| 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Withdrawn |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
|
94P-0212/CP1
MIKART
|
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Withdrawn |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Withdrawn |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Withdrawn |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Withdrawn |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-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Withdrawn |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Withdrawn |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Withdrawn |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Withdrawn |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
CODEINE PHOSPHATE 30 MG
|
85P-0543/CP
SOFTAN
|
SOFT GELATIN CAPSULE |
Withdrawn |
3/26/2007 |
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 325 MG
PROPOXYPHENE NAPSYLATE 100 MG
|
99P-2247/CP1
MIKART INC.
|
TABLET; ORAL, CAPSULE;ORAL |
Denied |
3/2/2001 |
ACETAMINOPHEN 325 MG
BUTALBITAL 50 MG
|
93P-0346/CP1
MIKART
|
CAPSULE OR TABLET |
Withdrawn |
3/26/2007 |
ACETAMINOPHEN 325 MG
ASPIRIN 325 MG
|
86P-0361/CP
BOCK PHARMA
|
TABLET |
Withdrawn |
3/26/2007 |
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 |
Pending |
1/25/2007 |
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
OXYCODONE HYDROCHLORIDE 10 mg
|
99P-2798/CP1
KING AND SPALDING
|
TABLET; ORAL |
Approved |
6/13/2000 |
ACETAMINOPHEN 500 MG
BUTALBITAL 50 MG
|
99P-2149/CP1
MIKART INC.
|
TABLET; ORAL, CAPSULE;ORAL |
Denied |
4/14/2000 |
ACETAMINOPHEN 500 MG
OXYCODONE HYDROCHLORIDE 5 MG
|
85P-0543/CP3
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
PROPOXYPHENE HYDROCHLORIDE 32 MG
|
85P-0581/CP
SOFTAN
|
SOFT GELATIN CAPSULE |
Withdrawn |
3/26/2007 |
ACETAMINOPHEN 500 MG
CODEINE PHOSPHATE 30 MG OR 60 MG
|
84P-0228/CP1
MCNEIL
|
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/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 |
Pending |
7/16/2007 |
ACETAMINOPHEN 650 MG
BUTALBITAL 50 MG
|
07P-0194/CP1
LACHMAN CONSULTANT SERVICES
|
CAPSULES |
Pending |
5/22/2007 |
ACETAMINOPHEN 650 MG
BUTALBITAL 50 MG
|
99P-1657/CP1
MIKART INC.
|
TABLET; ORAL, CAPSULE;ORAL |
Approved |
4/14/2000 |
ACETAMINOPHEN 650 MG
CODEINE PHOSPHATE 15 MG
|
86P-0200/CP
MIKART
|
CAPSULE OR TABLET |
Withdrawn |
3/26/2007 |
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
PROPOXYPHENE NAPSYLATE 100 MG
|
00P-1324/CP1
MIKART
|
TABLETS AND/OR CAPSULES |
Denied |
4/30/2001 |
ACETAMINOPHEN; 500 MG
HYDROCODONE BITARTRATE 10 MG
|
01P-0251/CP1
MALLINKRODT
|
SOLUTION; ORAL |
Withdrawn |
8/23/2001 |
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 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 |
Pending |
9/13/2006 |
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 |
Pending |
4/4/2007 |
AMINO ACID 15 % 1 L GLASS BOTTLE
|
07P-0300/CP1
B. BRAUN MEDICAL
|
INJECTION |
Pending |
8/8/2007 |
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 |
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 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 10MG/20MG/40MG/80MG
|
04P-0418/CP1
LACHMAN CONSULTANT SERVICES
|
CAPSULES |
Withdrawn |
7/1/2005 |
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 |
Suspended |
2/3/2004 |
BACLOFEN 10 MG/5 ML
|
05P-0156/CP1
PHASE V PHARMACEUTICALS
|
ORAL SOLUTION |
Withdrawn |
7/18/2005 |
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 |
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 |
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
ACETAMINOPHEN 325 MG
|
95P-0279/CP1
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 325 MG
|
95P-0279/CP2
MIKART
|
CAPSULES AND TABLETS |
Withdrawn |
3/26/2007 |
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 |
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 |
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
|
03P-0304/CP1
TARO PHARMACEUTICALS
|
ORAL SUSPENSION |
Pending |
|
CARBAMAZEPINE 200 MG/5 ML
|
89P-0399/CP
GUIDELINES
|
ORAL SUSPENSION |
Withdrawn |
3/26/2007 |
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 |
CARBOPLATIN 1000 MG/100 ML
MULTIPLE DOSE VIAL
|
05P-0398/CP1
LACHMAN CONSULTANT SERVICES
|
INJECTION |
Pending |
10/5/2005 |
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 |
Suspended |
2/3/2004 |
CARISOPRODOL 200 MG
|
01P-0526/CP1
ATLEY PHARMACEUTICALS, INC.
