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Drugs@FDA: FDA-Approved Drugs

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All Approvals and Tentative Approvals
February 1993

This report includes approvals of NDAs, BLAs, ANDAs, and approved supplements to those applications, and tentative ANDA/NDA approvals during the selected month. This report does not include BLAs/NDAs and supplements to those applications approved by CBER.

Click on the Drug Name and Application Number to see information about the drug (for example, regulatory history, labeling, reviews by FDA staff).

This report was produced on May 02, 2024.

Approval Date Drug Name Submission Active Ingredients Company Submission Classification * Submission Status
02/01/1993 COUMADIN
NDA #009218		 SUPPL-72 WARFARIN SODIUM BRISTOL MYERS SQUIBB Labeling Approval
02/01/1993 DOBUTREX
NDA #017820		 SUPPL-25 DOBUTAMINE HYDROCHLORIDE LILLY Manufacturing (CMC) Approval
02/01/1993 SUDAFED 24 HOUR
NDA #020021		 SUPPL-1 PSEUDOEPHEDRINE HYDROCHLORIDE J AND J CONSUMER INC Manufacturing (CMC) Approval
02/01/1993 DIAZEPAM
ANDA #070311		 SUPPL-8 DIAZEPAM HIKMA Labeling Approval
02/01/1993 ALBUTEROL SULFATE
ANDA #072629		 SUPPL-2 ALBUTEROL SULFATE WATSON LABS Labeling Approval
02/01/1993 ALBUTEROL SULFATE
ANDA #072630		 SUPPL-2 ALBUTEROL SULFATE WATSON LABS Labeling Approval
02/01/1993 NICOLAR
ANDA #083823		 SUPPL-9 NIACIN SANOFI AVENTIS US Labeling Approval
02/01/1993 MINITRAN
ANDA #089771		 SUPPL-14 NITROGLYCERIN VALEANT PHARMS Manufacturing (CMC) Approval
02/01/1993 MINITRAN
ANDA #089772		 SUPPL-13 NITROGLYCERIN VALEANT PHARMS NORTH Manufacturing (CMC) Approval
02/01/1993 MINITRAN
ANDA #089773		 SUPPL-13 NITROGLYCERIN BAUSCH Manufacturing (CMC) Approval
02/01/1993 MINITRAN
ANDA #089774		 SUPPL-14 NITROGLYCERIN VALEANT PHARMS Manufacturing (CMC) Approval
02/02/1993 AQUASOL A
NDA #006823		 SUPPL-13 VITAMIN A PALMITATE CASPER PHARMA LLC Manufacturing (CMC) Approval
02/02/1993 M.V.I.-12 ADULT
NDA #008809		 SUPPL-27 ASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; DEXPANTHENOL; ERGOCALCIFEROL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN 5'-PHOSPHATE SODIUM; THIAMINE HYDROCHLORIDE; VITAMIN A; VITAMIN E HOSPIRA Manufacturing (CMC) Approval
02/02/1993 M.V.I.-12 ADULT
NDA #008809		 SUPPL-27 ASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; DEXPANTHENOL; ERGOCALCIFEROL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; THIAMINE HYDROCHLORIDE; VITAMIN A; VITAMIN E HOSPIRA Manufacturing (CMC) Approval
02/02/1993 CHRONULAC
NDA #017884		 SUPPL-22 LACTULOSE SANOFI AVENTIS US Manufacturing (CMC) Approval
02/02/1993 RESTORIL
NDA #018163		 SUPPL-44 TEMAZEPAM SPECGX LLC Labeling Approval
02/02/1993 ZOLADEX
NDA #019726		 SUPPL-5 GOSERELIN ACETATE TERSERA Efficacy Approval
02/02/1993 PROSTEP
NDA #019983		 SUPPL-5 NICOTINE AVEVA Manufacturing (CMC) Approval
02/02/1993 PROSTEP
NDA #019983		 SUPPL-6 NICOTINE AVEVA Manufacturing (CMC) Approval
02/02/1993 ZOFRAN
NDA #020007		 SUPPL-1 ONDANSETRON HYDROCHLORIDE SANDOZ Labeling Approval
02/02/1993 ZOFRAN
NDA #020007		 SUPPL-2 ONDANSETRON HYDROCHLORIDE SANDOZ Labeling Approval
02/02/1993 ZOFRAN
NDA #020007		 SUPPL-3 ONDANSETRON HYDROCHLORIDE SANDOZ Efficacy Approval
02/02/1993 ZOFRAN
NDA #020007		 SUPPL-4 ONDANSETRON HYDROCHLORIDE SANDOZ Labeling Approval
02/02/1993 ZOFRAN
NDA #020007		 SUPPL-7 ONDANSETRON HYDROCHLORIDE SANDOZ Labeling Approval
02/02/1993 ZOFRAN
NDA #020007		 SUPPL-8 ONDANSETRON HYDROCHLORIDE SANDOZ Labeling Approval
02/02/1993 ZOFRAN PRESERVATIVE FREE
NDA #020007		 SUPPL-1 ONDANSETRON HYDROCHLORIDE SANDOZ Labeling Approval
02/02/1993 ZOFRAN PRESERVATIVE FREE
NDA #020007		 SUPPL-2 ONDANSETRON HYDROCHLORIDE SANDOZ Labeling Approval
02/02/1993 ZOFRAN PRESERVATIVE FREE
NDA #020007		 SUPPL-3 ONDANSETRON HYDROCHLORIDE SANDOZ Efficacy Approval
02/02/1993 ZOFRAN PRESERVATIVE FREE
NDA #020007		 SUPPL-4 ONDANSETRON HYDROCHLORIDE SANDOZ Labeling Approval
02/02/1993 ZOFRAN PRESERVATIVE FREE
