAL SUSPENSION | Approved | 2/3/2004 |
| URSODIOL 20 MG/ML | 05P-0315/CP1 CANREG | ORAL SUSPENSION | Pending | 8/19/2005 |
| VALRUBICIN 800 MG/20 ML | 12P-1029 LACHMAN CONSULTANT SERVICES | SOLUTION | Pending | 10/23/2012 |
| VANCOMYCIN HYDROCHLORIDE 100 GRAM VIAL | 05P-0242/CP1 SAMSON MEDICAL TECHNOLOGIES | FOR INJECTION | Approved | 4/19/2006 |
| VANCOMYCIN HYDROCHLORIDE 750 MG | 06P-0533/CP1 KING & SPALDING | INJECTION | Approved | 8/22/2007 |
| VANCOMYCIN HYDROCHLORIDE 750 MG | 06P-0534/CP1 KING ANS SPALDING | INJECTION | Approved | 8/22/2007 |
| VENLAFAXINE HYDROCHLORIDE 225 MG, 300 MG | 08P-0247/CP1 KENDLE REGULATORY AFFAIRS | TABLET; EXTENDED-RELEASE; ORAL | Withdrawn | 11/21/2008 |
| VENLAFAXINE HYDROCHLORIDE 37.5MG, 75MG, 150MG | 03P-0159/PSA1 COVINGTON & BURLING | TABLET; EXTENDED-RELEASE; ORAL | Withdrawn | 6/10/2009 |
| VENLAFAXINE HYDROCHLORIDE 37.5MG, 75MG, 150MG | 03P-0159/CP1 LACHMAN CONSULTANT SERVICES | EXTENDED RELEASE TABLETS | Approved | 3/30/2005 |
| VENLAFAXINE HYDROCHLORIDE 37.5MG, 75MG, 150MG | 03P-0159/PRC1 COVINGTON & BURLING | TABLET; EXTENDED-RELEASE; ORAL | Withdrawn | 6/10/2009 |
| VERAPAMIL HYDROCHLORIDE 120 MG OR 240 MG | 87P-0233/CP SEARLE | EXTENDED-RELEASE CAPSULE | Withdrawn | 3/26/2007 |
| VERAPAMIL HYDROCHLORIDE 40MG/5ML OR 80MG/5ML | 87P-0101/CP MY-K | ORAL SOLUTION | Withdrawn | 3/26/2007 |
| VINCRISTINE SULFATE 2 MG | 85P-0084/CP BRISTOL | FOR INJECTION | Withdrawn | 3/26/2007 |
| WARFARIN SODIUM 0.5 mg | 02P-0498/CP1 TARO PHARMACEUTICALS | TABLETS | Approved | 4/14/2003 |
| WARFARIN SODIUM 1 MG/ML | 05P-0307/CP1 MORTON GROVE PHARMACEUTICALS | ORAL SOLUTION | Pending | 8/9/2005 |
| WARFARIN SODIUM 1.5 MG | 03P-0307/CP1 TARO PHARMACEUTICALS | TABLETS | Approved | 10/6/2003 |
| WATER FOR INJECTION 3 ML, 5 ML, 15 ML 30 ML | 06P-0273/CP1 BECKLOFF ASSOCIATES | INJECTION | Approved | 8/22/2007 |
| WATER FOR INJECTION USP 0.5, 1.0, 1.5, 2.0, 2.5, 4.0, 6.0, 7.0, | 11P-0818 JUBILANT HOLLISTERSTIER | INJECTION | Pending | 1/10/2012 |
| ZALEPLON 7.5 MG | 07P-0398/CP1 LACHMAN CONSULTANT SERVICES | CAPSULES | Pending | 10/23/2007 |
| ZIDOVUDINE 100 MG | 08P-0407/CP1 MATRIX LABORATORIES | TABLETS | Pending | 7/31/2008 |
| ZOLPIDEM TARTRATE 5 MG, 10 MG | 09P-0248/CP LACHMAN CONSULTANT SERVICES | TABLET; EFFERVESCENT | Pending | 6/1/2009 |
| ZOLPIDEM TARTRATE 5 MG, 10 MG | 07P-0042/CP1 LACHMAN CONSULTANT SERVICES | ORALLY DISSOLVING STRIPS | Withdrawn | 6/1/2009 |
| ZOLPIDEM TARTRATE 7.5 MG | 10P-0015 LACHMAN CONSULTANT SERVICES | TABLETS | Pending | 1/12/2010 |
-
-
