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Drugs

OGD Suitability Tracking Report (Sorted by Petition Number)

Drug/StrengthPetition No/FirmDosage FormStatusStatus Date
CEFTAZIDIME 3 GRAM/VIAL

14P-0282
CUSTO PHARM INC
INJECTIONPending3/10/2014 
ACETAZOLAMIDE 500 MG

13P-1296
LANNETT COMPANY
TABLET; EXTENDED-RELEASE; ORALPending10/24/2013 
LIDOCAINE HYDROCHLORIDE 20 MG/ML
EPINEPHRINE BITARTRATE 0.01 MG/ML
10P-0072
ARENT FOX
INJECTIONWithdrawn3/22/2010 
ACETAMINOPHEN 500 MG
CODEINE PHOSPHATE 30 MG OR 60 MG
84P-0228/CP1
MCNEIL
CAPSULEWithdrawn3/26/2007 
METHYLTESTOSTERONE 25 MG

85P-0067/CP
STAR PHARMS
CAPSULEWithdrawn3/26/2007 
HYDRALAZINE HYDROCHLORIDE 25 MG/5ML

85P-0074/CP
ROXANE
ORAL SOLUTIONWithdrawn3/26/2007 
FLURAZEPAM HYDROCHLORIDE 30 MG/ML

85P-0081/CP
ROXANE
ORAL SOLTUIONWithdrawn3/26/2007 
FLURAZEPAM HYDROCHLORIDE 15 MG/5ML

85P-0091/CP
ROXANE
ORAL SOLUTIONWithdrawn3/26/2007 
BROMPHENIRAMINE MALEATE 12 MG
PSEUDOEPHEDRINE HYDROCHLORIDE 120 MG
83N-0095/CP
UAD LABS
EXTENDED-RELEASE CAPSULEWithdrawn3/26/2007 
VINCRISTINE SULFATE 2 MG

85P-0084/CP
BRISTOL
FOR INJECTIONWithdrawn3/26/2007 
PROPRANOLOL HYDROCHLORIDE 160 MG

85P-0129/CP
VEREX
EXTENDED-RELEASE TABLETWithdrawn3/26/2007 
LORAZEPAM 0.5 MG, 1 MG OR 2 MG

85P-0515/CP
WYETH
TABLET (FAST-DISSOLVING)Withdrawn3/26/2007 
DEXBROMPHENIRAMINE MALEATE 6 MG
PSEUDOEPHEDRINE HYDROCHLORIDE 120 MG
85P-0140/CP
CENTRAL PHARMS
EXTENDED-RELEASE CAPSULEWithdrawn3/26/2007 
KETOCONAZOLE 20 MG/ML

85P-0147/CP
JANSSEN
ORAL SUSPENSIONWithdrawn3/26/2007 
PROPRANOLOL HYDROCHLORIDE 80 MG, 120 MG, 160MG

85P-0197/CP
FOREST PHARMS
EXTENDED-RELEASE TABLETWithdrawn3/26/2007 
DISULFIRAM 500 MG/30 ML

85P-0215/CP
PADDOCK
ORAL SUSPENSIONWithdrawn3/26/2007 
DEXBROMPHENIRAMINE MALEATE 6 MG
PHENYLPROPANOLAMINE HYDROCHLORIDE 75 MG
85P-0238/CP2
BOCK PHARMA
EXTENDED-RELEASE CAPSULEWithdrawn3/26/2007 
CODEINE PHOSPHATE 10 MG/5 ML
DEXBROMPHENIRAMINE MALEATE 1 MG/5 ML
85P-0269/CP
BOCK PHARMA
SYRUPWithdrawn3/26/2007 
BENZTROPINE MESYLATE 0.5 MG/5 ML

85P-0423/CP
RIM CONSULTING
SYRUPWithdrawn3/26/2007 
AZATADINE MALEATE 1 MG
PHENYLPROPANOLAMINE HYDROCHLORIDE 75 MG
85P-0492/CP
SKF
EXTENDED-RELEASE CAPSULEWithdrawn3/26/2007 
DIAZEPAM 2 MG/5 ML

85P-0499/CP
CAROLINA MEDCL
SYRUPWithdrawn3/26/2007 
SPIRONOLACTONE 25 MG/5 ML

85P-0510/CP
CAROLINA MEDCL
SYRUPWithdrawn3/26/2007 
OXAZEPAM 15 MG OR 30 MG

85P-0516/CP
WYETH
TABLETWithdrawn3/26/2007 
ACETAMINOPHEN 300 MG
CODEINE PHOSPHATE 30 MG
85P-0543/CP
SOFTAN
SOFT GELATIN CAPSULEWithdrawn3/26/2007 
ACETAMINOPHEN 500 MG
CODEINE PHOSPHATE 7.5 OR 15 MG
85P-0543/CP2
SOFTAN
SOFT GELATIN CAPSULEWithdrawn3/26/2007 
DEXBROMPHENIRAMINE MALEATE 6 MG
PSEUDOEPHEDRINE SULFATE 120 MG
85P-0140/CP2
CENTRAL PHARMS
EXTENDED-RELEASE CAPSULEWithdrawn3/26/2007 
IBUPROFEN 300, 400 OR 600 MG

85P-0563/CP
SOFTAN
SOFT GELATIN CAPSULEWithdrawn3/26/2007 
ACETAMINOPHEN 500 MG
OXYCODONE HYDROCHLORIDE 5 MG
85P-0543/CP3
SOFTAN
SOFT GELATIN CAPSULEWithdrawn3/26/2007 
ACETAMINOPHEN 500 MG
PROPOXYPHENE HYDROCHLORIDE 32 MG
85P-0581/CP
SOFTAN
SOFT GELATIN CAPSULEWithdrawn3/26/2007 
PROPRANOLOL HYDROCHLORIDE 10,20,40,60,80,90 MG

86P-0045/CP
NUTRIPHARM LABS
CAPSULEWithdrawn3/26/2007 
SPIRONOLACTONE 25 MG/5 ML

86P-0055/CP
CAROLINA MEDCL
ORAL SUSPENSIONWithdrawn3/26/2007 
CHOLESTYRAMINE 4 GM

86P-0123/CP
PARKE DAVIS
CHEWABLE TABLETWithdrawn3/26/2007 
DISOPYRAMIDE PHOSPHATE 200 MG OR 300 MG

84N-0116/CP
BIOCRAFT
EXTENDED-RELEASE TABLETWithdrawn3/26/2007 
ACETAMINOPHEN 650 MG
CODEINE PHOSPHATE 15 MG
86P-0200/CP
MIKART
CAPSULE OR TABLETWithdrawn3/26/2007 
FLOXURIDINE 500 MG/5 ML

86P-0242/CP
QUAD
INJECTIONWithdrawn3/26/2007 
LORAZEPAM 1 MG/5 ML

86P-0292/CP
ROXANE
ORAL SOLUTIONWithdrawn3/26/2007 
ASPIRIN 356.4MG
CAFFEINE 30 MG
86P-0359/CP
CENTRAL PHARMS
TABLETWithdrawn3/26/2007 
ACETAMINOPHEN 325 MG
ASPIRIN 325 MG
86P-0361/CP
BOCK PHARMA
TABLETWithdrawn3/26/2007 
HYDROCHLOROTHIAZIDE 50 MG
TRIAMTERENE 75 MG
86P-0427/CP
PAR
CAPSULEWithdrawn3/26/2007 
CHOLESTYRAMINE 500 MG

86P-0474/CP
BRISTOL MYERS
CAPSULEWithdrawn3/26/2007 
FLUOCINONIDE 0.05%

87P-0004/CP
HAMER
LOTIONWithdrawn3/26/2007 
LORAZEPAM 0.5 MG, 1 MG, 2 MG

87P-0037/CP
APPLIED LABS
SOFT GELATIN CAPSULEWithdrawn3/26/2007 
VERAPAMIL HYDROCHLORIDE 40MG/5ML OR 80MG/5ML

87P-0101/CP
MY-K
ORAL SOLUTIONWithdrawn3/26/2007 
VERAPAMIL HYDROCHLORIDE 120 MG OR 240 MG

87P-0233/CP
SEARLE
EXTENDED-RELEASE CAPSULEWithdrawn3/26/2007 
IBUPROFEN 800 MG

87P-0242/CP
SIDMAK
SOFT GELATIN CAPSULEWithdrawn3/26/2007 
DEXBROMPHENIRAMINE MALEATE 6 MG
PHENYLPROPANOLAMINE HYDROCHLORIDE 75 MG
87P-0265/CP
BOCK PHARMA
CONTROLLED-RELEASE TABLETWithdrawn3/26/2007 
LOPERAMIDE HYDROCHLORIDE 2 MG

87P-0268/CP
KROSS
TABLETWithdrawn3/26/2007 
CHOLESTYRAMINE RESIN 4 G

87P-0301/CP
CIBA
GELApproved3/26/2007 
CLEMASTINE FUMARATE 1.34 MG
PSEUDOEPHEDRINE HYDROCHLORIDE 120 MG
87P-0314/CP
SANDOZ
CONTROLLED-RELEASE TABLETWithdrawn3/26/2007 
CHLORZOXAZONE 500 MG

82N-0032/CP6
MIKART
CAPSULEWithdrawn3/26/2007 
ACETAMINOPHEN 160 MG/5ML
CODEINE PHOSPHATE 6 MG/5 ML
87P-0323/CP
KLEINFELD, KAPLAN & BECKER
SYRUPWithdrawn3/26/2007 
TRIAMTERENE 50 MG
HYDROCHLOROTHIAZIDE 25 MG
87P-0335/CP
PAR
TABLETWithdrawn3/26/2007 
NIFEDIPINE 10 MG OR 20 MG

87P-0340/CP
PAR
TABLETWithdrawn3/26/2007 
PHENYTOIN SODIUM 100 MG; 250 MG/VIAL

87P-0367/CP
LYPHOMED
FOR INJECTIONWithdrawn3/26/2007 
PROPRANOLOL HYDROCHLORIDE 40 MG 0R 80 MG/5 ML
HYDROCHLOROTHIAZIDE 25 MG/5 ML
87P-0399/CP
BURDITT, BOWLES, ET. AL.
ORAL SOLUTIONWithdrawn3/26/2007 
CYCLOPHOSPHAMIDE 20 MG/ML, 500 ML,PBP

88P-0011/CP
BAXTER
INJECTIONWithdrawn3/26/2007 
CHLORHEXIDINE GLUCONATE 0.5%

88P-0036/CP
ARENT, FOX, ET. AL
SPRAYWithdrawn3/26/2007 
HOMATROPINE METHYLBROMIDE 1.5 MG
HYDROCODONE BITARTRATE 5 MG
88P-0061/CP
KLEINFELD, KAPLAN & BECKER
SOFT GELATIN CAPSULEWithdrawn3/26/2007 
LEUCOVORIN CALCIUM 1 MG/ML

88P-0149/CP
ROXANE
ORAL SOLUTIONWithdrawn3/26/2007 
QUINIDINE SULFATE 300 MG

88P-0277/CP
ROBINS AH
EXTENDED-RELEASE CAPSULEWithdrawn3/26/2007 
CLEMASTINE FUMARATE 1.34 MG
PHENYLPROPANOLAMINE HYDROCHLORIDE 75 MG
88P-0350/CP
SCI CONSULTING
EXTENDED-RELEASE CAPSULEWithdrawn3/26/2007 
CYCLOPHOSPHAMIDE 20 MG/ML, 250 ML PBP

88P-0379/CP
BAXTER
INJECTIONWithdrawn3/26/2007 
PREDNISONE 1,2.5,5,10,20,25,50

88P-0391/CP
ASCHER
CAPSULEWithdrawn3/26/2007 
HYDROCORTISONE VALERATE 0.2%

89P-0028/CP
MCKENNA, CONNER, ET AL
LOTIONWithdrawn3/26/2007 
HYDROCORTISONE VALERATE 0.2%

89P-0029/CP
MCKENNA, CONNER, ET AL
TOPICAL SOLUTIONWithdrawn3/26/2007 
MORPHINE SULFATE 30 MG

89P-0071/CP
OXFORD RES INTL
EXTENDED-RELEASE CAPSULEWithdrawn3/26/2007 
CARBAMAZEPINE 200 MG/5 ML

89P-0399/CP
GUIDELINES
ORAL SUSPENSIONWithdrawn3/26/2007 
PENTAMIDINE ISETHIONATE 100 MG/ML

89P-0435/CP
ASTRA
INJECTIONWithdrawn3/26/2007 
HYDROCORTISONE ACETATE 2.5% OR 1%

90P-0049/CP
FERNDALE
CREAM OR LOTIONWithdrawn3/26/2007 
CHLORZOXAZONE 250 MG

90P-0084/CP1
MIKART
CAPSULEWithdrawn3/26/2007 
HYDROCORTISONE ACETATE 1%

90P-0154/CP
FERNDALE
OINTMENTWithdrawn3/26/2007 
CLOBETASOL PROPIONATE 0.05%
RLD = TEMOVATE
90P-0198/CP
KROSS
LOTIONWithdrawn3/26/2007 
NIFEDIPINE 30 MG, 60 MG, 90 MG

90P-0436/CP1
KV
EXTENDED-RELEASE CAPSULEWithdrawn3/26/2007 
ALBUTEROL SULFATE 4 MG

91P-0348/CP1
HAMER
CAPSULE; ETENDED-RELEASEWithdrawn3/26/2007 
TRIAZOLAM 0.125 MG/5 ML

92P-0048/CP2
ROXANE
ORAL SOLUTIONWithdrawn3/26/2007 
HYDROCORTISONE ACETATE 2.5%

92P-0101/CP
HOGAN & HARTSON
AEROSOLWithdrawn3/26/2007 
ACETAMINOPHEN 150 MG
ASPIRIN 180 MG
92P-0282/CP1
MIKART
CAPSULE OR TABLETWithdrawn3/26/2007 
ACETAMINOPHEN 150 MG
ASPIRIN 180 MG
92P-0282/CP3
MIKART
CAPSULE OR TABLETWithdrawn3/26/2007 
ACETAMINOPHEN 150 MG
ASPIRIN 180 MG
92P-0282/CP2
MIKART
CAPSULE OR TABLETWithdrawn3/26/2007 
ACETAMINOPHEN 150 MG
ASPIRIN 180 MG
92P-0282/CP4
MIKART
CAPSULE OR TABLETWithdrawn3/26/2007 
PROPRANOLOL HYDROCHLORIDE 40 MG

92P-0232/CP1
FLEMINGTON
EFFERVESCENT TABLETWithdrawn3/26/2007 
ALBUTEROL SULFATE 2 MG, AND
4 MG
92P-0335/CP1
WE PHARMS
CHEWABLE TABLETWithdrawn3/26/2007 
PREDNISONE 5 MG OR 10 MG

92P-0336/CP1
WE PHARMS
CHEWABLE TABLETWithdrawn3/26/2007 
CYTARABINE 20 MG/ML, 12.5 ML

92P-0381/CP1
BRISTOL-MYERS SQUIBB
INJECTIONWithdrawn3/26/2007 
TRIMETHOPRIM 25 MG/5 ML

92P-0500/CP1
ASCENT PHARMS
ORAL SOLUTIONWithdrawn3/26/2007 
ACETAMINOPHEN 500 MG
CODEINE PHOSPHATE 45 MG
93P-0314/CP1
MIKART
CAPSULE OR TABLETWithdrawn3/26/2007 
CIMETIDINE 200,300,400 OR 800MG

93P-0048/CP1
FLEMINGTON
EFFERVESCENT TABLETWithdrawn3/26/2007 
PROPRANOLOL HYDROCHLORIDE 10, 20, 60, 80, 90MG

93P-0049/CP1
FLEMINGTON
EFFERVESCENT TABLETWithdrawn3/26/2007 
ACETAMINOPHEN 325 MG
BUTALBITAL 50 MG
93P-0346/CP1
MIKART
CAPSULE OR TABLETWithdrawn3/26/2007 
PREDNISONE 1,2.5,20,50 MG