NDA #020007		 SUPPL-7 ONDANSETRON HYDROCHLORIDE SANDOZ Labeling Approval
02/02/1993 ZOFRAN PRESERVATIVE FREE
NDA #020007		 SUPPL-8 ONDANSETRON HYDROCHLORIDE SANDOZ Labeling Approval
02/02/1993 GENTAMICIN SULFATE
ANDA #062531		 SUPPL-4 GENTAMICIN SULFATE FOUGERA PHARMS INC Labeling Approval
02/02/1993 IMIPRAMINE HYDROCHLORIDE
ANDA #087846		 SUPPL-10 IMIPRAMINE HYDROCHLORIDE SPECGX LLC Labeling Approval
02/02/1993 TOFRANIL
ANDA #087846		 SUPPL-10 IMIPRAMINE HYDROCHLORIDE SPECGX LLC Labeling Approval
02/02/1993 SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
ANDA #088912		 SUPPL-20 SODIUM CHLORIDE FRESENIUS KABI USA Labeling Approval
02/03/1993 M.V.I.-12 ADULT
NDA #008809		 SUPPL-28 ASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; DEXPANTHENOL; ERGOCALCIFEROL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN 5'-PHOSPHATE SODIUM; THIAMINE HYDROCHLORIDE; VITAMIN A; VITAMIN E HOSPIRA Manufacturing (CMC) Approval
02/03/1993 M.V.I.-12 ADULT
NDA #008809		 SUPPL-28 ASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; DEXPANTHENOL; ERGOCALCIFEROL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; THIAMINE HYDROCHLORIDE; VITAMIN A; VITAMIN E HOSPIRA Manufacturing (CMC) Approval
02/03/1993 FUROSEMIDE
NDA #018413		 SUPPL-21 FUROSEMIDE CHARTWELL RX Manufacturing (CMC) Approval
02/03/1993 PRIMAXIN
ANDA #062756		 SUPPL-14 CILASTATIN SODIUM; IMIPENEM MERCK Labeling Approval
02/03/1993 IBUPROFEN
ANDA #073343		 SUPPL-1 IBUPROFEN TEVA Manufacturing (CMC) Approval
02/03/1993 IBUPROFEN
ANDA #073344		 SUPPL-1 IBUPROFEN TEVA Manufacturing (CMC) Approval
02/03/1993 IBUPROFEN
ANDA #073345		 SUPPL-1 IBUPROFEN TEVA Manufacturing (CMC) Approval
02/03/1993 MICONAZOLE NITRATE
ANDA #074030		 SUPPL-2 MICONAZOLE NITRATE TEVA PHARMS Labeling Approval
02/03/1993 POTASSIUM CHLORIDE
ANDA #083163		 SUPPL-17 POTASSIUM CHLORIDE INTL MEDICATION Manufacturing (CMC) Approval
02/03/1993 MAXIDEX
ANDA #083342		 SUPPL-11 DEXAMETHASONE SODIUM PHOSPHATE ALCON Manufacturing (CMC) Approval
02/03/1993 NEMBUTAL SODIUM
ANDA #084093		 SUPPL-9 PENTOBARBITAL SODIUM EPIC PHARMA LLC Manufacturing (CMC) Approval
02/04/1993 VIDEX
NDA #020154		 SUPPL-4 DIDANOSINE BRISTOL MYERS SQUIBB Manufacturing (CMC) Approval
02/04/1993 ATENOLOL
ANDA #073542		 SUPPL-3 ATENOLOL STRIDES PHARMA Labeling Approval
02/04/1993 ATENOLOL
ANDA #073543		 SUPPL-3 ATENOLOL STRIDES PHARMA Labeling Approval
02/04/1993 ATENOLOL
ANDA #074099		 SUPPL-2 ATENOLOL STRIDES PHARMA Labeling Approval
02/04/1993 ACETAMINOPHEN AND CODEINE PHOSPHATE
ANDA #088629		 SUPPL-18 ACETAMINOPHEN; CODEINE PHOSPHATE NOSTRUM LABS INC Labeling Approval
02/05/1993 VIRAZOLE
NDA #018859		 SUPPL-3 RIBAVIRIN BAUSCH Efficacy Approval
02/05/1993 NOVAMINE 15% SULFITE FREE IN PLASTIC CONTAINER
NDA #020107		 ORIG-1 AMINO ACIDS BAXTER HLTHCARE Type 5 - New Formulation or New Manufacturer Approval
02/05/1993 SUPRAX
NDA #050621		 SUPPL-10 CEFIXIME LEDERLE Efficacy Approval
02/05/1993 AMOXAPINE
ANDA #072691		 SUPPL-1 AMOXAPINE WATSON LABS Labeling Approval
02/08/1993 CARDIZEM
NDA #018602		 SUPPL-42 DILTIAZEM HYDROCHLORIDE BAUSCH Manufacturing (CMC) Approval
02/08/1993 DYNACIRC
NDA #019546		 SUPPL-10 ISRADIPINE SMITHKLINE BEECHAM Manufacturing (CMC) Approval
02/08/1993 ROCEPHIN
NDA #050585		 SUPPL-41 CEFTRIAXONE SODIUM HOFFMANN LA ROCHE Manufacturing (CMC) Approval
02/08/1993 ROCEPHIN KIT
NDA #050585		 SUPPL-41 CEFTRIAXONE SODIUM; LIDOCAINE HOFFMANN LA ROCHE Manufacturing (CMC) Approval
02/08/1993 CEFADROXIL
ANDA #062766		 SUPPL-6 CEFADROXIL/CEFADROXIL HEMIHYDRATE IVAX SUB TEVA PHARMS Manufacturing (CMC) Approval
02/08/1993 CEFAZOLIN SODIUM
ANDA #062989		 SUPPL-5 CEFAZOLIN SODIUM DR REDDYS Manufacturing (CMC) Approval
02/08/1993 ENULOSE
ANDA #071548		 SUPPL-16 LACTULOSE ACTAVIS MID ATLANTIC Manufacturing (CMC) Approval
02/08/1993 ATENOLOL
ANDA #073457		 SUPPL-4 ATENOLOL MYLAN Labeling Approval
02/08/1993 LIDOCAINE HYDROCHLORIDE
ANDA #083173		 SUPPL-24 LIDOCAINE HYDROCHLORIDE INTL MEDICATION Manufacturing (CMC) Approval
02/08/1993 LIDOCAINE HYDROCHLORIDE