|
TABLET; ORAL |
Denied |
7/3/2002 |
CARISOPRODOL 200 MG
ACETAMINOPHEN 325 MG
|
03P-0460/CP1
ANABOLIC LABORATORIES, INC.
|
TABLET; ORAL |
Pending |
2/4/2004 |
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 |
CEFIXIME 100 MG/ML
|
07P-0404/CP1
LUPIN PHARMACEUTICALS
|
ORAL SUSPENSION |
Pending |
10/31/2007 |
CEFIXIME 100MG, 150MG, 200MG
|
04P-0263/CP1
LUPIN PHARMACEUTICALS
|
CHEWABLE TABLETS |
Approved |
10/6/2005 |
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 |
Pending |
|
CEFTRIAXONE 100 GRAM
|
05P-0114/CP1
SAMSON MEDICAL TECHNOLOGIES
|
INJECTION |
Approved |
7/14/2005 |
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 |
Pending |
3/24/2006 |
CETIRIZINE HYDROCHLORIDE 5 MG; 10 MG
|
06P-0207/CP1
STRIDES
|
CAPSULES, SOFT GELATIN |
Pending |
6/12/2006 |
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 |
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 |
Pending |
5/24/2004 |
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%
RLD = TEMOVATE
|
90P-0198/CP
KROSS
|
LOTION |
Withdrawn |
3/26/2007 |
CLOBETASOL PROPIONATE 0.05%
|
06P-0387/CP1
PADDOCK LABORATORIES
|
FOAM |
Pending |
9/21/2006 |
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 |
CLOZAPINE 12.5 MG
|
99P-1267/CP1
LACHMAN CONSULTANT SERVICES
|
TABLET;ORAL |
Approved |
2/17/2000 |
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 |
CODEINE PHOSPHATE 10 MG/5 ML
DEXBROMPHENIRAMINE MALEATE 1 MG/5 ML
|
85P-0269/CP
BOCK PHARMA
|
SYRUP |
Withdrawn |
3/26/2007 |
COLISTIMETHATE SODIUM 150 MG/2 ML
|
05P-0050/CP1
PRG CONSULTING
|
SOLUTION |
Approved |
10/17/2005 |
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 |
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
PSEUDOEPHEDRINE SULFATE 120 MG
|
85P-0140/CP2
CENTRAL PHARMS
|
EXTENDED-RELEASE CAPSULE |
Withdrawn |
3/26/2007 |
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 HYDROCHLORIDE 120 MG
|
85P-0140/CP
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 |
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 |
Pending |
2/3/2004 |
DICLOFENAC SODIUM 50 MG, 75 MG
MISOPROSTOL 200 MCG
|
07P-0428/CP1
KING & SPALDING LLP
|
CAPSULES |
Pending |
11/5/2007 |
DIFLUNISAL USP 375 MG
|
07P-0247/CP1
LACHMAN CONSULTANT SERVICES
|
TABLETS |
Pending |
6/26/2007 |
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 = TIAZAC
|
97P-0195/CP1
LABOPHARM INC
|
TABLET; EXTENDED-RELEASE; ORAL |
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 125MG/5ML;250MG/10ML
|
98P-0189/CP1
BEDFORD LABORATORIES
|
INJECTION |
Withdrawn |
|
DIPHENOXYLATE HYDROCHLORIDE 5 MG
ATROPINE SULFATE 0.05 MG
|
05P-0161/CP1
LACHMAN CONSULTANT SERVICES
|
TABLETS |
Pending |
5/4/2005 |
DIPHENOXYLATE HYDROCHLORIDE 5 MG
ATROPINE SULFATE 0.05 MG/5 ML
|
05P-0162/CP1
LACHMAN CONSULTANT SERVICES
|
ORAL SOLUTION |
Pending |
5/4/2005 |
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 |
DONEPEZIL HYDROCHLORIDE 5 MG, 10 MG
|
07P-0226/CP1
LACHMAN CONSULTANT SERVICES
|
ORALLY DISSOLVING FILM STRIPS |
Pending |
6/18/2007 |
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-0109/CP1
THE WEINBERG GROUP INC.