93P-0333/CP1
DURA PHARMS
CHEWABLE TABLETWithdrawn3/26/2007 
LOPERAMIDE HYDROCHLORIDE 1 MG

93P-0332/CP1
ELLIS PHARM
EFFERVESCENT TABLETWithdrawn3/26/2007 
TERFENADINE 60 MG
PSEUDOEPHEDRINE 120 MG
93P-0367/CP1
EURAND AMERICA
EXTENDED-RELEASE CAPSULEWithdrawn3/26/2007 
MORPHINE SULFATE 15MG,60MG,90MG,100MG

93P-0446/CP1
ETHYPHARM
EXTENDED-RELEASE CAPSULEWithdrawn3/26/2007 
METHYLTESTOSTERONE 25 MG

93P-0459/CP1
ICN
CAPSULEWithdrawn3/26/2007 
ACETAMINOPHEN 120 MG
CODEINE PHOSPHATE 12 MG
94P-0182/CP1
WE PHARMS
CHEWABLE TABLETWithdrawn3/26/2007 
SULFAMETHOXAZOLE 200 MG
TRIMETHOPRIM 40 MG
94P-0186/CP1
DURA
CHEWABLE TABLETWithdrawn3/26/2007 
ACETAMINOPHEN 150 MG
ASPIRIN 180 MG
94P-0210/CP1
MIKART
TABLETWithdrawn3/26/2007 
ACETAMINOPHEN 150 MG
ASPIRIN 180 MG
94P-0211/CP1
MIKART
TABLETWithdrawn3/26/2007 
ACETAMINOPHEN 150 MG
ASPIRIN 180 MG
94P-0212/CP1
MIKART
TABLETWithdrawn3/26/2007 
FLUOROURACIL 5%

94P-0263/CP1
BRADLEY PHARMS
TOPICAL GELWithdrawn3/26/2007 
LEUCOVORIN CALCIUM 10 MG/ML 350 MG VIAL

94P-0433/CP1
LEDERLE LABORATORIES
INJECTABLE; INJECTIONWithdrawn3/26/2007 
LEUCOVORIN CALCIUM 10 MG/ML 5 ML VIAL

94P-0433/CP2
LEDERLE LABORATORIES
INJECTABLE; INJECTIONWithdrawn3/26/2007 
METHYLPREDNISOLONE 16 MG
24 MG
94P-0432/CP1
DURA PHARMACEUTICALS
TABLET; CHEWABLEWithdrawn3/26/2007 
CAPTOPRIL 25 MG/ML

95P-0008/CP1
ROXANE LABS, INC.
ORAL SOLUTIONWithdrawn3/26/2007 
CARBIDOPA/LEVODOPA 25/100 MG
25/250 MG
95P-0100/CP1
ATHENA NEUROSCIENCES, INC.
POWDER FOR ORAL SOLUTIONWithdrawn3/26/2007 
HYDROCORTISONE BUTYRATE 0.1%

95P-0223/CP1
MCKENNA & CUNEO, L.L.P.
LOTION; TOPICALWithdrawn3/26/2007 
ACYCLOVIR SODIUM 5 MG/ML

95P-0268/CP1
WILMER, CUTLER, PICKERING
READY TO USE INFUSIONWithdrawn3/26/2007 
CHOLESTYRAMINE 2 G

95P-0277/CP1
MAYRAND PHARMACEUTICALS, INC
TABLET; ORAL (CHEWABLE)Withdrawn3/26/2007 
BUTALBITAL 50 MG
ACETAMINOPHEN 325 MG
95P-0279/CP1
MIKART
CAPSULES AND TABLETSWithdrawn3/26/2007 
BUTALBITAL 50 MG
ACETAMINOPHEN 325 MG
95P-0279/CP2
MIKART
CAPSULES AND TABLETSWithdrawn3/26/2007 
BUTALBITAL 50 MG
ACETAMINOPHEN 500 MG
95P-0279/CP3
MIKART
CAPSULES AND TABLETSWithdrawn3/26/2007 
BUTALBITAL 50 MG
ACETAMINOPHEN 500 MG
95P-0279/CP4
MIKART
CAPSULES AND TABLETSWithdrawn3/26/2007 
NIFEDIPINE 30 MG, 60 MG, 90 MG

95P-0326/CP1
KV PHARMACEUTICAL
CAPSULE, EXTENDED RELEASE; ORALWithdrawn3/26/2007 
METRONIDAZOLE 0.75%

95P-0328/CP1
RNB PHARMACEUTICAL COMPANY
LOTION; TOPICALWithdrawn3/26/2007 
TRIPELENNAMINE HYDROCHLORIDE 25 MG/5 ML
DEXTROMETHORPHAN HYDROBROMIDE 15 MG/5 ML
95P-0345/CP1
BOCK PHARMACEUTICAL COMPANY
SYRUP;ORALWithdrawn3/23/2000 
AZATADINE MALEATE 1 MG
PHENYLEPHRINE HYDROCHLORIDE 30 MG
95P-0351/CP1
BOCK PHARMACEUTICAL COMPANY
TABLET; ORALWithdrawn3/23/2000 
POTASSIUM CHLORIDE 10 mEq

96P-0054/CP1
KV PHARMACEUTICAL COMPANY
FOR ORAL SUSPENSION EXTENDED-RELEASEWithdrawn3/26/2007 
POTASSIUM CHLORIDE 20 mEq

96P-0018/CP1
KV PHARMACEUTICAL
EXTENDED-RELEASE CAPSULESWithdrawn3/26/2007 
ASPIRIN 650 MG
BUTALBITAL 50 MG
96P-0021/CP1
SAVAGE LABS
CAPSULESWithdrawn3/26/2007 
PENTOXYFYLLINE 400 MG

96P-0079/CP1
KV PHARMACEUTICAL COMPANY
EXTENDED-RELEASE PACKET (MICROPARTICLE)Withdrawn3/26/2007 
LACTULOSE 10 G, 20 G

96P-0155/CP1
BENNETT AND COMPANY
POWDER FOR ORAL SOLUTION (EFFERVESCENT)Withdrawn4/24/2000 
ACYCLOVIR 5%

96P-0307/CP1
PITNEY, HARDIN, KIPP & SZUCH
CREAM; TOPICALWithdrawn3/26/2007 
HYDROCORTISONE ACETATE 90 MG

96P-0376/CP1
PITNEY, HARDIN, KIPP & SZUCH
SUPPOSITORY; RECTALWithdrawn3/26/2007 
DILTIAZEM HYDROCHLORIDE 120 MG 180 MG 240 MG
RLD=CARDIAZEM CD
96P-0510/CP1
LABOPHARM INC.
TABLETS;EXTENDED-RELEASEWithdrawn3/26/2007 
PREDNISOLONE SODIUM PHOSPHATE 15 MG/5 ML

96P-0499/CP1
WE PHARMACEUTICALS, INC.
LIQUID; ORALWithdrawn4/5/2000 
PREDNISOLONE SODIUM PHOSPHATE 10 MG (BASE)

96P-0498/CP1
WE PHARMACEUTICALS, INC.
TABLET; CHEWABLEWithdrawn4/5/2000 
MEFENAMIC ACID 250 MG

97P-0155/CP1
PITNEY, HARDIN, KIPP AND SZUCH
TABLET; ORALWithdrawn3/26/2007 
DILTIAZEM HYDROCHLORIDE 120 MG 180 MG 240 MG
RLD=DILACOR XR
97P-0192/CP1
LABOPHARM, INC.
TABLET; EXTENDED-RELEASE; ORALWithdrawn3/26/2007 
DILTIAZEM HYDROCHLORIDE 120 MG 180 MG 240 MG
RLD = TIAZAC
97P-0195/CP1
LABOPHARM INC
TABLET; EXTENDED-RELEASE; ORALWithdrawn3/26/2007 
MORPHINE SULFATE 200 MG

97P-0225/CP1
ETHYPHARM
CAPSULE, EXTENDED RELEASE; ORALApproved4/14/2000 
ALBUTEROL SULFATE 2 MG & 4 MG

97P-0387/CP1
RICHARD A. HAMER ASS., INC.
TABLET; SUBLINGUALWithdrawn3/26/2007 
FAMOTIDINE 10 MG

97P-0404/CP1
THOMAS BLAKE, R.PH
TABLET; ORAL; EFFERVESCENTWithdrawn3/26/2007 
CLOBETASOL PROPIONATE 0.05%
RLD = TEMOVATE E
98P-0068/CP1
RICHARD HAMER ASSOCIATES, INC.
LOTION; TOPICALWithdrawn3/26/2007 
IFOSFAMIDE 50 MG/ML - 20ML&60ML

98P-0146/CP1
MITCHALL G. CLARK
INJECTABLE; INJECTIONWithdrawn3/26/2007 
DILTIAZEM HYDROCHLORIDE 125MG/5ML;250MG/10ML

98P-0189/CP1
BEDFORD LABORATORIES
INJECTIONWithdrawn 
CAPTOPRIL 25 MG/5 ML

98P-0199/CP1
MIRAN CONSULTING, INC.
SOLUTION; ORALWithdrawn3/26/2007 
OMEPRAZOLE 10 MG, 20 MG

98P-0225/CP1
ANDRX PHARMACEUTICALS INC.
TABLET; DELAYED RELEASE; ORALDenied9/16/1999 
HYDROMORPHONE HYDROCHLORIDE 0.2 MG/ML - 30 ML

98P-0821/CP1
ABBOTT LABORATORIES
INJECTABLE; INJECTIONDenied9/29/1999 
ECONAZOLE NITRATE 1%

98P-0745/CP1
MIRAN CONSULTING, INC.
OINTMENT; TOPICALWithdrawn3/26/2007 
CYCLOSPORINE 25 MG; 50 MG; 100 MG

98P-0858/CP1
APOTEX CORP
TABLET; ORALApproved9/16/1999 
METHYLPREDNISOLONE 4 MG & 16 MG

98P-0911/CP1
RICHARD HAMER ASSOCIATES, INC.
TABLET; SUBLINGUALDenied6/14/1999 
ACETAMINOPHEN 325 MG ; 325 MG
OXYCODONE HYDROCHLORIDE 4.5 MG ; 2.25 MG
98P-1219/CP1
KING AND SPALDING
TABLET; ORALDenied2/26/2001 
AMIODARONE 400 MG

99P-0343/CP1
OLSON FRANK AND WEEDA
TABLET; ORALApproved7/21/1999 
KETOROLAC TROMETHAMINE 30 MG/ML - 5 ML

99P-0510/CP1
APOTEX CORP.
INJECTABLE; INJECTIONApproved9/16/1999 
LEVOCARNITINE 200 MG/ML - 12.5 ML

99P-0553/CP1
GENSIA SICOR PHARMACEUTICALS
INJECTABLE; INJECTIONApproved9/16/1999 
IBUPROFEN 200 MG

99P-0683/CP1
FPC CONSULTING INC.
TABLET; ORALWithdrawn9/16/1999 
OMEPRAZOLE 40 MG

99P-1087/CP1
ANDRX PHARMACEUTICALS, INC.
TABLET; DELAYED-RELEASE, ORALApproved4/18/2000 
ETHINYL ESTRADIOL 0.035 MG
NORETHINDRONE 0.4 MG
99P-1150/CP1
KIRKLAND & ELLIS
TABLET; CHEWABLEApproved4/14/2000 
CLOZAPINE 200 MG

99P-1268/CP1
LACHMAN CONSULTANT SERVICES
TABLET; ORALApproved2/17/2000 
CLOZAPINE 12.5 MG

99P-1267/CP1
LACHMAN CONSULTANT SERVICES
TABLET;ORALApproved2/17/2000 
METHYLPHENIDATE HYDROCHLORIDE 2.5 MG

99P-1418/CP1
LACHMAN CONSULTANT SERVICES
TABLET; ORALDenied2/29/2000 
METHYLPHENIDATE HYDROCHLORIDE 5 MG & 10 MG

99P-1417/CP1
LACHMAN CONSULTANT SERVICES
TABLET; CHEWABLEDenied2/29/2000 
METHYLPHENIDATE HYDROCHLORIDE 5 MG/5 ML
10 MG/5 ML
99P-1416/CP1
LACHMAN CONSULTANT SERVICES
SOLUTION; ORALDenied2/29/2000 
PAMIDRONATE DISODIUM 3 MG/ML, 10 ML
9 MG/ML, 10 ML
99P-1653/CP1
MITCHELL G. CLARK
INJECTIONWithdrawn10/14/1999 
ACETAMINOPHEN 650 MG
BUTALBITAL 50 MG
99P-1657/CP1
MIKART INC.
TABLET; ORAL, CAPSULE;ORALApproved4/14/2000 
METHOTREXATE DISODIUM 2.5 MG/ML

99P-2078/CP1
MCKENNA & CUNEO, L.L.P.
FOR ORAL SOLUTIONWithdrawn10/18/1999 
ACETAMINOPHEN 500 MG
BUTALBITAL 50 MG
99P-2149/CP1
MIKART INC.
TABLET; ORAL, CAPSULE;ORALDenied4/14/2000 
ACETAMINOPHEN 750 MG
BUTALBITAL 50 MG
99P-2150/CP1
MIKART INC.
TABLET; ORAL, CAPSULE;ORALApproved4/14/2000 
ACETAMINOPHEN 325 MG
PROPOXYPHENE NAPSYLATE 100 MG
99P-2247/CP1
MIKART INC.
TABLET; ORAL, CAPSULE;ORALDenied3/2/2001 
PAMIDRONATE DISODIUM 3mg/mL - 10 mL
6mg/mL - 10 mL
99P-2252/CP1
FAULDING PHARMACEUTICAL CO.
INJECTIONApproved4/18/2000 
ACETAMINOPHEN 500 MG/15 ML
OXYCODONE HYDROCHLORIDE 7.5 MG/15 ML
99P-2776/CP1
KING AND SPALDING
LIQUID; ORALDenied6/13/2000 
ACETAMINOPHEN 500 mg
OXYCODONE HYDROCHLORIDE 10 mg
99P-2798/CP1
KING AND SPALDING
TABLET; ORALApproved6/13/2000 
ACETAMINOPHEN 400 MG;400 MG:400MG
HYDROCODONE BITARTRATE 5MG;7.5 MG:10 MG
99P-4107/CP1
PHARMACEUTICAL ASSOCIATES, INC
LIQUID; ORALDenied3/2/2001 
METHOTREXATE SODIUM 2.5 MG/ML

99P-2078/CP2
MCKENNA & CUNEO, L.L.P.
FOR ORAL SOLUTIONWithdrawn3/29/2000 
ACETAMINOPHEN 50 MG
PROPOXYPHENE NAPSYLATE 500 MG
99P-4649/CP1
MIKART INC.
TABLET/CAPSULES; ORALDenied3/1/2001 
NALTREXONE HYDROCHLORIDE 25MG, 100MG & 150MG

99P-4775/CP1
LACHMAN CONSULTANT SERVICES
TABLET; ORALApproved4/13/2000 
CEFAZOLIN SODIUM, STERILE 100 G & 300 G

99P-4870/CP1
QUINN CONSULTING SERVICES
FOR INJECTIONApproved4/12/2002 
CEFUROXIME SODIUM, STERILE 75 G & 225 G

99P-4871/CP1
QUINN CONSULTING SERVICES
FOR INJECTIONApproved4/12/2002 
DOXYCYCLINE 50 MG AND 100 MG

99P-4958/CP1
LACHMAN CONSULTANT SERVICES
TABLET; ORALApproved2/4/2000 
OXYCODONE HYDROCHLORIDE 9.25 MG, AND 7.0 MG
OXYCODONE TEREPHTHALATE 0.85 MG, AND 0.57 MG
99P-5105/CP1
KING & SPALDING
TABLET; ORALDenied5/7/2001 
ACYCLOVIR 200 MG