ANDA #086283		 SUPPL-11 LIDOCAINE HYDROCHLORIDE INTL MEDICATION Manufacturing (CMC) Approval
02/08/1993 LIDOCAINE HYDROCHLORIDE W/ EPINEPHRINE
ANDA #086402		 SUPPL-13 EPINEPHRINE; LIDOCAINE HYDROCHLORIDE INTL MEDICATION Manufacturing (CMC) Approval
02/08/1993 LIDOCAINE HYDROCHLORIDE W/ EPINEPHRINE
ANDA #086402		 SUPPL-14 EPINEPHRINE; LIDOCAINE HYDROCHLORIDE INTL MEDICATION Manufacturing (CMC) Approval
02/08/1993 MEPIVACAINE HYDROCHLORIDE
ANDA #087509		 SUPPL-6 MEPIVACAINE HYDROCHLORIDE INTL MEDICATION SYS Manufacturing (CMC) Approval
02/09/1993 HEPARIN SODIUM
NDA #017037		 SUPPL-130 HEPARIN SODIUM HIKMA Manufacturing (CMC) Approval
02/09/1993 CEPHULAC
NDA #017657		 SUPPL-32 LACTULOSE SANOFI AVENTIS US Manufacturing (CMC) Approval
02/09/1993 DOBUTREX
NDA #017820		 SUPPL-26 DOBUTAMINE HYDROCHLORIDE LILLY Manufacturing (CMC) Approval
02/09/1993 BRETHINE
NDA #017849		 SUPPL-24 TERBUTALINE SULFATE ANI PHARMS Manufacturing (CMC) Approval
02/09/1993 PENTAM
NDA #019264		 SUPPL-13 PENTAMIDINE ISETHIONATE FRESENIUS KABI USA Labeling Approval
02/09/1993 TERAZOL 7
NDA #019579		 SUPPL-8 TERCONAZOLE JANSSEN PHARMS Manufacturing (CMC) Approval
02/09/1993 TERAZOL 3
NDA #019641		 SUPPL-7 TERCONAZOLE JANSSEN PHARMS Manufacturing (CMC) Approval
02/09/1993 CYTOVENE
NDA #019661		 SUPPL-3 GANCICLOVIR SODIUM CHEPLAPHARM Manufacturing (CMC) Approval
02/09/1993 TERAZOL 3
NDA #019964		 SUPPL-4 TERCONAZOLE JANSSEN PHARMS Manufacturing (CMC) Approval
02/09/1993 ZOFRAN
NDA #020007		 SUPPL-12 ONDANSETRON HYDROCHLORIDE SANDOZ Manufacturing (CMC) Approval
02/09/1993 ZOFRAN PRESERVATIVE FREE
NDA #020007		 SUPPL-12 ONDANSETRON HYDROCHLORIDE SANDOZ Manufacturing (CMC) Approval
02/09/1993 IBUPROFEN
ANDA #071807		 SUPPL-12 IBUPROFEN SANDOZ Manufacturing (CMC) Approval
02/09/1993 ALBUTEROL SULFATE
ANDA #072637		 SUPPL-5 ALBUTEROL SULFATE SUN PHARM INDUSTRIES Labeling Approval
02/09/1993 ISOSORBIDE DINITRATE
ANDA #088088		 SUPPL-14 ISOSORBIDE DINITRATE HIKMA INTL PHARMS Manufacturing (CMC) Approval
02/09/1993 ISOSORBIDE DINITRATE
ANDA #088088		 SUPPL-15 ISOSORBIDE DINITRATE HIKMA INTL PHARMS Manufacturing (CMC) Approval
02/09/1993 LIGNOSPAN FORTE
ANDA #088389		 SUPPL-15 EPINEPHRINE BITARTRATE; LIDOCAINE HYDROCHLORIDE DEPROCO Manufacturing (CMC) Approval
02/09/1993 LIGNOSPAN STANDARD
ANDA #088390		 SUPPL-17 EPINEPHRINE BITARTRATE; LIDOCAINE HYDROCHLORIDE DEPROCO Manufacturing (CMC) Approval
02/09/1993 POTASSIUM CHLORIDE IN PLASTIC CONTAINER
ANDA #088908		 SUPPL-13 POTASSIUM CHLORIDE FRESENIUS KABI USA Labeling Approval
02/10/1993 TRANSDERM SCOP
NDA #017874		 SUPPL-25 SCOPOLAMINE BAXTER HLTHCARE CORP Manufacturing (CMC) Approval
02/10/1993 HEXALEN
NDA #019926		 SUPPL-10 ALTRETAMINE EISAI INC Labeling Approval
02/10/1993 DIFLUCAN IN DEXTROSE 5% IN PLASTIC CONTAINER
NDA #019950		 SUPPL-9 FLUCONAZOLE PFIZER Manufacturing (CMC) Approval
02/10/1993 DIFLUCAN IN SODIUM CHLORIDE 0.9%
NDA #019950		 SUPPL-9 FLUCONAZOLE PFIZER Manufacturing (CMC) Approval
02/10/1993 DIFLUCAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #019950		 SUPPL-9 FLUCONAZOLE PFIZER Manufacturing (CMC) Approval
02/10/1993 ULTRAVATE
NDA #019967		 SUPPL-6 HALOBETASOL PROPIONATE SUN PHARM INDS INC Manufacturing (CMC) Approval
02/10/1993 ULTRAVATE
NDA #019968		 SUPPL-2 HALOBETASOL PROPIONATE SUN PHARM INDS INC Manufacturing (CMC) Approval
02/11/1993 CHORIONIC GONADOTROPIN
BLA #017016		 SUPPL-140 GONADOTROPIN, CHORIONIC FERRING Approval
02/11/1993 CHORIONIC GONADOTROPIN
BLA #017067		 SUPPL-51 GONADOTROPIN, CHORIONIC FRESENIUS KABI USA Approval
02/11/1993 TRENTAL
NDA #018631		 SUPPL-19 PENTOXIFYLLINE VALIDUS PHARMS Manufacturing (CMC) Approval
02/11/1993 SANDIMMUNE
NDA #050574		 SUPPL-9 CYCLOSPORINE NOVARTIS Manufacturing (CMC) Approval
02/11/1993 MYKACET
ANDA #062367		 SUPPL-7 NYSTATIN; TRIAMCINOLONE ACETONIDE COSETTE Manufacturing (CMC) Approval
02/11/1993 CLINDAMYCIN PHOSPHATE
ANDA #062930		 SUPPL-1 CLINDAMYCIN PHOSPHATE VINTAGE PHARMS Manufacturing (CMC) Approval
02/11/1993 CONSTULOSE
