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Drugs@FDA: FDA-Approved Drugs

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All Approvals and Tentative Approvals
March 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 April 19, 2024.

Approval Date Drug Name Submission Active Ingredients Company Submission Classification * Submission Status
03/01/1993 DANOCRINE
NDA #017557		 SUPPL-29 DANAZOL SANOFI AVENTIS US Labeling Approval
03/01/1993 TRIMETHOPRIM
NDA #018679		 SUPPL-16 TRIMETHOPRIM DR REDDYS LABS SA Manufacturing (CMC) Approval
03/01/1993 OMNIPAQUE 12
NDA #018956		 SUPPL-31 IOHEXOL GE HEALTHCARE Manufacturing (CMC) Approval
03/01/1993 OMNIPAQUE 12
NDA #018956		 SUPPL-32 IOHEXOL GE HEALTHCARE Manufacturing (CMC) Approval
03/01/1993 OMNIPAQUE 12
NDA #018956		 SUPPL-33 IOHEXOL GE HEALTHCARE Labeling Approval
03/01/1993 OMNIPAQUE 12
NDA #018956		 SUPPL-34 IOHEXOL GE HEALTHCARE Manufacturing (CMC) Approval
03/01/1993 OMNIPAQUE 140
NDA #018956		 SUPPL-31 IOHEXOL GE HEALTHCARE Manufacturing (CMC) Approval
03/01/1993 OMNIPAQUE 140
NDA #018956		 SUPPL-32 IOHEXOL GE HEALTHCARE Manufacturing (CMC) Approval
03/01/1993 OMNIPAQUE 140
NDA #018956		 SUPPL-33 IOHEXOL GE HEALTHCARE Labeling Approval
03/01/1993 OMNIPAQUE 140
NDA #018956		 SUPPL-34 IOHEXOL GE HEALTHCARE Manufacturing (CMC) Approval
03/01/1993 OMNIPAQUE 180
NDA #018956		 SUPPL-31 IOHEXOL GE HEALTHCARE Manufacturing (CMC) Approval
03/01/1993 OMNIPAQUE 180
NDA #018956		 SUPPL-32 IOHEXOL GE HEALTHCARE Manufacturing (CMC) Approval
03/01/1993 OMNIPAQUE 180
NDA #018956		 SUPPL-33 IOHEXOL GE HEALTHCARE Labeling Approval
03/01/1993 OMNIPAQUE 180
NDA #018956		 SUPPL-34 IOHEXOL GE HEALTHCARE Manufacturing (CMC) Approval
03/01/1993 OMNIPAQUE 210
NDA #018956		 SUPPL-31 IOHEXOL GE HEALTHCARE Manufacturing (CMC) Approval
03/01/1993 OMNIPAQUE 210
NDA #018956		 SUPPL-32 IOHEXOL GE HEALTHCARE Manufacturing (CMC) Approval
03/01/1993 OMNIPAQUE 210
NDA #018956		 SUPPL-33 IOHEXOL GE HEALTHCARE Labeling Approval
03/01/1993 OMNIPAQUE 210
NDA #018956		 SUPPL-34 IOHEXOL GE HEALTHCARE Manufacturing (CMC) Approval
03/01/1993 OMNIPAQUE 240
NDA #018956		 SUPPL-31 IOHEXOL GE HEALTHCARE Manufacturing (CMC) Approval
03/01/1993 OMNIPAQUE 240
NDA #018956		 SUPPL-32 IOHEXOL GE HEALTHCARE Manufacturing (CMC) Approval
03/01/1993 OMNIPAQUE 240
NDA #018956		 SUPPL-33 IOHEXOL GE HEALTHCARE Labeling Approval
03/01/1993 OMNIPAQUE 240
NDA #018956		 SUPPL-34 IOHEXOL GE HEALTHCARE Manufacturing (CMC) Approval
03/01/1993 OMNIPAQUE 300
NDA #018956		 SUPPL-31 IOHEXOL GE HEALTHCARE Manufacturing (CMC) Approval