99P-5452/CP1
THE WEINBERG GROUP INC
TABLETS FOR ORAL SUSPENSIONApproved6/13/2000 
ACYCLOVIR 400MG & 800 MG

99P-5453/CP1
THE WEINBERG GROUP INC.
TABLET; FOR ORAL SUSPENSIONApproved6/13/2000 
CEFACLOR 125 MG, 375 MG
375 MG, 500 MG
99P-5448/CP1
THE WEINBERG GROUP INC.
TABLETS FOR ORAL SUSPENSIONApproved6/13/2000 
CEPHALEXIN 125MG,250MG,500MG

99P-5451/CP1
THE WEINBERG GROUP INC
TABLETS FOR ORAL SUSPENSIONApproved6/13/2000 
CEFADROXIL HEMIHYDRATE 125MG,250MG,500MG

99P-5449/CP1
THE WEINBERG GROUP INC.
TABLETS FOR ORAL SUSPENSIONApproved6/13/2000 
CEFACLOR 125 MG, 187 MG
250 MG, 375 MG
99P-5447/CP1
THE WEINBERG GROUP INC.
TABLET; CHEWABLE;ORALApproved6/13/2000 
AMOXICILLIN 125MG,250MG,200MG
400MG,500MG,875MG
99P-5450/CP1
THE WEINBERG GROUP INC.
TABLETS FOR ORAL SUSPENSIONApproved6/13/2000 
PAMIDRONATE DISODIUM 3MG/ML - 10 ML VIALS
9MG/ML - 10 ML VIALS
00P-0091/CP1
MITCHALL G. CLARK
INJECTIONApproved4/18/2000 
THIOTEPA, STERILE 30 MG/VIAL

00P-0092/CP1
GENSIA SICOR
FOR INJECTIONApproved6/14/2000 
ALBUTEROL SULFATE 0.0417%

00P-0913/CP1
MCDERMOTT, WILL AND EMERY
SOLUTION; INHALATIONApproved6/13/2000 
CALCITONIN-SALMON 100 IU/ML-1ML VIALS

00P-1213/CP1
FERRING PHARMACEUTICALS
INJECTIONApproved6/13/2000 
ACETAMINOPHEN; 325 MG & 500MG/15 ML
HYDROCODONE BITARTRATE 10 MG/15 ML
00P-1243/CP1
PHARMACEUTICAL ASSOCIATES, INC
SOLUTION; ORALDenied5/7/2001 
NIZATIDINE 75 MG

00P-1245/CP1
LACHMAN CONSULTANT SERVICES
CAPSULE; ORALApproved4/17/2001 
ACETAMINOPHEN; 325mg and 325 mg
OXYCODONE HYDROCHLORIDE 7.5 mg and 10 mg
00P-1270/CP1
KING AND SPALDING
TABLET; ORALApproved9/9/2000 
ACETAMINOPHEN; 400mg per tab
OXYCODONE HYDROCHLORIDE 2.5mg;5mg;7.5mg;10mg
00P-1271/CP1
KING AND SPALDING
TABLET; ORALApproved9/9/2000 
PROPOFOL 100 MG/10 ML (1%)

00P-1289/CP1
GENSIA SICOR
INJECTIONApproved9/9/2000 
ACETAMINOPHEN; 325MG/10ML
HYDROCODONE BITARTRATE 10MG/10ML
00P-1291/CP1
PHARMACEUTICAL ASSOCIATES, INC
SOLUTION; ORALDenied5/7/2001 
METHIMAZOLE 15 MG AND 20 MG

00P-1308/CP1
LACHMAN CONSULTANT SERVICES
TABLET; ORALApproved9/9/2000 
ACETAMINOPHEN; 500 MG
PROPOXYPHENE NAPSYLATE 100 MG
00P-1324/CP1
MIKART
TABLETS AND/OR CAPSULESDenied4/30/2001 
AMIODARONE HYDROCHLORIDE 900 MG/18 ML

00P-1352/CP1
GENSIA SICOR
INJECTIONApproved1/16/2001 
FLUOXETINE 40 MG

00P-1365/CP1
LACHMAN CONSULTANT SERVICES
TABLET; ORALApproved1/12/2001 
GABAPENTIN 100MG,300MG,400MG

00P-1419/CP1
LACHMAN CONSULTANT SERVICES
TABLET; ORALApproved1/12/2001 
CEFACLOR 500 MG

00P-1397/CP1
THE WEINBERG GROUP INC.
TABLET; CHEWABLEApproved4/17/2001 
ACETAMINOPHEN; 650 MG/ 30 ML
HYDROCODONE BITARTRATE 10 MG/30 ML
00P-1243/CP2
PHARMACEUTICAL ASSOCIATES INC.
SOLUTION; ORALDenied5/7/2001 
FAMOTIDINE 10MG

00P-1422/CP1
YAMANOUCHI PHARMA TECHNOLOGIES
TABLET; ORALLY DISINTEGRATINGApproved4/17/2001 
ACETAMINOPHEN; 650MG/30 ML
HYDROCODONE BITARTRATE 10MG/30ML
00P-1431/CP1
PHARMACEUTICAL ASSOCIATES INC
SOLUTION; ORALWithdrawn9/6/2000 
IOPAMIDOL

00P-1452/CP1
COOK IMAGING CORP.
INJECTIONApproved4/23/2001 
PHENYTOIN SODIUM 200 MG, 300 MG

00P-1462/CP1
LACHMAN CONSULTANT SERVICES
CAPSULE, EXTENDED RELEASE; ORALApproved2/13/2000 
SERTRALINE HYDROCHLORIDE 25MG, 50MG, 100MG

00P-1468/CP1
LACHMAN CONSULTANT SERVICES
CAPSULE; ORALApproved7/3/2002 
AMINO ACIDS 10% 1000mL & 2000mL

00P-1470/CP1
BAXTER HEALTHCARE CORP
INJECTIONApproved1/11/2001 
PROPOFOL 2%:20MG/ML:10ML,50ML

00P-1471/CP1
GENSIA SICOR PHARMACEUTICALS
INJECTIONDenied4/30/2001 
LEUCOVORIN CALCIUM 5 MG/ML - 100ML VIAL

00P-1518/CP1
PD REGULATORY SERVICES
INJECTIONWithdrawn2/14/2001 
PROPOXYPHENE NAPSYLATE; 50 MG
ACETAMINOPHEN 500 MG
00P-1551/CP1
ARNALL, GOLDEN & GREGORY
TABLET; ORALApproved1/16/2001 
PROPOXYPHENE NAPSYLATE; 100 MG
ACETAMINOPHEN 500 MG
00P-1551/CP2
ARNALL, GOLDEN & GREGORY
TABLET; ORALApproved1/16/2001 
URSODIOL 100 MG/5 ML

00P-1568/CP1
LACHMAN CONSULTANT SERVICES
SUSPENSION; ORALDenied7/9/2002 
POTASSIUM IODIDE 65 MG

00P-1574/CP1
R&R REGISTRATIONS
TABLET; ORALApproved7/25/2001 
CLADRIBINE 2 MG/ML - 5 ML VIAL

00P-1621/CP1
LIPOMED, INC.
INJECTIONDenied8/1/2001 
HYDROCODONE BITARTRATE; 10 MG/15 ML
ACETAMINOPHEN 325 MG/15ML
00P-1641/CP1
PHARMACEUTICAL ASSOCIATES INC.
SOLUTION; ORALApproved4/17/2001 
MERCAPTOPURINE 100 MG

00P-1645/CP1
McKENNA & CUNEO
TABLET; ORALApproved4/17/2001 
CARBAMAZEPINE 200 MG

01P-0028/CP1
TARO RESEARCH INSTITUTE LTD.
TABLET; CHEWABLEApproved5/8/2001 
CARBOPLATIN 50 MG/5 ML ;10MG/ML
150 MG/15 ML;10MG/ML
01P-0036/CP1
VENABLE
INJECTIONApproved11/30/2001 
MIDODRINE HYDROCHLORIDE 15 MG

01P-0081/CP1
LACHMAN CONSULTANT SERVICES
TABLET; ORALApproved5/8/2001 
HYDROCORTISONE ACETATE 2%

01P-0085/CP1
FERNDALE LABORATORIES INC.
CREAM; TOPICALApproved8/1/2001 
DOXYCYCLINE 75 MG

01P-0109/CP1
THE WEINBERG GROUP INC.
CAPSULE; ORALApproved8/2/2001 
POTASSIUM CHLORIDE 15 mEq

01P-0108/CP1
LACHMAN CONSULTANTS
TABLET; EXTENDED-RELEASE; ORALApproved7/9/2001 
AMIODARONE HYDROCHLORIDE 100 MG

01P-0125/CP1
OLSON, FRANK AND WEEDA, P.C.
TABLET; ORALApproved8/2/2001 
ACETAMINOPHEN; 650 MG/15 ML
HYDROCODONE BITARTRATE 10 MG/15 ML
01P-0130/CP1
PHARMACEUTICAL ASSOCIATES, INC
SOLUTION; ORALApproved8/20/2001 
MIDAZOLAM 5 MG/ML-10 ML VIALS

01P-0136/CP1
ABBOTT LABORATORIES
INJECTIONApproved8/5/2002 
ACETAMINOPHEN; 500 MG/15 ML
HYDOCODONE BITARTRATE 10 MG/15 ML
01P-0144/CP1
PHARMACEUTICAL ASSOCIATES INC.
SOLUTION; ORALApproved8/20/2001 
KETAMINE HYDROCHLORIDE 100 MG/ML-10ML VIALS

01P-0156/CP1
BIONICHE PHARMA GROUP
INJECTIONApproved8/20/2001 
PROPOXYPHENE NAPSYLATE; 100 mg
ACETAMINOPHEN 325 mg
01P-0186/CP1
ARNALL, GOLDEN & GREGORY
TABLET; ORALApproved8/20/2001 
ACETAMINOPHEN; 320 MG/10 ML
HYDROCODONE BITARTRATE 10 MG/10 ML
01P-0130/CP2
PHARMACEUTICAL ASSOCIATES, INC
SOLUTION; ORALDenied7/9/2002 
PROGESTERONE 100 MG & 200 MG

01P-0209/CP1
DURAMED
TABLET; ORALApproved7/3/2002 
ACETAMINOPHEN; 325 MG/15 ML
HYDROCODONE BITARTRATE 7.5 MG/15 ML
01P-0214/CP1
PHARMACEUTICAL ASSOCIATES
SOLUTION; ORALApproved8/20/2001 
PAROXETINE 20 MG & 40 MG

01P-0241/CP1
CIPHER PHARMACEUTICALS LTD.
CAPSULE; ORALWithdrawn2/12/2004 
SIMVASTATIN 10 MG & 40 MG

01P-0242/CP1
Cipher Pharmaceuticals, Ltd.
CAPSULE; ORALWithdrawn7/31/2001 
RAMIPRIL 2.5 MG & 10 MG

01P-0240/CP1
Cipher Pharmaceuticals Ltd.
CAPSULE; ORALWithdrawn7/31/2001 
FLUOXETINE 20 MG & 40 MG

01P-0243/CP1
CIPHER PHARMACEUTICALS LTD.
CAPSULE; ORALWithdrawn7/31/2001 
AMLODIPINE 5 MG & 10 MG

01P-0239/CP1
CIPHER PHARMACEUTICALS LTD.
CAPSULE; ORALWithdrawn2/12/2004 
ACETAMINOPHEN; 500 MG
HYDROCODONE BITARTRATE 10 MG
01P-0251/CP1
MALLINKRODT
SOLUTION; ORALWithdrawn8/23/2001 
PENTOXIFYLLINE 500 MG

01P-0283/CP1
THE WEINBERG GROUP, INC.
TABLET; EXTENDED-RELEASE; ORALDenied7/3/2002 
LIDOCAINE 5%

01P-0291/CP1
Ferndale Laboratories Inc.
CREAM; TOPICALDenied7/3/2002 
TESTOSTERONE 5%

01P-0302/CP1
Testocream LLC
GEL; TOPICALDenied4/12/2002 
FLUOROURACIL 2.5%

01P-0288/CP1
Ferndale Laboratories Inc.
SOLUTION; TOPICALApproved1/8/2002 
SODIUM TETRADECYL SULFATE 0.5% & 0.2%

01P-0351/CP1
Bennett and Company
INJECTIONDenied4/12/2002 
HYDROCORTISONE ACETATE 2.5%

01P-0355/CP1
FERNDALE LABORATORIES INC
SUSPENSION; TOPICALPending 
HYDROCODONE BITARTRATE 7.5 MG/15ML
ACETAMINOPHEN 325MG/15ML
01P-0374/CP1
LACHMAN CONSULTANT SERVICES
SOLUTION; ORALWithdrawn1/7/2002 
AZATHIOPRINE 75 MG & 100 MG

01P-0379/CP1
AAI INTERNATIONAL
TABLET; ORALApproved12/17/2001 
METHADONE HYDROCHLORIDE 15MG,20MG,30MG,40MG

01P-0377/CP1
LACHMAN CONSULTANT SERVICES IN
TABLET; ORALWithdrawn11/11/2002 
CARBIDOPA; 10MG & 25MG & 25MG
LEVODOPA 100MG & 100MG &250MG
01P-0358/CP1
THE WEINBERG GROUP, INC.
TABLET FOR ORAL SUSPENSIONApproved8/9/2002 
PROPOFOL 2000MG/200 ML

01P-0430/CP1
GENSIA SICOR
INJECTABLE EMULSIONPending 
GANCICLOVIR SODIUM 500 MG/10 ML

01P-0440/CP1
BEN VENUE LAOBRATORIES, INC.
INJECTIONPending2/3/2004 
HYDROCODONE BITARTRATE 10 MG
ACETAMINOPHEN 300 MG
01P-0441/CP1
LACHMAN CONSULTANT SERVICES
TABLET; ORALApproved12/20/2001 
HYDROCODONE BITARTRATE 10 MG
IBUPROFEN 200 MG
01P-0442/CP1
LACHMAN CONSULTANT SERVICES
TABLET; ORALApproved12/20/2001 
AMIODARONE 100 MG

01P-0445/CP1
TARO
TABLET; ORALWithdrawn10/16/2001 
DIGOXIN 0.05 MG/ML

01P-0449/CP1
ROXANE LABORATORIES INC.
SOLUTION; ORALWithdrawn12/20/2001 
ONDANSETRON HYDROCHLORIDE 16 MG

01P-0492/CP1
MCDERMOTT, WILL & EMERY
TABLET; ORALApproved4/12/2002 
HYDROCODONE BITARTRATE 10 MG, 7.5 MG
ACETAMINOPHEN 400 MG, 400 MG
01P-0504/CP1
SHOTWELL & CARR, INC.
TABLET; ORALWithdrawn1/2/2002 
DOXYCYCLINE 150 MG

01P-0516/CP1
LACHMAN CONSULTANT SERVICES
TABLET; ORALApproved4/12/2002 
HYDROCORTISONE ACETATE 2.5%

01P-0511/CP1
FERNDALE LABORATORIES, INC.
LOTION; TOPICALPending2/3/2004 
DOXYCYCLINE 75 MG

01P-0515/CP1
LACHMAN CONSULTANT SERVICES
TABLET; ORALApproved4/12/2002 
HYDROCODONE BITARTRATE 7.5 MG & 10 MG
ACETAMINOPHEN 250 MG & 250 MG
01P-0521/CP1
SHOTWELL & CARR, INC.
TABLET; ORALDenied7/3/2002 
HYDROCODONE BITARTRATE 10 MG/15 ML
ACETAMINOPHEN 300 MG/15 ML
01P-0524/CP1
LACHMAN CONSULTANT SERVICES
SOLUTION; ORALApproved8/6/2002 
CARISOPRODOL 200 MG

01P-0526/CP1
ATLEY PHARMACEUTICALS, INC.
TABLET; ORALDenied7/3/2002 
ACETAMINOPHEN 200MG;200MG; 200MG
HYDROCODONE BITARTRATE 5MG;7.5MG;10MG
02P-0004/CP1
SHOTWELL AND CARR, INC.
TABLET; ORALDenied3/17/2003 
CARBIDOPA 25 MG; 10 MG; 25 MG
LEVODOPA 100MG; 100MG; 250MG
02P-0033/CP1
LACHMAN CONSULTANT SERVICES
TABLETS; ORALLY DISINTEGRATINGApproved9/25/2002 
BUTALBITAL 25 MG, 50 MG
ACETAMINOPHEN 300 MG, 600 MG
02P-0056/CP1
SHOTWELL & CARR, INC.
TABLET; ORALApproved2/28/2003 
BACLOFEN 10 mg, 20 mg