ANDA #070288		 SUPPL-16 LACTULOSE ACTAVIS MID ATLANTIC Manufacturing (CMC) Approval
02/11/1993 VALPROIC ACID
ANDA #070631		 SUPPL-11 VALPROIC ACID UPSHER SMITH LABS Labeling Approval
02/11/1993 TAB-PROFEN
ANDA #072095		 SUPPL-6 IBUPROFEN PERRIGO Manufacturing (CMC) Approval
02/11/1993 IBUPROFEN
ANDA #072096		 SUPPL-5 IBUPROFEN PERRIGO Manufacturing (CMC) Approval
02/11/1993 CAP-PROFEN
ANDA #072097		 SUPPL-3 IBUPROFEN PERRIGO Manufacturing (CMC) Approval
02/11/1993 IBUPROFEN
ANDA #072098		 SUPPL-5 IBUPROFEN PERRIGO Manufacturing (CMC) Approval
02/12/1993 LOTRIMIN
NDA #018813		 SUPPL-15 CLOTRIMAZOLE SCHERING Manufacturing (CMC) Approval
02/12/1993 METHYLDOPA
NDA #018934		 SUPPL-38 METHYLDOPA CHARTWELL RX Labeling Approval
02/12/1993 SELEGILINE HYDROCHLORIDE
NDA #019334		 SUPPL-11 SELEGILINE HYDROCHLORIDE SOMERSET Manufacturing (CMC) Approval
02/12/1993 CIPRO
NDA #019847		 SUPPL-7 CIPROFLOXACIN BAYER HLTHCARE Manufacturing (CMC) Approval
02/12/1993 HALFAN
NDA #020250		 SUPPL-3 HALOFANTRINE HYDROCHLORIDE GLAXOSMITHKLINE Labeling Approval
02/12/1993 CEFAZOLIN SODIUM
ANDA #063207		 SUPPL-2 CEFAZOLIN SODIUM FACTA FARMA Manufacturing (CMC) Approval
02/12/1993 CEFAZOLIN SODIUM
ANDA #063208		 SUPPL-2 CEFAZOLIN SODIUM STERI PHARMA Manufacturing (CMC) Approval
02/12/1993 CEFAZOLIN SODIUM
ANDA #063209		 SUPPL-2 CEFAZOLIN SODIUM FACTA FARMA Manufacturing (CMC) Approval
02/12/1993 CEFAZOLIN SODIUM
ANDA #063214		 SUPPL-2 CEFAZOLIN SODIUM FACTA FARMA Manufacturing (CMC) Approval
02/12/1993 CEFAZOLIN SODIUM
ANDA #063216		 SUPPL-2 CEFAZOLIN SODIUM STERI PHARMA Manufacturing (CMC) Approval
02/12/1993 MECLOFENAMATE SODIUM
ANDA #071469		 SUPPL-16 MECLOFENAMATE SODIUM ANI PHARMS Labeling Approval
02/12/1993 METHYLDOPA
ANDA #071700		 SUPPL-2 METHYLDOPA CHARTWELL RX Labeling Approval
02/12/1993 HYDROCHLOROTHIAZIDE
ANDA #083972		 SUPPL-170 HYDROCHLOROTHIAZIDE SUN PHARM INDUSTRIES Labeling Approval
02/12/1993 CHLOROTHIAZIDE-RESERPINE
ANDA #087744		 SUPPL-9 CHLOROTHIAZIDE; RESERPINE MYLAN Labeling Approval
02/12/1993 CHLOROTHIAZIDE-RESERPINE
ANDA #087745		 SUPPL-9 CHLOROTHIAZIDE; RESERPINE MYLAN Labeling Approval
02/12/1993 HYDROCORTISONE AND ACETIC ACID
ANDA #088759		 SUPPL-14 ACETIC ACID, GLACIAL; HYDROCORTISONE TARO Labeling Approval
02/16/1993 SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #019465		 SUPPL-15 SODIUM CHLORIDE HOSPIRA Labeling Approval
02/16/1993 DEXTROSE 5% IN PLASTIC CONTAINER
NDA #019466		 SUPPL-16 DEXTROSE HOSPIRA Labeling Approval
02/16/1993 SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
NDA #019759		 SUPPL-10 SODIUM CHLORIDE HOSPIRA Labeling Approval
02/16/1993 SANDIMMUNE
NDA #050574		 SUPPL-3 CYCLOSPORINE NOVARTIS Manufacturing (CMC) Approval
02/16/1993 LORABID
NDA #050667		 SUPPL-3 LORACARBEF KING PHARMS Manufacturing (CMC) Approval
02/16/1993 GRIFULVIN V
ANDA #062279		 SUPPL-15 GRISEOFULVIN, MICROCRYSTALLINE VALEANT LUXEMBOURG Labeling Approval
02/16/1993 GRIFULVIN V
ANDA #062279		 SUPPL-15 GRISEOFULVIN, MICROSIZE VALEANT LUXEMBOURG Labeling Approval
02/16/1993 NAFCILLIN SODIUM
ANDA #062844		 SUPPL-6 NAFCILLIN SODIUM WATSON LABS INC Manufacturing (CMC) Approval
02/16/1993 NAFCILLIN SODIUM
ANDA #063008		 SUPPL-5 NAFCILLIN SODIUM WATSON LABS INC Manufacturing (CMC) Approval
02/16/1993 LIDOCAINE
ANDA #086724		 SUPPL-14 LIDOCAINE TARO PHARMS Labeling Approval
02/16/1993 POLOCAINE
ANDA #089410		 SUPPL-2 MEPIVACAINE HYDROCHLORIDE FRESENIUS KABI USA Manufacturing (CMC) Approval
02/17/1993 WYAMINE SULFATE
NDA #008248		 SUPPL-5 MEPHENTERMINE SULFATE BAXTER HLTHCARE CORP Labeling Approval
02/17/1993 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE
NDA #017702		 SUPPL-19 LIDOCAINE HYDROCHLORIDE INTL MEDICATION Manufacturing (CMC) Approval
02/17/1993 LONITEN
NDA #018154		 SUPPL-18 MINOXIDIL PFIZER Labeling Approval
02/17/1993 HALOTHANE
ANDA #080810		 SUPPL-19 HALOTHANE HALOCARBON Manufacturing (CMC) Approval
02/17/1993 DIPHENHYDRAMINE HYDROCHLORIDE
ANDA #080817		 SUPPL-34 DIPHENHYDRAMINE HYDROCHLORIDE WEST-WARD PHARMS INT Labeling Approval