|
CAPSULE; ORAL |
Approved |
8/2/2001 |
DOXYCYCLINE 75 MG
|
01P-0515/CP1
LACHMAN CONSULTANT SERVICES
|
TABLET; ORAL |
Approved |
4/12/2002 |
DOXYCYCLINE (MONOHYDRATE) 125 MG
|
06P-0417/CP1
LACHMAN CONSULTANT SERVICES
|
TABLETS |
Pending |
10/24/2006 |
DOXYCYCLINE HYCLATE 75 MG, 100 MG
|
04P-0390/CP1
LACHMAN CONSULTANT SERVICES
|
TABLETS |
Pending |
9/21/2004 |
DOXYCYCLINE HYCLATE 75 MG, 100 MG
|
04P-0054/CP1
URL MUTUAL
|
CAPSULES |
Withdrawn |
4/12/2004 |
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
|
05P-0407/CP1
LACHMAN CONSULTANT SERVICES
|
TABLETS FOR ORAL SUSPENSION |
Pending |
10/12/2005 |
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
|
07P-0239/CP1
LACHMAN CONSULTANT SERVICES
|
ORALLY DISSOLVING FILM STRIPS |
Pending |
6/21/2007 |
ESMOLOL HYDROCHLORIDE 2500 MG/VIAL
|
04P-0085/CP1
BEDFORD LABORATORIES
|
INJECTION |
Denied |
6/7/2005 |
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
|
04P-0353/CP1
LACHMAN CONSULTANT SERVICES
|
ORALLY DISSOLVING STRIPS |
Approved |
7/5/2005 |
FAMOTIDINE 10 MG
|
97P-0404/CP1
THOMAS BLAKE, R.PH
|
TABLET; ORAL; EFFERVESCENT |
Withdrawn |
3/26/2007 |
FAMOTIDINE 10MG
|
00P-1422/CP1
YAMANOUCHI PHARMA TECHNOLOGIES
|
TABLET; ORALLY DISINTEGRATING |
Approved |
4/17/2001 |
FENOFIBRATE 107 mg
|
02P-0148/CP1
LAVENDER CONSULTING SERVICES
|
TABLETS |
Approved |
9/25/2002 |
FENOPROFEN CALCIUM 400 MG
|
07P-0293/CP1
EMCURE PHARMACEUTICALS
|
CAPSULES |
Pending |
7/26/2007 |
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 |
Pending |
1/19/2007 |
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 F18 0.9-475 MCI/ML
|
07P-0126/CP1
PFI LLC
|
INJECTION |
Pending |
4/9/2007 |
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 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 |
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 500 MG/10 ML
|
01P-0440/CP1
BEN VENUE LAOBRATORIES, INC.
|
INJECTION |
Suspended |
2/3/2004 |
GEMCITABINE 2 GM/VIAL
|
06P-0145/CP1
LACHMAN CONSULTANT SERVICES
|
INJECTION |
Approved |
8/22/2007 |
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
|
04P-0208/CP1
THE WEINBERG GROUP
|
TABLETS FOR ORAL SUSPENSION |
Approved |
11/23/2004 |
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 |
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 1.5 MG
|
06P-0300/CP1
LACHMAN CONSULTANT SERVICES
|
TABLETS |
Approved |
3/20/2007 |
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
IBUPROFEN 200 MG
|
01P-0442/CP1
LACHMAN CONSULTANT SERVICES
|
TABLET; ORAL |
Approved |
12/20/2001 |
HYDROCODONE BITARTRATE 10 MG
ACETAMINOPHEN 300 MG
|
01P-0441/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
IBUPROFEN 200 MG
|
05P-0180/CP1
LACHMAN CONSULTANT SERVICES
|
TABLETS |
Approved |
7/14/2005 |
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 PER 5 ML
HOMATROPINE METHYLBROMIDE 0.75 MG PER 5 ML
|
07P-0119/CP1
LACHMAN CONSULTANT SERVICES
|
SYRUP |
Pending |
4/5/2007 |