02P-0078/CP1
KLEINFELD, KAPLAN & BECKER
ORALLY DISINTEGRATING TABLETSApproved2/3/2004 
OXYCODONE 5mg, 7.5mg, 10mg
ACETAMINOPHEN 300mg
02P-0105/CP1
LACHMAN CONSULTANT SERVICES
TABLETSApproved8/6/2002 
CARISOPRODOL 350 mg

02P-0138/CP1
LACHMAN CONSULTANT SERVICES
ORALLY DISINTEGRATING TABLETSWithdrawn7/25/2002 
ESTROPIPATE 1.2 mg

02P-0141/CP1
WOMEN FIRST HEALTHCARE
TABLETSApproved9/24/2002 
FENOFIBRATE 107 mg

02P-0148/CP1
LAVENDER CONSULTING SERVICES
TABLETSApproved9/25/2002 
ISOTRETINOIN 30 mg

02P-0161/CP1
LACHMAN CONSULTANT SERVICES
CAPSULESApproved8/8/2002 
LEVORPHANOL TARTRATE 1 mg, 3 mg

02P-0225/CP1
LACHMAN CONSULTANT SERVICES
TABLETSApproved10/16/2002 
METHOTREXATE SODIUM 5 mg/mL

02P-0226/CP1
KIRKPATRICK & LOCKHART LLP
ORAL SOLUTIONApproved2/3/2004 
HYDROCODONE BITARTRATE 5 mg
ACETAMINOPHEN 500 mg
02P-0233/CP1
KLEINFELD, KAPLAN AND BECKER
ORALLY DISINTEGRATING TABLETSApproved2/11/2004 
FLUDARABINE PHOSPHATE 25 mg/mL

02P-0245/CP1
GENSIA SICOR PHARMACEUTICALS
SOLUTION FOR INJECTIONApproved4/27/2004 
CLOZAPINE 50 mg

02P-0247/CP1
AAC CONSULTING GROUP
TABLETSApproved11/26/2002 
MIRTAZAPINE 7.5 mg

02P-0249/CP1
AAC CONSULTING GROUP
TABLETSApproved2/27/2003 
HYDROCODONE BITARTRATE 5 mg
IBUPROFEN 200 mg
02P-0270/CP1
SCIREGS CONSULTING
TABLETSApproved9/25/2002 
OXYCODONE HYDROCHLORIDE 15 mg, 20 mg
ACETAMINOPHEN 325 mg
02P-0285/CP1
KING & SPALDING
TABLETSDenied2/12/2003 
PROPOXYPHENE HYDROCHLORIDE 65 mg
ACETAMINOPHEN 389 mg
02P-0297/CP1
LACHMAN CONSULTANT SERVICES
CAPSULESDenied2/3/2004 
AMIODARONE HYDROCHLORIDE 50 MG/ ML 9 ML VIALS

02P-0346/CP1
GENSIA SICOR
INJECTIONApproved2/25/2003 
AMOXICILLIN 300 mg, 600 mg

02P-0358/CP1
THE WEINBERG GROUP
TABLETS FOR ORAL SUSPENSIONApproved11/26/2002 
LOPERAMIDE HYDROCHLORIDE 2 mg

02P-0380/CP1
BANNER PHARMACAPS
SOFT GELATIN CAPSULESWithdrawn6/7/2007 
LOPERAMIDE HYDROCHLORIDE 1 MG

02P-0424/CP1
BANNER PHARMACAPS
CAPSULE; ORALWithdrawn7/7/2007 
HYDROCODONE BITARTRATE 7.5 mg
IBUPROFEN 200 mg
02P-0386/CP1
PHARMACEUTICAL ASSOCIATES
ORAL SUSPENSIONWithdrawn2/3/2004 
AMIODARONE HYDROCHLORIDE 300 mg

02P-0394/CP1
TARO RESEARCH INSTITUTE
TABLETSApproved3/6/2003 
AMOXICILLIN 600mg
CLAVULANATE POTASSIUM 42.9mg
02P-0406/CP1
THE WEINBERG GROUP, INC.
TABLETS FOR ORAL SUSPENSIONDenied10/15/2004 
CEFUROXIME AXETIL 125mg and 250mg

02P-0414/CP1
THE WEINBERG GROUP, INC
TABLETS FOR ORAL SUSPENSIONDenied4/29/2004 
PROPOXYPHENE NAPSYLATE 100 mg
ACETAMINOPHEN 325 mg, 500 mg
02P-0422/CP1
FROMMER LAWRENCE & HAUG
ORAL TABLETSWithdrawn3/7/2003 
AMIODARONE HYDROCHLORIDE 50mg/mL, 18mL vial

02P-0419/CP1
BIONICHE PHARMA GROUP
INJECTIONWithdrawn4/22/2003 
RIBAVIRIN 200 MG

02P-0436/CP1
BIOPARTNERS
TABLETWithdrawn9/29/2004 
CEFPODOXIME PROXETIL 50 mg, 100 mg

02P-0444/CP1
THE WEINBERG GROUP
TABLETS FOR ORAL SUSPENSIONDenied6/7/2005 
ALBUTEROL SULFATE .083% (base)

02P-0448/CP1
SENSORMEDICS CORPORATION
INHALATION SOLUTIONDenied12/17/2003 
METOPROLOL TARTRATE 25 mg

02P-0460/CP1
CARACO PHARMACEUTICAL
TABLETSApproved2/13/2003 
METOPROLOL TARTRATE 25 mg

02P-0459/CP1
LACHMAN CONSULTANT SERVICES
TABLETSApproved2/13/2003 
OXYCODONE HYDROCHLORIDE 2.5 mg
ACETAMINOPHEN 300 mg
02P-0465/CP1
LACHMAN CONSULTANT SERVICES
TABLETSApproved2/13/2003 
NAPROXEN SODIUM 220 mg

02P-0473/CP1
BANNER PHARMACAPS
SOFT GELATIN CAPSULESWithdrawn4/13/2005 
FENTANYL 12.5 mcg/hr

02P-0478/CP1
LACHMAN CONSULTANT SERVICES
TRANSDERMAL SYSTEMWithdrawn10/14/2003 
AMIODARONE HYDROCHLORIDE 450 mg/9 mL

02P-0480/CP1
BIONICHE PHARMA GROUP
INJECTIONApproved2/25/2003 
METHADONE HYDROCHLORIDE 15mg, 20mg, 30mg

02P-0481/CP1
LACHMAN CONSULTANT SERVICES
TABLETS (DISPERSIBLE)Approved3/4/2003 
AMIODARONE HYDROCHLORIDE 300mg/6mL, 450mg/9mL

02P-0484/CP1
LACHMAN CONSULTANT SERVICES
INJECTIONApproved2/25/2003 
WARFARIN SODIUM 0.5 mg

02P-0498/CP1
TARO PHARMACEUTICALS
TABLETSApproved4/14/2003 
METFORMIN HYDROCHLORIDE 500mg, 850mg, 1000mg

02P-0499/CP1
THE WEINBERG GROUP
TABLETS FOR ORAL SOLUTIONApproved2/11/2004 
DIGOXIN 0.25 MG/5 ML

02P-0503/CP1
ROXANE LABORATORIES
ELIXIRWithdrawn 
URSODIOL 20 MG/ML

03P-0082/CP1
LACHMAN CONSULTANT SERVICES
ORAL SUSPENSIONWithdrawn2/3/2004 
CARBAMAZEPINE 100mg, 300mg, 400mg

03P-0083/CP1
TARO PHARMACEUTICALS
TABLETSApproved12/17/2003 
HYDROCODONE POLISTIREX 5 MG, 10 MG
CHLORPHENIRAMINE POLISTIREX 4 MG, 8 MG
03P-0091/CP1
LACHMAN CONSULTANT SERVICES
EXTENDED RELEASE CAPSULESApproved8/31/2004 
OXYCODONE HYDROCHLORIDE 15 MG, 20 MG
ACETAMINOPHEN 325 MG
02P-0285/PRC1
KING & SPALDING
TABLETSDenied7/30/2004 
OXYCODONE HYDROCHLORIDE 15 MG, 20 MG
ACETAMINOPHEN 325MG, 325 MG
02P-0285/PRC1
KING & SPALDING
TABLET; ORALDenied7/30/2004 
EPIRUBICIN HYDROCHLORIDE 10mg/ 5mL;150mg/75mL

03P-0110/CP1
FAULDING PHARMACEUTICAL CO.
INJECTIONApproved8/13/2003 
METHADONE HYDROCHLORIDE 15MG,20MG,30MG,40MG

03P-0119/CP1
LACHMAN CONSULTANT SERVICES
TABLETS USPPending5/13/2003 
VENLAFAXINE HYDROCHLORIDE 37.5MG, 75MG, 150MG

03P-0159/CP1
LACHMAN CONSULTANT SERVICES
EXTENDED RELEASE TABLETSApproved3/30/2005 
DIVALPROEX SODIUM 1000 MG

03P-0178/CP1
LACHMAN CONSULTANT SERVICES
EXTENDED RELEASE TABLETSApproved8/18/2003 
NAFCILLIN SODIUM 200 GRAM

03P-0184/CP1
SAMSON MEDICAL TECHNOLOGIES
INJECTIONApproved8/18/2003 
GLYBURIDE 1.25mg, 2.5mg, 5mg
METFORMIN HYDROCHLORIDE 250mg, 500mg, 500mg
03P-0188/CP1
THE WEINBERG GROUP
TABLETS FOR ORAL SOLUTIONApproved7/30/2004 
LEVONORGESTREL 1.5 MG

03P-0216/CP1
HRA PHARMA
TABLETDenied12/17/2003 
CARBOPLATIN 600 MG/60 ML

03P-0220/CP1
FAULDING
INJECTIONDenied2/3/2004 
GLIPIZIDE 2.5 MG, 5 MG
METFORMIN HYDROCHLORIDE 250 MG, 500 MG
03P-0218/CP1
THE WEINBERG GROUP
TABLETS FOR ORAL SOLUTIONApproved7/30/2004 
CEFOXITIN 100 GRAM, 300 GRAM

03P-0227/CP1
SAMSON MEDICAL TECHNOLOGIES
INJECTIONApproved10/1/2003 
PROPRANOLOL HYDROCHLORIDE 60, 80, 120, 160 MG

03P-0237/CP1
URL MUTUAL
EXTENDED-RELEASE TABLETSApproved2/3/2004 
CLARITHROMYCIN 1000 MG

03P-0238/CP1
THE WEINBERG GROUP
EXTENDED-RELEASE TABLETSApproved12/18/2003 
FLUOCINOLONE ACETONIDE 0.01%
HYDROQUINONE 4%
03P-0279/CP1
JERUSSI CONSULTING
TOPICAL SOLUTIONDenied4/1/2005 
GLIMEPIRIDE 8 MG

03P-0283/CP1
LACHMAN CONSULTANT SERVICES
TABLETSApproved10/6/2003 
CEFTAZIDIME 100GM PHARM BULK PKG

03P-0292/CP1
SAMSON MEDICAL TECHNOLOGIES
INJECTIONApproved12/23/2003 
DICLOFENAC POTASSIUM 25 MG

03P-0298/CP1
THE WEINBERG GROUP
CAPSULESWithdrawn2/3/2004 
WARFARIN SODIUM 1.5 MG

03P-0307/CP1
TARO PHARMACEUTICALS
TABLETSApproved10/6/2003 
CARBAMAZEPINE 200 MG/5 ML

03P-0304/CP1
TARO PHARMACEUTICALS
ORAL SUSPENSIONDenied1/16/2013 
HYDROCODONE BITARTRATE 5 MG, 7.5 MG, 10 MG
IBUPROFEN 400 MG
03P-0331/CP1
LACHMAN CONSULTANT SERVICES
TABLETSDenied4/1/2005 
HYDROQUINONE 4%
TRETINOIN 0.01%
03P-0365/CP1
JERUSSI CONSULTING
TOPICAL SOLUTIONDenied12/2/2004 
HYDROCODONE BITARTRATE 5 MG
BUTALBITAL 50 MG
03P-0398/CP1
INTN'L REGULATORY BUSINESS
CAPSULEWithdrawn 
METFORMIN HYDROCHLORIDE 1000 MG

03P-0388/CP1
LACHMAN CONSULTANT SERVICES
EXTENDED RELEASE TABLETSApproved12/23/2003 
HYDROCODONE BITARTRATE 5 MG
ACETAMINOPHEN 300 MG
03P-0414/CP1
LACHMAN CONSULTANT SERVICES
TABLETApproved11/23/2004 
HYDROCODONE BITARTRATE 7.5 MG
ACETAMINOPHEN 300 MG
03P-0413/CP1
LACHMAN CONSULTANT SERVICES
TABLETApproved9/28/2004 
HYDROCODONE BITARTRATE 5 MG, 7.5MG & 10 MG
ACETAMINOPHEN 300 MG,300 MG&300 MG
03P-0436/CP1
ANABOLIC LABORATORIES, INC.
TABLET; ORALApproved10/10/2003 
METOPROLOL TARTRATE 12.5 MG

03P-0441/CP1
NABEAL M. SAIF
TABLETSDenied10/15/2004 
KETOPROFEN; 12.5 MG
HYDROCODONE BITARTRATE 7.5 MG
03P-0453/CP1
KING & SPALDING LLP
TABLETDenied3/15/2006 
CYCLOBENZAPRINE HYDROCHLORIDE 7.5 MG

03P-0461/CP1
ANABOLIC LABORATORIES
TABLET; ORALApproved10/15/2004 
CARISOPRODOL 200 MG
ACETAMINOPHEN 325 MG
03P-0460/CP1
ANABOLIC LABORATORIES, INC.
TABLET; ORALPending2/4/2004 
CLONAZEPAM 1 MG/5 ML

03P-0464/CP1
LACHMAN CONSULTANT SERVICES
ORAL SUSPENSIONApproved10/17/2005 
HYDROCODONE BITARTRATE 5 MG
ACETAMINOPHEN 325 MG
03P-0475/CP1
INT'L REGULATORY BUSINESS CONS
LIQUID; ORALWithdrawn2/4/2004 
ACETAMINOPHEN 770 MG, 385 MG
CAFFEINE 60 MG, 30 MG
03P-0505/CP1
LACHMAN CONSULTANT SERVICES
TABLETWithdrawn10/19/2004 
ONDANSETRON HYDROCHLORIDE 8, 12, 16, 20, 24MG
IN 50 ML 5% DEXTROSE
03P-0519/CP1
ABBOTT LABORATORIES
INJECTIONWithdrawn4/12/2004 
GLYBURIDE 1.25MG, 2.5MG, 5 MG
METFORMIN HYDROCHLORIDE 250MG, 500MG,
03P-0534/CP1
LACHMAN CONSULTANT SERVICES
ORAL SOLUTIONApproved7/30/2004 
CITALOPRAM HYDROBROMIDE 10 MG, 20 MG, 40 MG

03P-0551/CP1
FROMMER LAWRENCE & HAUG
CAPSULEApproved3/29/2005 
DIHYDROERGOTAMINE MESYLATE 2 MG/ML

03P-0556/CP1
HYMAN, PHELPS & MCNAMARA
INJECTIONDenied4/1/2005 
ONDANSETRON HYDROCHLORIDE 8 MG/4 ML

04P-0048/CP1
ABBOTT LABORATORIES
INJECTIONWithdrawn4/12/2004 
DOXYCYCLINE HYCLATE 75 MG, 100 MG

04P-0054/CP1
URL MUTUAL
CAPSULESWithdrawn4/12/2004 
ONDANSETRON 16 MG, 24 MG

04P-0056/CP1
LACHMAN CONSULTANT SERVICES
ORALLY DISINTEGRATING TABLETSApproved7/7/2004 
FENTANYL 37.5 mcg/hr
62.5 mcg/hr
04P-0069/CP1
LACHMAN CONSULTANT SERVICES
TRANSDERMAL SYSTEMApproved7/7/2004 
ESMOLOL HYDROCHLORIDE 2500 MG/VIAL