02/18/1993 ARALEN
NDA #006002		 SUPPL-32 CHLOROQUINE PHOSPHATE SANOFI AVENTIS US Labeling Approval
02/18/1993 ARALEN HYDROCHLORIDE
NDA #006002		 SUPPL-32 CHLOROQUINE HYDROCHLORIDE SANOFI AVENTIS US Labeling Approval
02/18/1993 XYLOCAINE
NDA #006488		 SUPPL-52 LIDOCAINE HYDROCHLORIDE FRESENIUS KABI USA Manufacturing (CMC) Approval
02/18/1993 XYLOCAINE W/ EPINEPHRINE
NDA #006488		 SUPPL-52 EPINEPHRINE; LIDOCAINE HYDROCHLORIDE FRESENIUS KABI USA Manufacturing (CMC) Approval
02/18/1993 XYLOCAINE
NDA #008048		 SUPPL-13 LIDOCAINE ASTRAZENECA Manufacturing (CMC) Approval
02/18/1993 XYLOCAINE
NDA #008816		 SUPPL-27 LIDOCAINE HYDROCHLORIDE EPIC PHARMA LLC Manufacturing (CMC) Approval
02/18/1993 XYLOCAINE VISCOUS
NDA #009470		 SUPPL-19 LIDOCAINE HYDROCHLORIDE FRESENIUS KABI USA Manufacturing (CMC) Approval
02/18/1993 XYLOCAINE 4% PRESERVATIVE FREE
NDA #010417		 SUPPL-17 LIDOCAINE HYDROCHLORIDE FRESENIUS KABI USA Manufacturing (CMC) Approval
02/18/1993 XYLOCAINE 5% W/ GLUCOSE 7.5%
NDA #010496		 SUPPL-16 LIDOCAINE HYDROCHLORIDE ASTRAZENECA Manufacturing (CMC) Approval
02/18/1993 XYLOCAINE
NDA #014127		 SUPPL-6 LIDOCAINE ASTRAZENECA Manufacturing (CMC) Approval
02/18/1993 XYLOCAINE 1.5% W/ DEXTROSE 7.5%
NDA #016297		 SUPPL-12 LIDOCAINE HYDROCHLORIDE FRESENIUS KABI USA Manufacturing (CMC) Approval
02/18/1993 XYLOCAINE PRESERVATIVE FREE
NDA #016801		 SUPPL-30 LIDOCAINE HYDROCHLORIDE FRESENIUS KABI USA Manufacturing (CMC) Approval
02/18/1993 LINCOCIN
NDA #050316		 SUPPL-8 LINCOMYCIN HYDROCHLORIDE PHARMACIA AND UPJOHN Manufacturing (CMC) Approval
02/18/1993 ZINACEF
NDA #050558		 SUPPL-36 CEFUROXIME SODIUM PAI HOLDINGS PHARM Manufacturing (CMC) Approval
02/18/1993 FORTAZ
NDA #050578		 SUPPL-29 CEFTAZIDIME PAI HOLDINGS PHARM Manufacturing (CMC) Approval
02/18/1993 AZACTAM
NDA #050580		 SUPPL-24 AZTREONAM BRISTOL MYERS SQUIBB Manufacturing (CMC) Approval
02/18/1993 ERYCETTE
NDA #050594		 SUPPL-17 ERYTHROMYCIN JOHNSON AND JOHNSON Manufacturing (CMC) Approval
02/18/1993 PROPRANOLOL HYDROCHLORIDE
ANDA #070175		 SUPPL-20 PROPRANOLOL HYDROCHLORIDE WATSON LABS Labeling Approval
02/18/1993 PROPRANOLOL HYDROCHLORIDE
ANDA #070176		 SUPPL-20 PROPRANOLOL HYDROCHLORIDE WATSON LABS Labeling Approval
02/18/1993 PROPRANOLOL HYDROCHLORIDE
ANDA #070177		 SUPPL-19 PROPRANOLOL HYDROCHLORIDE WATSON LABS Labeling Approval
02/18/1993 PROPRANOLOL HYDROCHLORIDE
ANDA #070178		 SUPPL-22 PROPRANOLOL HYDROCHLORIDE WATSON LABS Labeling Approval
02/18/1993 EPITOL
ANDA #070541		 SUPPL-19 CARBAMAZEPINE TEVA Labeling Approval
02/18/1993 PROPRANOLOL HYDROCHLORIDE
ANDA #071098		 SUPPL-14 PROPRANOLOL HYDROCHLORIDE WATSON LABS Labeling Approval
02/18/1993 PROPRANOLOL HYDROCHLORIDE
ANDA #071183		 SUPPL-13 PROPRANOLOL HYDROCHLORIDE WATSON LABS Labeling Approval
02/18/1993 ALBUTEROL SULFATE
ANDA #072894		 SUPPL-3 ALBUTEROL SULFATE DASH PHARMS NATCO Labeling Approval
02/19/1993 TOFRANIL-PM
NDA #017090		 SUPPL-59 IMIPRAMINE PAMOATE SPECGX LLC Manufacturing (CMC) Approval
02/19/1993 CATAPRES-TTS-1
NDA #018891		 SUPPL-14 CLONIDINE LAVIPHARM Manufacturing (CMC) Approval
02/19/1993 CATAPRES-TTS-2
NDA #018891		 SUPPL-14 CLONIDINE LAVIPHARM Manufacturing (CMC) Approval
02/19/1993 CATAPRES-TTS-3
NDA #018891		 SUPPL-14 CLONIDINE LAVIPHARM Manufacturing (CMC) Approval
02/19/1993 LAC-HYDRIN
NDA #019155		 SUPPL-10 AMMONIUM LACTATE SUN PHARM INDS INC Manufacturing (CMC) Approval
02/19/1993 SHADE UVAGUARD
NDA #020045		 SUPPL-1 AVOBENZONE; OCTINOXATE; OXYBENZONE BAYER HEALTHCARE LLC Manufacturing (CMC) Approval
02/19/1993 DOXYCYCLINE HYCLATE
ANDA #062479		 SUPPL-14 DOXYCYCLINE HYCLATE RANBAXY Labeling Approval
02/19/1993 CHLORAMPHENICOL
ANDA #062628		 SUPPL-9 CHLORAMPHENICOL ALCON Labeling Approval
02/19/1993 CEFAZOLIN SODIUM
ANDA #063207		 SUPPL-3 CEFAZOLIN SODIUM FACTA FARMA Manufacturing (CMC) Approval
02/19/1993 CEFAZOLIN SODIUM
ANDA #063208		 SUPPL-3 CEFAZOLIN SODIUM STERI PHARMA Manufacturing (CMC) Approval
02/19/1993 CEFAZOLIN SODIUM
ANDA #063209		 SUPPL-3 CEFAZOLIN SODIUM FACTA FARMA Manufacturing (CMC) Approval