04P-0085/CP1
BEDFORD LABORATORIES
INJECTIONDenied6/7/2005 
POTASSIUM IODIDE 65 MG/ML

04P-0092/CP1
RRD INTERNATIONAL
ORAL SOLUTIONApproved3/3/2004 
GLIMEPIRIDE 3 MG, 6 MG

04P-0123/CP1
LACHMAN CONSULTANT SERVICES
TABLETSApproved7/7/2004 
SERTRALINE HYDROCHLORIDE 150 MG, 200 MG

04P-0125/CP1
LACHMAN CONSULTANT SERVICES
TABLETSWithdrawn4/12/2004 
TOBRAMYCIN 100 MG/ML

04P-0131/CP1
SOURCE CF
SOLUTION FOR INHALATIONPending3/29/2004 
OXYCODONE HYDROCHLORIDE 7.5 MG, 10.0 MG
ACETAMINOPHEN 325 MG
04P-0150/CP1
ENDO PHARMACEUTICALS
ORALLY DISINTEGRATING TABLETSWithdrawn5/4/2006 
OXYCODONE HYDROCHLORIDE 2.5 MG, 5 MG
ACETAMINOPHEN 325 MG
04P-0149/CP1
ENDO PHARMACEUTICALS
ORALLY DISINTEGRATING TABLETSWithdrawn5/4/2006 
OXYCODONE HYDROCHLORIDE 5 MG, 10 MG, 20 MG

04P-0148/CP1
THE WEINBERG GROUP
TABLETSApproved9/28/2004 
HYDROMORPHONE HYDROCHLORIDE 2 MG, 4 MG

04P-0152/CP1
THE WEINBERG GROUP
TABLETSApproved9/28/2004 
OXYCODONE HYDROCHLORIDE 5, 10, 15, 20, 30 MG

04P-0153/CP1
THE WEINBERG GROUP
CAPSULESDenied5/17/2005 
AMOXICILLIN 200 MG, 400 MG
CLAVULANATE POTASSIUM 28.5 MG, 57 MG
04P-0157/CP1
THE WEINBERG GROUP
TABLETS FOR ORAL SUSPENSIONApproved9/28/2006 
GLIPIZIDE 2.5 mg, 5 mg
METFORMIN HYDROCHLORIDE 250mg/5mL;500mg/10mL
04P-0168/CP1
LACHMAN CONSULTANT SERVICES
ORAL SOLUTIONApproved11/23/2004 
CEFPROZIL 125 MG, 250 MG

04P-0173/CP1
LACHMAN CONSULTANT SERVICES
TABLETS FOR ORAL SUSPENSIONDenied6/7/2005 
RIBAVIRIN 400 MG, 600 MG

04P-0196/CP1
FROMMER LAWRENCE & HAUG
TABLETSApproved9/28/2004 
DIVALPROEX SODIUM 750 MG

04P-0195/CP1
LACHMAN CONSULTANT SERVICES
EXTENDED RELEASE TABLETSApproved9/28/2004 
GLIPIZIDE 2.5 MG, 5 MG
METFORMIN HYDROCHLORIDE 250 MG, 500 MG
04P-0208/CP1
THE WEINBERG GROUP
TABLETS FOR ORAL SUSPENSIONApproved11/23/2004 
GLYBURIDE 1.25 MG, 2.5 MG, 5MG
METFORMIN HYDROCHLORIDE 250 MG, 500 MG
04P-0209/CP1
THE WEINBERG GROUP
TABLETS FOR ORAL SUSPENSIONApproved11/23/2004 
DOXYCYCLINE 150 MG

04P-0219/CP1
LACHMAN CONSULTANT SERVICES
CAPSULESApproved9/28/2004 
PRAVASTATIN SODIUM 30 MG

04P-0216/CP1
LACHMAN CONSULTANT SERVICES
TABLETSApproved9/28/2004 
PRAVASTATIN SODIUM 60 MG

04P-0213/CP1
LACHMAN CONSULTANT SERVICES
TABLETSApproved9/28/2004 
CIPROFLOXACIN HYDROCHLORIDE 0.4 ML UNIT DOSE

04P-0222/CP1
STRADLING YOCCA CARLSON & RAUT
OPHTHALMIC SOLUTIONApproved11/18/2009 
OXYCODONE 2.5, 5, 7.5, 10 MG
ACETAMINOPHEN 400 MG
04P-0243/CP1
LACHMAN CONSULTANT SERVICES
TABLETSWithdrawn6/10/2004 
ESCITALOPRAM OXALATE 10 MG, 20 MG

04P-0247/CP1
FROMMER LAWRENCE & HAUG
CAPSULEApproved3/29/2005 
HYDROCODONE BITARTRATE 5 MG, 7.5 MG, 10 MG
ACETAMINOPHEN 700 MG
04P-0252/CP1
LACHMAN CONSULTANT SERVICES
TABLETSApproved10/17/2005 
CEFUROXIME AXETIL 125 MG, 250 MG

02P-0414/PRC
THE WEINBERG GROUP
TABLETS FOR ORAL SUSPENSIONDenied2/19/2013 
CEFIXIME 100MG, 150MG, 200MG

04P-0263/CP1
LUPIN PHARMACEUTICALS
CHEWABLE TABLETSApproved10/6/2005 
NICOTINE POLACRILEX 2 MG/240 ML
4 MG/240 ML
04P-0280/CP1
NICO WORLDWIDE, LLC
ORAL SOLUTIONDenied5/26/2005 
NICOTINE BITARTRATE 2 MG/240 ML
4 MG/240 ML
04P-0282/CP1
NICO WORLDWIDE, LLC
ORAL SOLUTIONDenied10/29/2010 
NICOTINE BASE 2 MG/240 ML
4 MG/240 ML
04P-0281/CP1
NICO WORLDWIDE, LLC
ORAL SOLUTIONDenied10/29/2010 
BENZONATATE 150 MG

04P-0321/CP1
LACHMAN CONSULTANT SERVICES
CAPSULESApproved11/23/2004 
ADENOSINE 18 MG/6 ML
30 MG/10 ML
04P-0326/CP1
APOTEX CORPORATION
INJECTIONDenied8/22/2007 
FAMOTIDINE 10 MG

04P-0353/CP1
LACHMAN CONSULTANT SERVICES
ORALLY DISSOLVING STRIPSApproved7/5/2005 
METHACHOLINE CHLORIDE 1280 MG/VIAL

04P-0359/CP1
METHAPHARM
ORAL INHALATIONWithdrawn3/21/2006 
SODIUM FERRIC GLUCONATE 10 ML/125 MG
COMPLEX IN SUCROSE
04P-0360/CP1
AAC CONSULTING
INJECTIONApproved3/15/2006 
OMEPRAZOLE MAGNESIUM 20 MG BASE

04P-0373/CP1
GRAY CARY
DELAYED RELEASE CAPSULEApproved7/5/2005 
DOXYCYCLINE HYCLATE 75 MG, 100 MG

04P-0390/CP1
LACHMAN CONSULTANT SERVICES
TABLETSPending9/21/2004 
METOCLOPRAMIDE HYDROCHLORIDE 5 MG, 10 MG

04P-0409/CP1
LACHMAN CONSULTANT SERVICES
ORALLY DISINTEGRATING TABLETSWithdrawn10/17/2005 
TRAMADOL HYDROCHLORIDE 50 MG PER 5 ML

04P-0405/CP1
LACHMAN CONSULTANT SERVICES
ORAL SOLUTIONDenied7/28/2005 
ATORVASTATIN CALCIUM 10MG/20MG/40MG/80MG

04P-0418/CP1
LACHMAN CONSULTANT SERVICES
CAPSULESWithdrawn7/1/2005 
FLUCONAZOLE 100 MG/50 ML

04P-0434/CP1
BEN VENUE LABORATORIES
INJECTIONApproved8/18/2006 
CARBINOXAMINE MALEATE 4 MG

04P-0451/CP1
NUTEC INCORPORATED
CHEWABLE TABLETPending10/8/2004 
MEPERIDINE HYDROCHLORIDE 75 MG, 150 MG

04P-0500/CP1
LACHMAN CONSULTANT SERVICES
TABLETSApproved3/31/2005 
METHACHOLINE CHLORIDE 1280 MG/VIAL

04P-0511/CP1
ACIC FINE CHEMICALS, INC.
POWDER, METEREDWithdrawn3/21/2006 
SELEGILINE HYDROCHLORIDE 5 MG

04P-0514/CP1
LACHMAN CONSULTANT SERVICES
ORALLY DISINTEGRATING TABLETSWithdrawn1/11/2012 
TERBUTALINE SULFATE 1 MG/ML
25 ML PHARMACY BULK
04P-0518/CP1
BEN VENUE
INJECTIONPending 
CHLORHEXIDINE GLUCONATE 2%
ISOPROPOL ALCOHOL 70%
04P-0528/CP1
CARDINAL HEALTH
SOLUTION; TOPICALPending12/6/2004 
ONDANSETRON HYDROCHLORIDE 8 MG/4 ML

04P-0544/CP1
OLSSON, FRANK AND WEEDA
INJECTIONDenied6/19/2012 
ACETAMINOPHEN 300 MG
BUTALBITAL 50 MG
04P-0561/CP1
LACHMAN CONSULTANT SERVICES
CAPSULESApproved3/31/2005 
ACETAMINOPHEN 300 MG
BUTALBITAL 50 MG
04P-0560/CP1
LACHMAN CONSULTANT SERVICES
CAPSULESApproved3/31/2005 
RISPERIDONE 0.25 MG

05P-0007/CP1
LACHMAN CONSULTANT SERVICES
ORALLY DISINTEGRATING TABLETSApproved3/31/2005 
BUMETANIDE 6.25 MG/25 ML

05P-0006/CP1
BEN VENUE LABORATORIES
INJECTIONPending1/18/2005 
CEFIXIME 200 MG/5 ML

05P-0013/CP1
LUPIN PHARMACEUTICALS
ORAL SUSPENSIONApproved4/8/2005 
CHLORZOXAZONE 375 MG

05P-0044/CP1
LACHMAN CONSULTANT SERVICES
TABLETSApproved4/8/2005 
COLISTIMETHATE SODIUM 150 MG/2 ML

05P-0050/CP1
PRG CONSULTING
SOLUTIONApproved10/17/2005 
HYDROCHLOROTHIAZIDE 12.5 MG

05P-0060/CP1
LACHMAN CONSULTANT SERVICES
TABLETSApproved4/8/2005 
AMLODIPINE BESYLATE 2.5 MG, 5 MG, 10 MG

05P-0066/CP1
DLA PIPER RUDNICK GRAY CARY
CAPSULESDenied6/7/2006 
CALCITONIN, SALMON 2500 IU/0.25 MG

05P-0070/CP1
LATHAM & WATKINS
TABLET OR CAPSULEDenied6/2/2006 
CHLORHEXIDINE GLUCONATE 2%
ISOPROPYL ALCOHOL 70%
05P-0074/CP1
APLICARE INC.
TOPICAL SOLUTIONPending4/8/2005 
PREDNISOLONE SODIUM PHOSPHATE 10MG/5ML; 20MG/5ML;
25MG/5ML
05P-0080/CP1
LACHMAN CONSULTANT SERVICES
SOLUTIONApproved4/8/2005 
EDETATE DISODIUM

05P-0085/CP1
MCGUFF PHARMACEUTICALS
INJECTIONPending2/23/2005 
CEFTRIAXONE 100 GRAM

05P-0114/CP1
SAMSON MEDICAL TECHNOLOGIES
INJECTIONApproved7/14/2005 
OXYCODONE HYDROCHLORIDE 7.5 MG

05P-0140/CP1
LACHMAN CONSULTANT SERVICES
TABLETSApproved7/14/2005 
OXYCODONE HYDROCHLORIDE 20 MG/ML

05P-0144/CP1
THE WEINBERG GROUP
ORAL SOLUTIONDenied3/28/2006 
BACLOFEN 10 MG/5 ML

05P-0156/CP1
PHASE V PHARMACEUTICALS
ORAL SOLUTIONWithdrawn7/18/2005 
DIPHENOXYLATE HYDROCHLORIDE 5 MG
ATROPINE SULFATE 0.05 MG/5 ML
05P-0162/CP1
LACHMAN CONSULTANT SERVICES
ORAL SOLUTIONDenied12/10/2008 
DIPHENOXYLATE HYDROCHLORIDE 5 MG
ATROPINE SULFATE 0.05 MG
05P-0161/CP1
LACHMAN CONSULTANT SERVICES
TABLETSDenied12/10/2008 
VENLAFAXINE HYDROCHLORIDE 37.5MG, 75MG, 150MG

03P-0159/PRC1
COVINGTON & BURLING
TABLET; EXTENDED-RELEASE; ORALWithdrawn6/10/2009 
VENLAFAXINE HYDROCHLORIDE 37.5MG, 75MG, 150MG

03P-0159/PSA1
COVINGTON & BURLING
TABLET; EXTENDED-RELEASE; ORALWithdrawn6/10/2009 
CEFDITOREN PIVOXIL 400 MG

05P-0176/CP1
LACHMAN CONSULTANT SERVICES
TABLETSApproved7/14/2005 
RIBAVIRIN USP 500 MG

05P-0179/CP1
KILPATRICK STOCKTON
TABLETSApproved7/14/2005 
HYDROCODONE BITARTRATE 2.5 MG
IBUPROFEN 200 MG
05P-0180/CP1
LACHMAN CONSULTANT SERVICES
TABLETSApproved7/14/2005 
LAMOTRIGINE 50 MG; 250 MG

05P-0212/CP1
PHARMACEUTICAL PATENT ATTORNEY
TABLETSWithdrawn7/1/2005 
OXYCODONE HYDROCHLORIDE 30 MG, 60 MG

05P-0225/CP1
THE WEINBERG GROUP
TABLET; CONTROLLED-RELEASE; ORALApproved7/15/2005 
CHLORHEXIDINE GLUCONATE 2% W/V
ISOPROPYL ALCOHOL 70% V/V
05P-0226/CP1
APLICARE
PREOPERATIVE SKIN PREPPending6/17/2005 
RANITIDINE HYDROCHLORIDE 15 MG BASE/ML

05P-0228/CP1
LACHMAN CONSULTANT SERVICES
SUSPENSIONWithdrawn5/24/2006 
LIDOCAINE HYDROCHLORIDE 2%

05P-0243/CP1
INT. INST. FOR CLIN. RESEARCH
TOPICAL (SPRAY)Pending1/17/2006 
VANCOMYCIN HYDROCHLORIDE 100 GRAM VIAL

05P-0242/CP1
SAMSON MEDICAL TECHNOLOGIES
FOR INJECTIONApproved4/19/2006 
METHYLPHENIDATE HYDROCHLORIDE 72 MG

05P-0257/CP1
THE WEINBERG GROUP
TABLET; EXTENDED-RELEASE; ORALApproved11/14/2005 
WARFARIN SODIUM 1 MG/ML

05P-0307/CP1
MORTON GROVE PHARMACEUTICALS
ORAL SOLUTIONPending8/9/2005 
URSODIOL 20 MG/ML

05P-0315/CP1
CANREG
ORAL SUSPENSIONPending8/19/2005 
LOSARTAN POTASSIUM 10 MG/ML

05P-0351/CP1
MORTON GROVE
ORAL SOLUTIONDenied9/25/2007 
CARBOPLATIN 1000 MG/100 ML
MULTIPLE DOSE VIAL
05P-0398/CP1
LACHMAN CONSULTANT SERVICES
INJECTIONApproved9/29/2009 
BENZPHETAMINE HYDROCHLORIDE 25 MG, 50 MG

05P-0406/CP1
LACHMAN CONSULTANT SERVICES
CAPSULESApproved6/27/2007 
EFAVIRENZ 50 MG/100 MG/200 MG

05P-0407/CP1
LACHMAN CONSULTANT SERVICES
TABLETS FOR ORAL SUSPENSIONWithdrawn1/11/2010 
TRETINOIN 0.0375%, 0.075%

05P-0417/CP1
TRIAX PHARMACEUTICALS
CREAMApproved5/9/2007 
DEXTROAMPHETAMINE SULFATE 2.5 MG, 7.5 MG,
15 MG, 20 MG, 30 MG
05P-0418/CP1
LACHMAN CONSULTANT SERVICES
TABLETSWithdrawn11/1/2005 
RAMIPRIL 1.25 MG, 2.5 MG
5 MG AND 10 MG
05P-0460/CP1
LACHMAN CONSULTANT SERVICES
TABLETSWithdrawn11/3/2009 
RAMIPRIL 1.25MG, 2.5MG, 5MG,
10MG
05P-0472/CP1
PHARMACEUTICAL PATENT ATTORNEY
TABLETSPending11/28/2005 
MELOXICAM 7.5MG, 15MG

05P-0480/CP1
CAMARGO PHARMACEUTICAL SERVICE
ORALLY DISINTEGRATING TABLETSPending12/5/2005 
IRINOTECAN HYDROCHLORIDE 500 MG/25 ML

05P-0496/CP1
MAYNE PHARMA
INJECTIONApproved1/16/2007 
OXYCODONE HYDROCHLORIDE 10 MG/5 ML
ACETAMINOPHEN 300 MG/5 ML
06P-0007/CP1
LACHMAN CONSULTANT SERVICES
ORAL SOLUTIONApproved1/16/2007 
METHOCARBAMOL 1000 MG

06P-0002/CP1
LACHMAN CONSULTANT SERVICES
TABLETSApproved12/3/2010 
PREDNISOLONE SODIUM PHOSPHATE 10 MG/5 ML

06P-0072/CP1
OLSSON, FRANK AND WEEDA
ORAL SOLUTIONWithdrawn4/11/2006 
RAMIPRIL 1.25, 2.50, 5, 10 MG

06P-0084/CP1
KING & SPALDING
TABLETSWithdrawn2/1/2010 
BUTALBITAL 50 MG
ACETAMINOPHEN 300 MG
06P-0086/CP1
LACHMAN CONSULTANT SERVICES
TABLETSApproved8/18/2006 
PROPOXYPHENE NAPSYLATE 50 MG, 100 MG
ACETAMINOPHEN 300 MG
06P-0087/CP1
LACHMAN CONSULTANT SERVICES
TABLETSApproved12/18/2008 
PIPERACILLIN 12 GRAMS
TAZOBACTAM 1.5 GRAMS
06P-0095/CP1
SANDOZ
INJECTIONApproved5/6/2011 
LOPERAMIDE HYDROCHLORIDE 2 MG

06P-0098/CP1
MONOSOL RX
ORALLY DISSOLVING STRIPWithdrawn5/10/2006 
TEMAZEPAM 7.5 MG, 15 MG
22.5 MG AND 30 MG
06P-0103/CP1
LACHMAN CONSULTANT SERVICES
ORALLY DISINTEGRATING TABLETSPending3/21/2006 
OMEPRAZOLE 20 MG

06P-0117/CP1
QPHARMA, LLC
DELAYED-RELEASE TABLET; ORALPending3/15/2006 
CETIRIZINE HYDROCHLORIDE 5 MG, 10 MG

06P-0122/CP1
LACHMAN CONSULTANT SERVICES
ORALLY DISINTEGRATING TABLETSWithdrawn1/6/2012 
EPIRUBICIN HYDROCHLORIDE 2 MG/ML
10 MG/5 ML
06P-0131/CP1
AAC CONSULTING
INJECTIONPending4/11/2006 
GEMCITABINE 2 GM/VIAL

06P-0145/CP1
LACHMAN CONSULTANT SERVICES
INJECTIONApproved8/22/2007 
OXYCODONE 2.5 MG, 5 MG
ACETAMINOPHEN 325 MG
06P-0167/CP1
ARNALL GOLDEN GREGORY
ORALLY DISINTEGRATING TABLETPending4/26/2006 
OXYCODONE 7.5 MG, 10 MG
ACETAMINOPHEN 325 MG
06P-0167/CP2
ARNALL GOLDEN GREGORY
ORALLY DISINTEGRATING TABLETPending4/26/2006 
METHOTREXATE 100 MG/ML

06P-0177/CP1
SICOR PHARMACEUTICALS
INJECTIONWithdrawn3/23/2007 
LORATADINE 10 MG

06P-0208/CP1
STRIDES
CAPSULES, SOFT GELATINWithdrawn2/1/2010 
CETIRIZINE HYDROCHLORIDE 5 MG; 10 MG

06P-0207/CP1
STRIDES
CAPSULES, SOFT GELATINWithdrawn2/1/2010 
LIDOCAINE HYDROCHLORIDE 12 MG

06P-0230/CP1
ODAN LABORATORIES
ORAL NON-AEROSOL SPRAYPending6/15/2006 
LOPERAMIDE HYDROCHLORIDE 2 MG

06P-0253/CP1
AAC CONSULTING
ORALLY DISSOLVING STRIPPending7/5/2006 
CEFDINIR 187.5, 250, 300 MG

06P-0265/CP1
LUPIN PHARMACEUTICALS
CHEWABLE TABLETSPending7/5/2006 
DEXTROAMPHETAMINE SULFATE 2.5 MG, 7.5 MG
15 MG, 20 MG, 30 MG
06P-0267/CP1
LACHMAN CONSULTANT SERVICES
TABLETSApproved3/20/2007 
SODIUM CHLORIDE 3 ML, 5 ML,
15 ML, 30 ML
06P-0272/CP1
BECKLOFF ASSOCIATES
INJECTIONApproved8/22/2007 
WATER FOR INJECTION 3 ML, 5 ML, 15 ML
30 ML
06P-0273/CP1
BECKLOFF ASSOCIATES
INJECTIONApproved8/22/2007 
ALPRAZOLAM 0.25 MG

06P-0288/CP1
BECKLOFF ASSOCIATES
ORALLY DISINTEGRATING TABLETSPending8/1/2006 
GLYCOPYRROLATE 1.5 MG

06P-0300/CP1
LACHMAN CONSULTANT SERVICES
TABLETSApproved3/20/2007 
SODIUM CHLORIDE 0.9%, 1 ML SYRINGE

06P-0302/CP1
BECKLOFF ASSOCIATES
INJECTIONApproved8/22/2007 
LOPERAMIDE HYDROCHLORIDE 2 MG

06P-0305/CP1
MONOSOL RX
ORALLY DISSOLVING STRIPSPending8/10/2006 
ALCLOMETASONE DIPROPIONATE 0.05%

06P-0369/CP1
KIRKPATRICK & LOCKHART
LOTION; TOPICALWithdrawn1/6/2012 
CLOBETASOL PROPIONATE 0.05%

06P-0387/CP1
PADDOCK LABORATORIES
FOAMPending9/21/2006 
METOPROLOL TARTRATE 12.5 MG

06P-0395/CP1
KENDLE INTERNATIONAL
TABLETSWithdrawn8/27/2008 
FEXOFENADINE HYDROCHLORIDE 30 MG/5 ML
60 MG/5 ML
06P-0397/CP1
LUPIN PHARMACEUTICALS
ORAL SUSPENSIONPending10/6/2006 
DOXYCYCLINE (MONOHYDRATE) 125 MG

06P-0417/CP1
LACHMAN CONSULTANT SERVICES
TABLETSPending10/24/2006 
BETAMETHASONE VALERATE 0.12%

06P-0438/CP1
OLSSON, FRANK AND WEEDA
NON-AEROSOL FOAMPending11/7/2006 
CEFEPIME INTRAVENOUS ONLY

06P-0461
B. BRAUN
INJECTIONWithdrawn8/15/2008 
IBUPROFEN POTASSIUM 200 MG
PHENYLEPHRINE HYDROCHLORIDE 10 MG
06P-0469/CP1
STRIDES
CAPSULESPending11/28/2006 
POTASSIUM CHLORIDE 10%, 20%

06P-0477/CP1
KING & SPALDING
ORAL SOLUTIONPending12/11/2006 
OXYCODONE HYDROCHLORIDE 5 MG

06P-0481/CP1
ACTAVIS TOTOWA
CAPSULESPending12/11/2006 
PROPOXYPHENE NAPSYLATE 100 MG
ACETAMINOPHEN 400 MG
06P-0503/CP1
LACHMAN CONSULTANT SERVICES
TABLETSApproved3/5/2009 
URSODIOL 100, 200, 400 MG

06P-0505/CP1
LACHMAN CONSULTANT SERVICES
CAPSULESApproved8/28/2007 
METHOTREXATE 1000 MG/ML
10 ML VIAL
06P-0507/CP1
SICOR PHARMACEUTICALS
INJECTIONPending1/11/2007 
PROPOXYPHENE HYDROCHLORIDE 65 MG
ACETAMINOPHEN 325 MG
06P-0510/CP1
LACHMAN CONSULTANTS
TABLETSApproved3/5/2009 
VANCOMYCIN HYDROCHLORIDE 750 MG

06P-0534/CP1
KING ANS SPALDING
INJECTIONApproved8/22/2007 
VANCOMYCIN HYDROCHLORIDE 750 MG

06P-0533/CP1
KING & SPALDING
INJECTIONApproved8/22/2007 
FENTANYL CITRATE 1000 MCG, 1400 MCG

07P-0022/CP1
LACHMAN CONSULTANT SERVICES
ORAL TRANSMUCOSALApproved5/9/2011 
ACETAMINOPHEN 400 MG
BUTALBITAL 50 MG
07P-0030/CP1
LACHMAN CONSULTANT SERVICES
CAPSULESApproved6/9/2008 
LORATADINE 5 MG, 10 MG

07P-0037/CP1
LACHMAN CONSULTANT SERVICES
ORALLY-DISSOLVING STRIPSPending2/6/2007 
ZOLPIDEM TARTRATE 5 MG, 10 MG

07P-0042/CP1
LACHMAN CONSULTANT SERVICES
ORALLY DISSOLVING STRIPSWithdrawn6/1/2009 
ONDANSETRON 4 MG, 8 MG
16 MG, 24 MG
07P-0043/CP1
LACHMAN CONSULTANT SERVICES
ORALLY DISSOLVING STRIPSWithdrawn4/30/2009 
CIPROFLOXACIN HYDROCHLORIDE 100 MG, 250 MG
500 MG, 750 MG
07P-0100/CP1
JRRAPOZA ASSOCIATES
CAPSULESPending4/4/2007 
BISOPROLOL FUMARATE 5 MG, 10 MG, 20 MG
HYDROCHLOROTHIAZIDE 12.5 MG
07P-0071/CP1
LACHMAN CONSULTANT SERVICES
TABLETSDenied10/8/2013 
METOPROLOL TARTRATE 37.5 MG, 75 MG

07P-0072/CP1
LACHMAN CONSULTANT SERVICES
TABLETSApproved3/18/2010 
PROMETHAZINE HYDROCHLORIDE 6.25 MG
HYDROCODONE BITARTRATE 2.5 MG, 1.67 MG
07P-0076/CP1
SOVEREIGN PHARMACEUTICALS
SYRUPPending3/15/2007 
CARVEDILOL PHOSPHATE 10, 20, 40, 80 MG

07P-0103/CP1
KELLER AND HECKMAN
TABLET; EXTENDED-RELEASE; ORALPending4/2/2007 
AMINO ACID 15%

07P-0113/CP1
B BRAUN MEDICAL
INJECTIONApproved4/8/2009 
HYDROCODONE BITARTRATE 2.5 MG
HOMATROPINE METHYLBROMIDE 0.75 MG
07P-0134/CP1
LACHMAN CONSULTANT SERVICES
TABLETSPending4/12/2007 
HYDROCODONE BITARTRATE 2.5 MG PER 5 ML
HOMATROPINE METHYLBROMIDE 0.75 MG PER 5 ML
07P-0119/CP1
LACHMAN CONSULTANT SERVICES
SYRUPPending4/5/2007 
CLINDAMYCIN PHOSPHATE 1%

07P-0124/CP1
OLSSON, FRANK AND WEEDA
FOAM; NON-AEROSOLPending4/4/2007 
FLUDEOXYGLUCOSE F18 0.9-475 MCI/ML

07P-0126/CP1
PFI LLC
INJECTIONPending4/9/2007 
DEXAMETHASONE SODIUM PHOSPHATE 10 MG/ML
1 ML FILL SIZE
07P-0167/CP1
AKORN STRIDES
INJECTIONPending5/9/2007 
ACETAMINOPHEN 650 MG
BUTALBITAL 50 MG
07P-0194/CP1
LACHMAN CONSULTANT SERVICES
CAPSULESWithdrawn11/30/2011 
MEMANTINE HYDROCHLORIDE 5 MG, 10 MG

07P-0203/CP1
ORGENUS PHARMA
ORALLY DISINTEGRATING TABLETSApproved3/7/2011 
CEFAZOLIN 2 G VIALS

07P-0214/CP1
SANDOZ
INJECTIONPending6/5/2007 
DEFEROXAMINE MESYLATE 1 GRAM

07P-0216/CP1
BEN VENUE LABORATORIES
INJECTIONPending6/7/2007 
DONEPEZIL HYDROCHLORIDE 5 MG, 10 MG

07P-0226/CP1
LACHMAN CONSULTANT SERVICES
ORALLY DISSOLVING FILM STRIPSWithdrawn6/1/2009 
ESCITALOPRAM OXALATE 5 MG, 10 MG, 20 MG

07P-0239/CP1
LACHMAN CONSULTANT SERVICES
ORALLY DISSOLVING FILM STRIPSWithdrawn6/1/2009 
DIFLUNISAL USP 375 MG

07P-0247/CP1
LACHMAN CONSULTANT SERVICES
TABLETSApproved3/7/2011 
ACETAMINOPHEN 534.6 MG
CAFFEINE 45 MG
07P-0272/CP1
LACHMAN CONSULTANT SERVICES
TABLETSWithdrawn11/30/2011 
NABUMETONE 1000 MG

07P-0275/CP1
LACHMAN CONSULTANT SERVICES
TABLETSApproved3/18/2010 
FENOPROFEN CALCIUM 400 MG

07P-0293/CP1
EMCURE PHARMACEUTICALS
CAPSULESWithdrawn9/28/2009 
AMINO ACID 15 % 1 L GLASS BOTTLE

07P-0300/CP1
B. BRAUN MEDICAL
INJECTIONApproved4/8/2009 
HYDROCODONE BITARTRATE 5 MG
HOMATROPINE METHYLBROMIDE 1.5 MG
07P-0307/CP1
LACHMAN CONSULTANT SERVICES
CAPSULESPending8/10/2007 
RITONAVIR 100 MG

07P-0336/CP1
MATRIX LABORATORIES
TABLETSPending9/10/2007 
ZALEPLON 7.5 MG

07P-0398/CP1
LACHMAN CONSULTANT SERVICES
CAPSULESPending10/23/2007 
LEVOMETHADYL ACETATE HCL 10 MG, 20 MG, 40 MG

07P-0403/CP1
VCU SCHOOL OF MEDICINE
TABLETSPending10/23/2007 
CEFIXIME 100 MG/ML

07P-0404/CP1
LUPIN PHARMACEUTICALS
ORAL SUSPENSIONApproved9/1/2010 
ABACAVIR SULFATE 60 MG

07P-0407/CP1
MATRIX LABORATORIES
TABLETSPending10/31/2007 
DICLOFENAC SODIUM 50 MG, 75 MG
MISOPROSTOL 200 MCG
07P-0428/CP1
KING & SPALDING LLP
CAPSULESApproved9/1/2010 
LOPINAVIR 100 MG
RITONAVIR 25 MG
07P-0437/CP1
MATRIX LABORATORIES
TABLETSPending11/13/2007 
OXALIPLATIN 200 MG/VIAL