02/19/1993 CEFAZOLIN SODIUM
ANDA #063214		 SUPPL-3 CEFAZOLIN SODIUM FACTA FARMA Manufacturing (CMC) Approval
02/19/1993 CEFAZOLIN SODIUM
ANDA #063216		 SUPPL-3 CEFAZOLIN SODIUM STERI PHARMA Manufacturing (CMC) Approval
02/19/1993 CARBAMAZEPINE
ANDA #071479		 SUPPL-7 CARBAMAZEPINE PLIVA Labeling Approval
02/19/1993 PANCURONIUM BROMIDE
ANDA #072058		 SUPPL-7 PANCURONIUM BROMIDE ELKINS SINN Labeling Approval
02/19/1993 PANCURONIUM BROMIDE
ANDA #072059		 SUPPL-9 PANCURONIUM BROMIDE ELKINS SINN Labeling Approval
02/19/1993 PANCURONIUM BROMIDE
ANDA #072060		 SUPPL-8 PANCURONIUM BROMIDE ELKINS SINN Labeling Approval
02/19/1993 POLOCAINE W/ LEVONORDEFRIN
ANDA #089517		 SUPPL-2 LEVONORDEFRIN; MEPIVACAINE HYDROCHLORIDE DENTSPLY PHARM Manufacturing (CMC) Approval
02/22/1993 SEPTRA
NDA #017376		 SUPPL-46 SULFAMETHOXAZOLE; TRIMETHOPRIM MONARCH PHARMS Manufacturing (CMC) Approval
02/22/1993 SEPTRA DS
NDA #017376		 SUPPL-46 SULFAMETHOXAZOLE; TRIMETHOPRIM MONARCH PHARMS Manufacturing (CMC) Approval
02/22/1993 SEPTRA
NDA #017598		 SUPPL-31 SULFAMETHOXAZOLE; TRIMETHOPRIM MONARCH PHARMS Manufacturing (CMC) Approval
02/22/1993 SEPTRA GRAPE
NDA #017598		 SUPPL-31 SULFAMETHOXAZOLE; TRIMETHOPRIM MONARCH PHARMS Manufacturing (CMC) Approval
02/22/1993 MIACALCIN
NDA #017808		 SUPPL-8 CALCITONIN SALMON MYLAN IRELAND LTD Manufacturing (CMC) Approval
02/22/1993 MYCELEX-7
NDA #018182		 SUPPL-10 CLOTRIMAZOLE BAYER HEALTHCARE LLC Manufacturing (CMC) Approval
02/22/1993 MYCELEX-7
NDA #018230		 SUPPL-10 CLOTRIMAZOLE BAYER HEALTHCARE LLC Manufacturing (CMC) Approval
02/22/1993 SEPTRA
NDA #018452		 SUPPL-19 SULFAMETHOXAZOLE; TRIMETHOPRIM MONARCH PHARMS Manufacturing (CMC) Approval
02/22/1993 WESTCORT
NDA #018726		 SUPPL-8 HYDROCORTISONE VALERATE SUN PHARM INDS INC Manufacturing (CMC) Approval
02/22/1993 M.V.I. PEDIATRIC
NDA #018920		 SUPPL-8 ASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; DEXPANTHENOL; ERGOCALCIFEROL; FOLIC ACID; NIACINAMIDE; PHYTONADIONE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN 5'-PHOSPHATE SODIUM; THIAMINE HYDROCHLORIDE; VITAMIN A; VITAMIN E HOSPIRA Labeling Approval
02/22/1993 PHOSLO
NDA #019976		 SUPPL-1 CALCIUM ACETATE FRESENIUS MEDCL Manufacturing (CMC) Approval
02/22/1993 ZOFRAN
NDA #020103		 SUPPL-1 ONDANSETRON HYDROCHLORIDE SANDOZ Labeling Approval
02/22/1993 ROCEPHIN W/ DEXTROSE IN PLASTIC CONTAINER
NDA #050624		 SUPPL-16 CEFTRIAXONE SODIUM HOFFMANN LA ROCHE Labeling Approval
02/22/1993 CARBAMAZEPINE
ANDA #070231		 SUPPL-7 CARBAMAZEPINE INWOOD LABS Manufacturing (CMC) Approval
02/22/1993 PROPRANOLOL HYDROCHLORIDE
ANDA #072499		 SUPPL-3 PROPRANOLOL HYDROCHLORIDE INWOOD LABS Manufacturing (CMC) Approval
02/22/1993 PROPRANOLOL HYDROCHLORIDE
ANDA #072500		 SUPPL-4 PROPRANOLOL HYDROCHLORIDE INWOOD LABS Manufacturing (CMC) Approval
02/22/1993 PROPRANOLOL HYDROCHLORIDE
ANDA #072501		 SUPPL-3 PROPRANOLOL HYDROCHLORIDE INWOOD LABS Manufacturing (CMC) Approval
02/22/1993 PROPRANOLOL HYDROCHLORIDE
ANDA #072502		 SUPPL-3 PROPRANOLOL HYDROCHLORIDE INWOOD LABS Manufacturing (CMC) Approval
02/22/1993 LEUCOVORIN CALCIUM
ANDA #072733		 ORIG-1 LEUCOVORIN CALCIUM HIKMA Approval
02/22/1993 LEUCOVORIN CALCIUM
ANDA #072734		 ORIG-1 LEUCOVORIN CALCIUM HIKMA Approval
02/22/1993 LEUCOVORIN CALCIUM
ANDA #072735		 ORIG-1 LEUCOVORIN CALCIUM HIKMA Approval
02/22/1993 LEUCOVORIN CALCIUM
ANDA #072736		 ORIG-1 LEUCOVORIN CALCIUM HIKMA Approval
02/22/1993 ELIXOPHYLLIN
ANDA #085186		 SUPPL-17 THEOPHYLLINE NOSTRUM LABS INC Manufacturing (CMC) Approval
02/22/1993 THEOCHRON
ANDA #087400		 SUPPL-23 THEOPHYLLINE NOSTRUM PHARMS LLC Manufacturing (CMC) Approval
02/22/1993 ANTABUSE
ANDA #088482		 SUPPL-8 DISULFIRAM ODYSSEY PHARMS Labeling Approval
02/22/1993 ANTABUSE
ANDA #088483		 SUPPL-7 DISULFIRAM ODYSSEY PHARMS Labeling Approval
02/23/1993 THIOTEPA
NDA #011683		 SUPPL-23 THIOTEPA IMMUNEX Labeling Approval
02/23/1993 AN-DTPA
NDA #017714		 SUPPL-19 TECHNETIUM TC-99M PENTETATE KIT JUBILANT DRAXIMAGE Manufacturing (CMC) Approval