07P-0450/CP1
EBEWE PARENTA PHARMACEUTICALS
INJECTIONApproved9/1/2010 
LIDOCAINE 10 MG

08P-0001/CP1
ODAN LABORATORIES
ORAL SPRAY NON-AEROSOLPending1/7/2007 
FLUOROURACIL 1 GM/20 ML

08P-0003/CP1
EBEWE PARENTA
INJECTIONPending1/10/2007 
ATORVASTATIN CALCIUM 10 MG, 20 MG
40 MG, 80 MG
08P-0085/CP1
LUPIN PHARMACEUTICALS
CAPSULESApproved8/25/2010 
ESOMEPRAZOLE MAGNESIUM 20 MG, 40 MG

08P-0080/CP1
LUPIN PHARMACEUTICALS
TABLETS, DELAYED-RELEASEPending2/7/2008 
ACETAMINOPHEN 500 MG
CODEINE PHOSPHATE 15 MG, 30 MG, 60 MG
08P-0127/CP1
LACHMAN CONSULTANT SERVICES
TABLET, EFFERVESCENTWithdrawn3/23/2011 
HYDROCODONE BITARTRATE 2.5, 5, 7.5, 10 MG
ACETAMINOPHEN 500 MG
08P-0134/CP1
LACHMAN CONSULTANT SERVICES
TABLET; EFFERVESCENTWithdrawn3/23/2011 
BUTALBITAL 50 MG
ASPIRIN 500 MG
08P-0156/CP1
LACHMAN CONSULTANT SERVICES
CAPSULESApproved8/18/2010 
BUTALBITAL 50 MG
ASPIRIN 500 MG
08P-0155/CP1
LACHMAN CONSULTANT SERVICES
CAPSULESApproved8/18/2010 
CARBINOXAMINE MALEATE 6 MG

08P-0167/CP1
LACHMAN CONSULTANT SERVICES
TABLETSApproved3/7/2011 
CALCIUM ACETATE 667 MG/5 ML

08P-0175/CP1
BECKLOFF ASSOCIATES
ORAL SOLUTIONWithdrawn3/19/2008 
ALLOPURINOL 100 MG PER 5 ML

08P-0209/CP1
NEW ENGLAND BIOMEDICAL RESEARC
SUSPENSIONPending4/16/2008 
ESCITALOPRAM OXALATE 5 MG, 10 MG, 20 MG

08P-0216/CP1
LUPIN PHARMACEUTICALS
TABLETS, ORALLY DISINTEGRATINGPending4/16/2008 
VENLAFAXINE HYDROCHLORIDE 225 MG, 300 MG

08P-0247/CP1
KENDLE REGULATORY AFFAIRS
TABLET; EXTENDED-RELEASE; ORALWithdrawn11/21/2008 
ISONIAZID 100 MG, 300 MG

08P-0251/CP1
LACHMAN CONSULTANT SERVICES
TABLETS; ORAL SUSPENSIONPending5/5/2008 
CLOZAPINE 150 MG, 200 MG

08P-0294/CP1
LACHMAN CONSULTANT SERVICES
TABLETS; ORAL DISINTEGRATINGWithdrawn3/9/2011 
CLOZAPINE 150 MG

08P-0289/CP1
LACHMAN CONSULTANT SERVICES
TABLETSApproved3/7/2011 
GRISEOFULVIN ULTRAMICROSIZE 250 MG/5 ML

08P-0303/CP1
EMCURE PHARMACEUTICALS
SUSPENSION; ORALApproved12/29/2011 
BACLOFEN 5 MG

08P-0325/CP1
KENDLE REGULATORY AFFAIRS
TABLETSApproved3/18/2010 
TRAMADOL HYDROCHLORIDE 100 MG

08P-0327/CP1
KENDLE REGULATORY AFFAIRS
TABLETSApproved3/18/2010 
NIACIN 375 MG, 500 MG

08P-0340/CP1
LUPIN PHARMACEUTICALS
CAPSULE, EXTENDED RELEASEPending6/18/2008 
ALBUTEROL SULFATE 0.25%

08P-0344/CP1
NEPHRON PHARMACEUTICALS
SOLUTION; INHALATIONPending6/18/2008 
TOPOTECAN 1 MG/ML

08P-0348/CP1
OLSSON FRANK WEEDA
SOLUTION; INJECTABLEWithdrawn12/3/2009 
GEMCITABINE HCL 38 MG/ML

08P-0392/CP1
OLSSON FRANK & WEEDA
INJECTIONWithdrawn12/3/2009 
MORPHINE SULFATE 5 MG, 10 MG, 20 MG

08P-0401/CP1
RAKOCZY MOLINO MAZZOCHI SIWIK
TABLETSPending7/17/2008 
ZIDOVUDINE 100 MG

08P-0407/CP1
MATRIX LABORATORIES
TABLETSPending7/31/2008 
RIFAXIMIN 200 MG

08P-0404/CP1
STRIDES ARCOLAB
CAPSULESPending7/18/2008 
GLYCOPYRROLATE 1 MG/5 ML

08P-0414/CP1
LACHMAN CONSULTANT SERVICES
SOLUTIONWithdrawn3/9/2011 
PHYTONADIONE 2.5 MG,7.5 MG, 10 MG

08P-0421/CP1
LACHMAN CONSULTANT SERVICES
TABLETSApproved3/18/2010 
OLSALAZINE SODIUM 500 MG

08P-0422/CP1
LACHMAN CONSULTANT SERVICES
CAPSULESApproved3/18/2010 
AZACITIDINE 150 MG/VIAL

08P-0418/CP1
REGULUS PHARMACEUTICAL
INJECTIONPending7/28/2008 
HYDROCODONE BITARTRATE 2.5, 5, 7.5, 10 MG
ASPIRIN 325 MG
08P-0438/CP1
LACHMAN CONSULTANT SERVICES
TABLETSPending8/12/2008 
EFAVIRENZ 50 MG, 100 MG,200 MG

08P-0460/CP1
MATRIX LABORATORIES
TABLETSPending8/27/2008 
PENICILLAMINE 500 MG

08P-0463/CP1
LACHMAN CONSULTANT SERVICES
CAPSULESApproved3/18/2010 
CLONIDINE HYDROCHLORIDE 0.05 MG

08P-0489/CP1
LACHMAN CONSULTANT SERVICES
TABLETSDenied10/19/2010 
CEFEPIME 100 GRAM

08P-0539/CP1
SAMSOM MEDICAL TECHNOLOGIES
INJECTION USPApproved9/10/2010 
CEFIXIME 200 MG, 400 MG

08P-0534/CP1
LUPIN PHARMACEUTICALS
CAPSULESWithdrawn10/24/2011 
TOPOTECAN HYDROCHLORIDE 1 MG/1 ML; 3 MG/3 ML
4 MG/4 ML
08P-0591/CP1
REGULUS PHARMACEUTICAL
SOLUTIONApproved7/30/2012 
PREDNISOLONE SODIUM PHOSPHATE 30 MG/5ML

08P-0584/CP1
COHEN TAUBER SPIEVACK & WAGNER
SOLUTIONApproved5/6/2011 
OXYCODONE HYDROCHLORIDE 5 MG

08P-0598/CP1
VINTAGE PHARMACEUTICALS
CAPSULESWithdrawn5/7/2012 
SULINDAC 200 MG

08P-0647/CP1
LACHMAN CONSULTANT SERVICES
CAPSULESWithdrawn3/9/2011 
MINOXIDIL 2%, 5% W/W

08P-0643/CP1
BAKER & HOSTETLER
CREAM; TOPICALPending12/18/2008 
CARBOPLATIN 1000 MG/100 ML

08P-0660/CP1
ONCOTHERAPIES
INJECTIONPending1/5/2009 
RIFAMPIN 50 MG/5 ML
100 MG/5 ML
08P-0662/CP1
LACHMAN CONSULTANT SERVICES
SUSPENSION; ORALPending1/5/2009 
CLOZAPINE 50 MG/ML

09P-0046/CP1
LACHMAN CONSULTANT SERVICES
ORAL SUSPENSIONWithdrawn5/7/2012 
SODIUM ACETATE 32.8% PBP

09P-0055/0001
APP PHARMACEUTICALS
INJECTIONApproved10/6/2010 
POTASSIUM ACETATE 100 ML/100 CC PBP

09P-0068/CP1
APP PHARMACEUTICALS
INJECTIONApproved6/22/2011 
BACTERIOSTATIC WATER 20 ML/30 CC VIAL

09P-0067/CP1
APP PHARMACEUTICALS
INJECTIONApproved6/22/2011 
SODIUM ACETATE 16.4% PBP

09P-0055/0003
APP PHARMACEUTICALS
INJECTIONApproved9/7/2010 
SODIUM CHLORIDE 100 ML/100 CC PBP
200 ML/200 CC PBP
09P-0069/CP1
APP PHARMACEUTICALS
INJECTIONPending2/19/2009 
GEMCITABINE HYDROCHLORIDE 38 MG/ML

09P-0076/CP1
PHARMAFORCE
INJECTIONPending2/19/2009 
STERILE WATER 5 ML/6 CC VIAL
100 ML/100 CC VIAL
09P-0070/CP1
APP PHARMACEUTICALS
INJECTIONApproved9/7/2010 
TOPOTECAN HYDROCHLORIDE 1 MG/ML

09P-0077/CP1
PHARMAFORCE
INJECTIONPending2/19/2009 
SODIUM CHLORIDE 100 ML

09P-0104/CP1
APP PHARMACEUTICALS
INJECTIONWithdrawn3/10/2011 
POTASSIUM PHOSPHATES 5 ML/10 CC
15 ML/30 CC
09P-0082/CP1
APP PHARMACEUTICALS
INJECTIONWithdrawn3/10/2009 
MAGNESIUM SULFATE 20 ML AND 50 ML

09P-0091/CP1
APP PHARMACEUTICALS
INJECTIONWithdrawn2/26/2009 
POTASSIUM ACETATE 50 ML

09P-0102/CP1
APP PHARMACEUTICALS
INJECTIONPending2/26/2009 
SODIUM BICARBONATE 5 ML

09P-0085/CP1
APP PHARMACEUTICALS
INJECTIONApproved3/30/2011 
SODIUM PHOSPHATES 5 ML/10 CC
50 ML/50 CC
09P-0080/CP1
APP PHARMACEUTICALS
INJECTIONApproved3/30/2011 
SODIUM ACETATE 50 ML SDV

09P-0107/CP1
APP PHARMACEUTICALS
INJECTIONPending3/3/2009 
POTASSIUM ACETATE 50 ML

09P-0108/CP1
APP PHARMACEUTICALS
INJECTIONApproved6/22/2011 
SODIUM ACETATE 50 ML SDV

09P-0109/CP1
APP PHARMACEUTICALS
INJECTIONApproved6/22/2011 
METRONIDAZOLE 50 MG

09P-0121/CP1
PHARMENG TECHNOLOGY INC.
TABLETSPending3/4/2009 
CYCLOBENZAPRINE HYDROCHLORIDE 15 MG, 30 MG

09P-0168
FOLEY & LARDNER
TABLET; EXTENDED-RELEASE; ORALPending4/8/2009 
PREDNISOLONE 10 MG, 15 MG, 30 MG

09P-0180/CP1
LACHMAN CONSULTANT SERVICES
TABLETSApproved10/6/2010 
PYRIDOXINE HYDROCHLORIDE 100 MG/ML, 10 ML FIL

09P-0185
BIONICHE PHARMA
INJECTIONApproved10/6/2010 
BENZONATATE 125 MG, 175 MG

09P-0190
LACHMAN CONSULTANT SERVICES
CAPSULESDenied10/8/2013 
OXYCODONE HYDROCHLORIDE 2.5, 5, 7.5, 10 MG
ACETAMINOPHEN 500 MG
09P-0203-0001
LACHMAN CONSULTANT SERVICES
TABLETS; EFFERVESCENTWithdrawn3/23/2011 
OXYCODONE HYDROCHLORIDE 2.5, 5, 7.5 10 MG
ACETAMINOPHEN 650 MG
09P-0203-0003
LACHMAN CONSULTANT SERVICES
TABLETS; EFFERVESCENTWithdrawn3/23/2011 
GANCICLOVIR SODIUM 50 MG/ML

09P-0222/CP1
PHARMAFORCE
INJECTIONApproved11/16/2010 
FLURANDRENOLIDE 0.004 MG/SQ

09P-0229/CP1
SCARGUARD LABS
TOPICAL LIQUIDPending5/27/2009 
PROMETHAZINE HYDROCHLORIDE 25 MG, 50 MG

09P-0249/CP
LACHMAN CONSULTANT SERVICES
TABLETS; EFFERVESCENTWithdrawn4/7/2011 
ZOLPIDEM TARTRATE 5 MG, 10 MG

09P-0248/CP
LACHMAN CONSULTANT SERVICES
TABLET; EFFERVESCENTPending6/1/2009 
PENTETATE ZINC TRISODIUM 1055 MG/5 ML

09P-0258/CP
HEYL CHEMISCH
INJECTION; SOLUTIONPending6/9/2009 
LEVETIRACETAM 1000 MG, 1500 MG

09P-0285/CP
THE WEINBERG GROUP
TABLET; EXTENDED-RELEASE; ORALApproved9/7/2010 
CHLORPHENIRAMINE MALEATE 8 MG
PSEUDOEPHEDRINE HYDROCHLORIDE 120 MG
09P-0320/CP
PHARMA MEDICA
TABLET; EXTENDED-RELEASE; ORALPending7/27/2009 
DACTINOMYCIN 0.5 MG/ML

09P-0367
PHARMAFORCE
INJECTIONPending8/12/2009 
MORPHINE SULFATE 20 MG/ML

09P-0388
MERCHANT & GOULD
SOLUTION (CONCENTRATE)Withdrawn12/2/2013 
MAGNESIUM SULFATE 50% 20 ML, 50 ML FIL

09P-0397
OLSSON FRANK WEEDA
INJECTIONApproved9/7/2010 
SODIUM BICARBONATE 8.4% 1 MEQ/ML 10 ML
4.2% 0.5 MEQ/ML 5 ML
09P-0396
OLSSON FRANK WEEDA
INJECTIONApproved10/6/2010 
OXYCODONE HYDROCHLORIDE 2.5 MG

09P-0399
REGULUS PHARMACEUTICAL CONSULT
TABLETSApproved11/16/2010 
MULTIVITAMIN SINGLE DOSE
PHARMACY BULK PKG
09P-0417
STRIDES
FOR INJECTIONWithdrawn11/15/2010 
TRAMADOL HYDROCHLORIDE 75 MG
ACETAMINOPHEN 650 MG
09P-0429
LACHMAN CONSULTANT SERVICES
TABLETSWithdrawn11/30/2011 
BUPRENORPHINE HYDROCHLORIDE 8 MG
NALOXONE HYDROCHLORIDE 2 MG
09P-0459
AERSCHER LLC
ORAL STRIPPending9/29/2009 
PRIMIDONE 50, 100, 125, 250 MG

09P-0477
LACHMAN CONSULTANT SERVICES
CAPSULESApproved1/16/2013 
PRIMIDONE 25 MG,100 MG, 125 MG

09P-0482
LACHMAN CONSULTANT SERVICES
TABLETSApproved11/15/2012 
CHLORPHENIRAMINE MALEATE 8 MG
PSEUDOEPHEDRINE HYDROCHLORIDE 120 MG
09P-0478
THE WEINBERG GROUP
CAPSULE, EXTENDED RELEASE; ORALPending10/13/2009 
PRIMIDONE 50, 100, 125, 250 MG

09P-0481
LACHMAN CONSULTANT SERVICES
TABLETS ORALLY DISINTEGRATINGApproved1/16/2013 
SODIUM CHLORIDE 0.9% 9 MG/ML

09P-0565
BAXTER HEALTHCARE
INJECTIONApproved5/6/2011 
ACETAMINOPHEN 500 MG

10P-0011
BRIGHT FUTURE PHARMACEUTICALS
TABLETSWithdrawn1/25/2010 
MORPHINE SULFATE 25 MG/ML
50 ML & 100 ML VIALS
10P-0012
ALAUNUS PHARMACEUTICAL LLC
INJECTIONWithdrawn12/29/2011 
ZOLPIDEM TARTRATE 7.5 MG

10P-0015
LACHMAN CONSULTANT SERVICES
TABLETSDenied10/8/2013 
DOCETAXEL 20 MG, 80 MG, 200 MG

10P-0086
HYMAN, PHELPS & MCNAMARA
INJECTION; POWDER FOR SOLUTIONDenied1/19/2011 
GEMCITABINE HYDROCHLORIDE 10 MG/ML

10P-0096
ONCOTHERAPIES LIMITED
INJECTIONPending2/24/2010 
OXYTOCIN 1000 USP UNITS/100ML

10P-0112
ALAUNUS PHARMACEUTICAL LLC
INJECTIONPending3/2/2010 
PYRIDOXINE HYDROCHLORIDE 3 G/30 ML

10P-0114
MCGUFF PHARMACEUTICALS
INJECTIONApproved11/15/2012 
DOCETAXEL 20 MG/ML

10P-0130
ONCOTHERAPIES
INJECTIONWithdrawn5/7/2012 
IBUPROFEN 100 MG/5 ML

10P-0145
ACTAVIS
SUSPENSION; ORALPending4/8/2010 
FENTANYL CITRATE 500 ML VIAL

10P-0222
PATRICK FOSTER
INJECTION SOLUTIONWithdrawn5/7/2012 
FEXOFENADINE HCL 15 MG

10P-0232
HYMAN, PHELPS & MCNAMARA
ORALLY DISINTEGRATING TABLETWithdrawn3/1/2011 
FEXOFENADINE HCL 15 MG/5 ML

10P-0231
HYMAN, PHELPS & MCNAMARA
SUSPENSION; ORALApproved1/28/2013 
FEXOFENADINE HCL 120 MG

10P-0230
HYMAN, PHELPS & MCNAMARA
TABLETSWithdrawn5/10/2010 
DRONABINOL 0.25 MG, 0.5 MG,
1.0 MG
10P-0353
K & L GATES
NASAL SPRAYPending7/7/2010 
IMATINIB MESYLATE 50 MG, 200 MG,
600 MG
10P-0341
HYMAN, PHELPS & MCNAMARA
TABLETSApproved11/15/2012 
IMATINIB MESYLATE 100 MG, 400 MG,

10P-0360
HYMAN, PHELPS & MCNAMARA
CAPSULESApproved1/22/2014 
LACTULOSE CRYSTALS

10P-0398
BENNETT AND COMPANY
LIQUID; ORALWithdrawn1/6/2012 
FENTANYL CITRATE 50 MCG/1 ML

10P-0413
OLSSON FRANK WEEDA
INJECTIONApproved1/28/2013 
FLUDEOXYGLUCOSE F 18 500 MCI/ML

10P-0444
MAYO CLINIC
INJECTIONApproved5/20/2011 
MIDAZOLAM HYDROCHLORIDE 500 MG/100 ML

10P-0460
ALAUNUS
INJECTIONApproved7/7/2012 
DULOXETINE HYDROCHLORIDE 40 MG

10P-0535
HYMAN, PHELPS & MCNAMARA
CAPSULE, DELAYED RELEASEApproved4/18/2012 
METFORMIN HYDROCHLORIDE 500 MG, 850 MG
1 GM
10P-0533
ZYDUS PHARMACEUTICALS
POWDER FOR SOLUTIONApproved9/27/2012 
MERCAPTOPURINE 25 MG

10P-0582
LACHMAN CONSULTANT SERVICES
TABLETApproved3/27/2012 
DOCETAXEL 200 MG

10P-0639
MIKE BERNSTEIN
INJECTIONApproved3/27/2012 
PIPERACILLIN SODIUM 300 & 360 GRAMS
TAZOBACTAM SODIUM 37.5 & 45 GRAMS
11P-0031
SAMSON MEDICAL
INJECTIONPending1/14/2011 
PEMETREXED 1000 MG

11P-0052
LACHMAN CONSULTANT SERVICES
INJECTIONApproved3/27/2012 
ACETAMINOPHEN 325 MG
BUTALBITAL 25 MG
11P-0093
SOVEREIGN PHARMACEUTICALS
TABLETSApproved4/18/2012 
ACETAMINOPHEN 325 MG
CAFFEINE 30 MG
11P-0096
SOVEREIGN PHARMACEUTICALS
TABLETSApproved9/27/2012 
BUTALBITAL 50 MG
ACETAMINOPHEN 300 MG
11P-0106
LACHMAN CONSULTANT SERVICES
CAPSULESWithdrawn3/28/2011 
CALCIUM ACETATE 667 MG/5 ML

11P-0115
CYPRESS PHARMACEUTICAL
ORAL SOLUTIONWithdrawn5/7/2012 
ONDANSETRON 4 MG, 8 MG

11P-0166
LACHMAN CONSULTANT SERVICES
EFFERVESCENT TABLETSDenied6/19/2012 
BUTALBITAL 50 MG
ACETAMINOPHEN 300 MG
11P-0167
LACHMAN CONSULTANT SERVICES
CAPSULESApproved7/7/2012 
LEVETIRACETAM 1000 MG/VIAL

11P-0186
NEXUS PHARMACEUTICALS
INJECTIONPending3/29/2011 
HYDROCODONE BITARTRATE 2.5, 5, 7.5, 10 MG
ACETAMINOPHEN 325 MG
11P-0302
LACHMAN CONSULTANT SERVICES
EFFERVESCENT TABLETSDenied7/30/2012 
AMMONIA N 13 3.75 - 260 mCi/mL

11P-0337
PRECISION NUCLEAR, LLC
INJECTIONApproved9/1/2011 
MINOCYCLINE HYDROCHLORIDE 70 MG, 95 MG

11P-0347
LACHMAN CONSULTANT SERVICES
TABLET; EXTENDED-RELEASE; ORALApproved1/28/2013 
DEXMEDETOMIDINE HYDROCHLORIDE 400 MCG/4 ML
1000 MCG/10 ML
11P-0381
LACHMAN CONSULTANT SERVICES
SOLUTION (CONCENTRATE)Withdrawn10/6/2011 
PENTAZOCINE HYDROCHLORIDE 12.5 MG, 25 MG
ACETAMINOPHEN 325 MG
11P-0459
LACHMAN CONSULTANT SERVICES
TABLETSApproved12/19/2013 
LACTATED RINGERS 3000 ML

11P-0550
B. BRAUN MEDICAL
INJECTIONWithdrawn8/16/2012 
STERILE WATER 2000 ML, 3000 ML

11P-0551
B. BRAUN MEDICAL
INJECTIONWithdrawn8/16/2012 
METFORMIN HYDROCHLORIDE 500 MG, 850 MG, 1 G

11P-0558
LACHMAN CONSULTANT SERVICES
CHEWABLE TABLETSApproved9/27/2012 
ACETAMINOPHEN 320.5 MG
CAFFEINE 30 MG
11P-0728
WRASER PHARMACEUTICALS
CAPSULESApproved7/7/2012 
ALLOPURINOL 100 MG/5 ML

11P-0740
ALLAN M. GREEN, M.D.
LIQUID SUSPENSIONPending10/24/2011 
WATER FOR INJECTION USP 0.5, 1.0, 1.5, 2.0,
2.5, 4.0, 6.0, 7.0,
11P-0818
JUBILANT HOLLISTERSTIER
INJECTIONPending1/10/2012 
SODIUM CHLORIDE 0.9%

11P-0846
JUBILANT HOLLISTERSTIER
INJECTIONPending1/10/2012 
LEVOLEUCOVORIN CALCIUM 50 MG/5 ML

11P-0821
LACHMAN CONSULTANT SERVICES
INJECTIONPending11/17/2011 
KALEXATE 15 GM/BOTTLE

11P-0913
KVK-TECH, INC.
POWDERApproved1/28/2013 
TRIAMTERENE 50 MG
HYDROCHLOROTHIAZIDE 25 MG
12P-0061
LANNETT COMPANY
CAPSULESWithdrawn2/10/2012 
SODIUM FLUORIDE F 18 20-600 mCi/mL

12P-0103
FEINSTEIN INSTITUTE
INJECTIONApproved2/29/2012 
DOXORUBICIN HYDROCHLORIDE 100 MG/50 ML

12P-0200
PHARMAFORCE
INJECTIONApproved1/23/2013 
BORTEZOMIB 1 MG, 2.5 MG

12P-0272
ACTAVIS
INJECTIONPending3/23/2012 
FLUDEOXYGLUCOSE F18 1-20 mCi/mL EOS

12P-0387
ABT MOLECULAR IMAGING
INJECTIONApproved6/7/2012 
ACETAMINOPHEN 312.5 MG
PENTAZOCINE HCL 25 MG
12P-0478
XSPIRE PHARMA
TABLETSPending5/24/2012 
IMATINIB 400 MG/5 ML

12P-0479
NATCO PHARMA LIMITED
ORAL SOLUTIONPending5/24/2012 
LACTULOSE 10 GRAMS & 20 GRAMS

12P-0496
CUMBERLAND PHARMACEUTICALS
POWDER FOR ORAL SOLUTIONWithdrawn4/9/2013 
DOCETAXEL 160 MG/8 ML

12P-0589
ONCO THERAPIES LIMITED
INJECTIONPending6/19/2012 
COLCHICINE 0.3 MG, 1.2 MG,
1.8 MG
12P-0632
PAR PHARMACEUTICALS
TABLETSPending6/19/2012 
METOPROLOL SUCCINATE 12.5 MG

12P-0698
LACHMAN CONSULTANT SERVICES
TABLET; EXTENDED-RELEASE; ORALPending7/5/2012 
ACETAMINOPHEN 312.5 mg
CAFFEINE 60 mg
12P-0775
XSPIRE PHARMA
TABLETPending7/26/2012 
SITAGLIPTIN 50 MG
METFORMIN HYDROCHLORIDE 850 MG
12P-0826
LACHMAN CONSULTANT SERVICES
TABLET; EXTENDED-RELEASE; ORALPending8/2/2012 
TADALAFIL 40 MG

12P-0935
LACHMAN CONSULTANT SERVICES
TABLETSPending8/31/2012 
HYDROCODONE BITARTRATE 2.5, 3.75, 5 MG
ACETAMINOPHEN 250 MG, 325 MG
12P-0964
LANNETT COMPANY
TABLETSWithdrawn12/6/2012 
SODIUM ACETATE 4 MEQ/ML

12P-0982
SHEPPARD MULLIN
INJECTIONWithdrawn11/9/2012 
POTASSIUM ACETATE 200 MEQ

12P-0983
SHEPPARD MULLIN
INJECTIONWithdrawn11/9/2012 
ATROPINE SULFATE 1.0 MG/ML

12P-0986
SHEPPARD MULLIN
INJECTIONPending9/21/2012 
MAGNESIUM SULFATE 50 ML

12P-1004
SHEPPARD MULLIN
INJECTIONWithdrawn11/9/2012 
VALRUBICIN 800 MG/20 ML

12P-1029
LACHMAN CONSULTANT SERVICES
SOLUTIONPending10/23/2012 
MEFENAMIC ACID 500 MG

12P-1058
LACHMAN CONSULTANT SERVICES
CAPSULESPending10/23/2012 
ONDANSETRON 16 MG/25 ML

12P-1068
BEN VENUE
INJECTIONWithdrawn2/15/2013 
FASPROFEN 100 MG

12P-1112
NOBEL LABORATORIES, LLC
ORALLY DISINTEGRATING TABLETPending11/14/2012 
DEXMEDETOMIDINE HYDROCHLORIDE 400 MCG/4 ML VIAL

12P-1147
FOLEY & LARDNER LLP
INJECTIONPending11/20/2012 
OXYCODONE HYDROCHLORIDE 10,15, 20, 30 MG
40, 60, 80 MG
12P-1180
LANNETT
CAPSULE, EXTENDED RELEASE; ORALPending12/18/2012 
MORPHINE SULFATE 5 MG/ML

12P-1251
GORDON JOHNSTON REGULATORY CON
INJECTIONPending1/8/2013 
PEMETREXED DISODIUM 750 MG/VIAL

12P-1259
HYMAN PHELPS & MCNAMARA
INJECTIONPending1/8/2013 
ASPIRIN 325 MG
HYDROCODONE BITARTRATE 5 MG
12P-1267
XSPIRE PHARMA
TABLET; ORALPending1/8/2013 
HYDROXYCHLOROQUINE SULFATE 100, 300, 400 MG

13P-0170
CLINIPACE
TABLETPending2/19/2013 
SODIUM IODIDE I 131 500 - 3500 MCI/ML

13P-0219
INTERNATIONAL ISOTOPES
SOLUTION (CONCENTRATE)Pending3/1/2013 
MINOCYCLINE HYDROCHLORIDE 70 MG, 95 MG

11P-0347/PRC
MEDICIS
TABLET; EXTENDED-RELEASE; ORALPending3/26/2013 
POTASSIUM CITRATE 10, 20, 25 MEQ

13P-0506
NOMAX, INC.
TABLET; EFFERVESCENTPending5/16/2013 
PIROXICAM 5 MG

13P-0666
URL PHARMA
CAPSULESWithdrawn6/25/2013 
TRAMADOL HYDROCHLORIDE 37.5 MG
ACETAMINOPHEN 300 MG
13P-0675
LACHMAN CONSULTANT SERVICES
TABLETSPending6/14/2013 
TACROLIMUS 0.5 MG/ML

13P-0767
ASCEND LABORATORIES
ORAL SUSPENSIONPending7/5/2013 
BENDAMUSTINE HYDROCHLORIDE 200 MG/VIAL

13P-0769
LACHMAN CONSULTANT SERVICES
INJECTIONPending7/15/2013 
DAPSONE 50 MG

13P-0800
LACHMAN CONSULTANT SERVICES
TABLETSPending7/15/2013 
GRISEOFULVIN 187.5 MG AND 375 MG

13P-0799
LACHMAN CONSULTANT SERVICES
TABLETSPending7/15/2013 
HYDROCODONE BITARTRATE 4 MG, 6 MG, 8 MG
ACETAMINOPHEN 300 MG
13P-0813
LACHMAN CONSULTANT SERVICES
TABLETSPending7/15/2013 
HYDROMORPHONE HCL 24 MG

13P-0830
LACHMAN CONSULTANT SERVICES
TABLET; EXTENDED-RELEASE; ORALPending7/16/2013 
TIZANIDINE HYDROCHLORIDE 8 MG

13P-0847
LACHMAN CONSULTANT SERVICES
TABLETSPending7/25/2013 
IMATINIB MESYLATE 300 MG

13P-1002
ZYDUS PHARMACEUTICALS
TABLETSPending10/7/2013 
GANCICLOVIR 500 MG/10 ML

13P-1061
NAVINTA LLC
SOLUTIONPending10/7/2013 
VANCOMYCIN HYDROCHLORIDE 1.5 GRAMS VIAL

13P-1202
OLSSON FRANK WEEDA
INJECTIONPending10/7/2013 
HYDROMORPHONE HYDROCHLORIDE 1 MG/5 ML

14P-0076
LANNETT
ORAL SOLUTIONPending2/6/2014 
HYDROMORPHONE HYDROCHLORIDE 1 MG

14P-0196
LANNETT
TABLETPending2/12/2014 
LEUCOVORIN CALCIUM 50 MG/5 ML
200 MG/20 ML
14P-0251
GORDON JOHNSTON REGULATORY
INJECTIONPending3/6/2014 
CISPLATIN 10 MG/10 ML
25 MG/25 ML
14P-0284
LACHMAN CONSULTANT SERVICES
INJECTIONPending3/11/2014 

 

 
 

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