02/23/1993 PARAPLATIN
NDA #019880		 SUPPL-7 CARBOPLATIN CORDEN PHARMA Labeling Approval
02/23/1993 BLENOXANE
NDA #050443		 SUPPL-23 BLEOMYCIN SULFATE BRISTOL MYERS SQUIBB Labeling Approval
02/23/1993 SEROMYCIN
ANDA #060593		 SUPPL-20 CYCLOSERINE CEROVENE INC Bioequivalence Approval
02/23/1993 PROMPT PHENYTOIN SODIUM
ANDA #080259		 SUPPL-39 PHENYTOIN SODIUM ANI PHARMS Manufacturing (CMC) Approval
02/23/1993 PROMPT PHENYTOIN SODIUM
ANDA #080259		 SUPPL-40 PHENYTOIN SODIUM ANI PHARMS Manufacturing (CMC) Approval
02/24/1993 M.V.I.-12 ADULT
NDA #008809		 SUPPL-29 ASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; DEXPANTHENOL; ERGOCALCIFEROL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN 5'-PHOSPHATE SODIUM; THIAMINE HYDROCHLORIDE; VITAMIN A; VITAMIN E HOSPIRA Manufacturing (CMC) Approval
02/24/1993 M.V.I.-12 ADULT
NDA #008809		 SUPPL-29 ASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; DEXPANTHENOL; ERGOCALCIFEROL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; THIAMINE HYDROCHLORIDE; VITAMIN A; VITAMIN E HOSPIRA Manufacturing (CMC) Approval
02/24/1993 PREMARIN
NDA #010402		 SUPPL-32 ESTROGENS, CONJUGATED WYETH PHARMS Labeling Approval
02/24/1993 M.V.I. PEDIATRIC
NDA #018920		 SUPPL-9 ASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; DEXPANTHENOL; ERGOCALCIFEROL; FOLIC ACID; NIACINAMIDE; PHYTONADIONE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN 5'-PHOSPHATE SODIUM; THIAMINE HYDROCHLORIDE; VITAMIN A; VITAMIN E HOSPIRA Manufacturing (CMC) Approval
02/24/1993 VASOTEC
NDA #018998		 SUPPL-36 ENALAPRIL MALEATE BAUSCH Labeling Approval
02/24/1993 VASERETIC
NDA #019221		 SUPPL-14 ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE BAUSCH Labeling Approval
02/24/1993 VASOTEC
NDA #019309		 SUPPL-13 ENALAPRILAT BIOVAIL LABS INTL Labeling Approval
02/24/1993 SANDIMMUNE
NDA #050574		 SUPPL-4 CYCLOSPORINE NOVARTIS Manufacturing (CMC) Approval
02/25/1993 SULFAMETHOXAZOLE AND TRIMETHOPRIM
NDA #018852		 SUPPL-19 SULFAMETHOXAZOLE; TRIMETHOPRIM WATSON LABS Manufacturing (CMC) Approval
02/25/1993 SULFAMETHOXAZOLE AND TRIMETHOPRIM DOUBLE STRENGTH
NDA #018854		 SUPPL-26 SULFAMETHOXAZOLE; TRIMETHOPRIM WATSON LABS Manufacturing (CMC) Approval
02/25/1993 DISOPYRAMIDE PHOSPHATE
ANDA #071200		 SUPPL-9 DISOPYRAMIDE PHOSPHATE NESHER PHARMS Manufacturing (CMC) Approval
02/25/1993 CYTARABINE
ANDA #072168		 SUPPL-1 CYTARABINE HOSPIRA Manufacturing (CMC) Approval
02/25/1993 HALOPERIDOL
ANDA #072516		 ORIG-1 HALOPERIDOL LACTATE MARSAM PHARMS LLC Approval
02/25/1993 HALOPERIDOL
ANDA #072517		 ORIG-1 HALOPERIDOL LACTATE MARSAM PHARMS LLC Approval
02/25/1993 PROMETHAZINE HYDROCHLORIDE
ANDA #084591		 SUPPL-78 PROMETHAZINE HYDROCHLORIDE WATSON LABS Manufacturing (CMC) Approval
02/25/1993 HYDROCHLOROTHIAZIDE
ANDA #085022		 SUPPL-13 HYDROCHLOROTHIAZIDE IVAX SUB TEVA PHARMS Manufacturing (CMC) Approval
02/25/1993 IMIPRAMINE HYDROCHLORIDE
ANDA #087846		 SUPPL-12 IMIPRAMINE HYDROCHLORIDE SPECGX LLC Manufacturing (CMC) Approval
02/25/1993 TOFRANIL
ANDA #087846		 SUPPL-12 IMIPRAMINE HYDROCHLORIDE SPECGX LLC Manufacturing (CMC) Approval
02/25/1993 CHLORPROPAMIDE
ANDA #088921		 SUPPL-12 CHLORPROPAMIDE ANI PHARMS Labeling Approval
02/25/1993 CHLORPROPAMIDE
ANDA #088922		 SUPPL-13 CHLORPROPAMIDE ANI PHARMS Labeling Approval
02/25/1993 ESGIC-PLUS
ANDA #089451		 SUPPL-12 ACETAMINOPHEN; BUTALBITAL; CAFFEINE MIKART Manufacturing (CMC) Approval
02/25/1993 ESGIC-PLUS
ANDA #089451		 SUPPL-13 ACETAMINOPHEN; BUTALBITAL; CAFFEINE MIKART Manufacturing (CMC) Approval
02/25/1993 ESGIC-PLUS
ANDA #089451		 SUPPL-14 ACETAMINOPHEN; BUTALBITAL; CAFFEINE MIKART Labeling Approval
02/25/1993 ESGIC-PLUS
ANDA #089451		 SUPPL-15 ACETAMINOPHEN; BUTALBITAL; CAFFEINE MIKART Manufacturing (CMC) Approval
02/25/1993 ESGIC-PLUS
ANDA #089451		 SUPPL-16 ACETAMINOPHEN; BUTALBITAL; CAFFEINE MIKART Manufacturing (CMC) Approval
02/25/1993 ESGIC-PLUS
ANDA #089451		 SUPPL-17 ACETAMINOPHEN; BUTALBITAL; CAFFEINE MIKART Labeling Approval
02/25/1993 HYDROCODONE BITARTRATE AND ACETAMINOPHEN
ANDA #089689		 SUPPL-12 ACETAMINOPHEN; HYDROCODONE BITARTRATE MIKART Manufacturing (CMC) Approval
02/25/1993 HYDROCODONE BITARTRATE AND ACETAMINOPHEN
ANDA #089689		 SUPPL-13 ACETAMINOPHEN; HYDROCODONE BITARTRATE MIKART Manufacturing (CMC) Approval
02/25/1993 HYDROCODONE BITARTRATE AND ACETAMINOPHEN
ANDA #089689		 SUPPL-14 ACETAMINOPHEN; HYDROCODONE BITARTRATE MIKART Labeling Approval
02/25/1993 HYDROCODONE BITARTRATE AND ACETAMINOPHEN
ANDA #089689		 SUPPL-26 ACETAMINOPHEN; HYDROCODONE BITARTRATE MIKART Manufacturing (CMC) Approval
02/25/1993 HYDROCODONE BITARTRATE AND ACETAMINOPHEN
ANDA #089689		 SUPPL-27 ACETAMINOPHEN; HYDROCODONE BITARTRATE MIKART Manufacturing (CMC) Approval
02/25/1993 HYDROCODONE BITARTRATE AND ACETAMINOPHEN
ANDA #089698		 SUPPL-8 ACETAMINOPHEN; HYDROCODONE BITARTRATE MIKART Manufacturing (CMC) Approval
02/25/1993 HYDROCODONE BITARTRATE AND ACETAMINOPHEN
ANDA #089698		 SUPPL-9 ACETAMINOPHEN; HYDROCODONE BITARTRATE MIKART Manufacturing (CMC) Approval
02/25/1993 HYDROCODONE BITARTRATE AND ACETAMINOPHEN
ANDA #089699		 SUPPL-12 ACETAMINOPHEN; HYDROCODONE BITARTRATE MIKART Manufacturing (CMC) Approval
02/25/1993 HYDROCODONE BITARTRATE AND ACETAMINOPHEN
ANDA #089699		 SUPPL-14 ACETAMINOPHEN; HYDROCODONE BITARTRATE MIKART Manufacturing (CMC) Approval
02/26/1993 PHENERGAN
NDA #008857		 SUPPL-16 PROMETHAZINE HYDROCHLORIDE WYETH AYERST Manufacturing (CMC) Approval
02/26/1993 VERSED
NDA #018654		 SUPPL-22 MIDAZOLAM HYDROCHLORIDE HLR Manufacturing (CMC) Approval
02/26/1993 VERSED
NDA #018654		 SUPPL-23 MIDAZOLAM HYDROCHLORIDE HLR Manufacturing (CMC) Approval
02/26/1993 ADVIL
NDA #018989		 SUPPL-33 IBUPROFEN HALEON US HOLDINGS Manufacturing (CMC) Approval
02/26/1993 TECHNESCAN MAG3
NDA #019882		 SUPPL-2 TECHNETIUM TC-99M MERTIATIDE KIT CURIUM Labeling Approval
02/26/1993 BUPIVACAINE HYDROCHLORIDE KIT
NDA #019978		 SUPPL-1 BUPIVACAINE HYDROCHLORIDE HOSPIRA Manufacturing (CMC) Approval
02/26/1993 LEUSTATIN
NDA #020229		 ORIG-1 CLADRIBINE JANSSEN PHARMS Type 1 - New Molecular Entity Approval
02/26/1993 LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE
ANDA #040057		 ORIG-1 EPINEPHRINE; LIDOCAINE HYDROCHLORIDE EASTMAN KODAK Approval
02/26/1993 PENICILLIN-VK
ANDA #060456		 SUPPL-30 PENICILLIN V POTASSIUM TEVA Labeling Approval
02/26/1993 PENICILLIN-VK
ANDA #060711		 SUPPL-18 PENICILLIN V POTASSIUM TEVA Labeling Approval
02/26/1993 TICAR
ANDA #062690		 SUPPL-3 TICARCILLIN DISODIUM GLAXOSMITHKLINE Labeling Approval
02/26/1993 CEFUROXIME SODIUM
ANDA #064035		 ORIG-1 CEFUROXIME SODIUM WATSON LABS INC Approval
02/26/1993 CEFUROXIME SODIUM
ANDA #064036		 ORIG-1 CEFUROXIME SODIUM WATSON LABS INC Approval
02/26/1993 FLUOCINONIDE
ANDA #071500		 SUPPL-18 FLUOCINONIDE TARO PHARMS Labeling Approval
02/26/1993 VERAPAMIL HYDROCHLORIDE
ANDA #072233		 ORIG-1 VERAPAMIL HYDROCHLORIDE MARSAM PHARMS LLC Approval
02/26/1993 HALOPERIDOL
ANDA #073037		 ORIG-1 HALOPERIDOL LACTATE PHARM ASSOC Approval
02/26/1993 CYCLOBENZAPRINE HYDROCHLORIDE
ANDA #073683		 ORIG-1 CYCLOBENZAPRINE HYDROCHLORIDE SANDOZ Approval
02/26/1993 PINDOLOL
ANDA #073687		 ORIG-1 PINDOLOL COSETTE Approval
02/26/1993 LORTAB
ANDA #087722		 SUPPL-31 ACETAMINOPHEN; HYDROCODONE BITARTRATE UCB INC Manufacturing (CMC) Approval
02/26/1993 LORTAB
ANDA #087722		 SUPPL-32 ACETAMINOPHEN; HYDROCODONE BITARTRATE UCB INC Manufacturing (CMC) Approval
02/26/1993 EPINEPHRINE
ANDA #087907		 SUPPL-12 EPINEPHRINE ARMSTRONG PHARMS Manufacturing (CMC) Approval
02/26/1993 EPINEPHRINE
ANDA #087907		 SUPPL-13 EPINEPHRINE ARMSTRONG PHARMS Manufacturing (CMC) Approval
02/26/1993 EPINEPHRINE
ANDA #087907		 SUPPL-14 EPINEPHRINE ARMSTRONG PHARMS Manufacturing (CMC) Approval
02/26/1993 EPINEPHRINE
ANDA #087907		 SUPPL-15 EPINEPHRINE ARMSTRONG PHARMS Manufacturing (CMC) Approval
02/26/1993 PROMETHAZINE VC W/ CODEINE
ANDA #088816		 SUPPL-2 CODEINE PHOSPHATE; PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE CENCI Labeling Approval
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