03/01/1993 OMNIPAQUE 300
NDA #018956		 SUPPL-32 IOHEXOL GE HEALTHCARE Manufacturing (CMC) Approval
03/01/1993 OMNIPAQUE 300
NDA #018956		 SUPPL-33 IOHEXOL GE HEALTHCARE Labeling Approval
03/01/1993 OMNIPAQUE 300
NDA #018956		 SUPPL-34 IOHEXOL GE HEALTHCARE Manufacturing (CMC) Approval
03/01/1993 OMNIPAQUE 350
NDA #018956		 SUPPL-31 IOHEXOL GE HEALTHCARE Manufacturing (CMC) Approval
03/01/1993 OMNIPAQUE 350
NDA #018956		 SUPPL-32 IOHEXOL GE HEALTHCARE Manufacturing (CMC) Approval
03/01/1993 OMNIPAQUE 350
NDA #018956		 SUPPL-33 IOHEXOL GE HEALTHCARE Labeling Approval
03/01/1993 OMNIPAQUE 350
NDA #018956		 SUPPL-34 IOHEXOL GE HEALTHCARE Manufacturing (CMC) Approval
03/01/1993 OMNIPAQUE 70
NDA #018956		 SUPPL-31 IOHEXOL GE HEALTHCARE Manufacturing (CMC) Approval
03/01/1993 OMNIPAQUE 70
NDA #018956		 SUPPL-32 IOHEXOL GE HEALTHCARE Manufacturing (CMC) Approval
03/01/1993 OMNIPAQUE 70
NDA #018956		 SUPPL-33 IOHEXOL GE HEALTHCARE Labeling Approval
03/01/1993 OMNIPAQUE 70
NDA #018956		 SUPPL-34 IOHEXOL GE HEALTHCARE Manufacturing (CMC) Approval
03/01/1993 OMNIPAQUE 9
NDA #018956		 SUPPL-31 IOHEXOL GE HEALTHCARE Manufacturing (CMC) Approval
03/01/1993 OMNIPAQUE 9
NDA #018956		 SUPPL-32 IOHEXOL GE HEALTHCARE Manufacturing (CMC) Approval
03/01/1993 OMNIPAQUE 9
NDA #018956		 SUPPL-33 IOHEXOL GE HEALTHCARE Labeling Approval
03/01/1993 OMNIPAQUE 9
NDA #018956		 SUPPL-34 IOHEXOL GE HEALTHCARE Manufacturing (CMC) Approval
03/01/1993 ROCEPHIN W/ DEXTROSE IN PLASTIC CONTAINER
NDA #050624		 SUPPL-13 CEFTRIAXONE SODIUM HOFFMANN LA ROCHE Manufacturing (CMC) Approval
03/01/1993 FORTAZ IN PLASTIC CONTAINER
NDA #050634		 SUPPL-2 CEFTAZIDIME SODIUM PAI HOLDINGS PHARM Manufacturing (CMC) Approval
03/01/1993 ERYTHROMYCIN
ANDA #062563		 SUPPL-16 ERYTHROMYCIN LACTOBIONATE ELKINS SINN Labeling Approval
03/01/1993 TRIMETHOPRIM
ANDA #071259		 SUPPL-3 TRIMETHOPRIM TEVA Manufacturing (CMC) Approval
03/01/1993 ALBUTEROL SULFATE
ANDA #072619		 SUPPL-6 ALBUTEROL SULFATE TEVA Labeling Approval
03/01/1993 ALBUTEROL SULFATE
ANDA #072620		 SUPPL-4 ALBUTEROL SULFATE TEVA Labeling Approval
03/01/1993 METAPROTERENOL SULFATE
ANDA #073632		 SUPPL-3 METAPROTERENOL SULFATE GENUS Manufacturing (CMC) Approval
03/01/1993 CHLOROTHIAZIDE
ANDA #084217		 SUPPL-188 CHLOROTHIAZIDE MYLAN Labeling Approval
03/01/1993 HYDROCHLOROTHIAZIDE
ANDA #088587		 SUPPL-6 HYDROCHLOROTHIAZIDE ROXANE Labeling Approval
03/02/1993 DIURIL
NDA #011145		 SUPPL-73 CHLOROTHIAZIDE RISING Labeling Approval
03/02/1993 DIURIL
NDA #011145		 SUPPL-74 CHLOROTHIAZIDE RISING Labeling Approval
03/02/1993 DIURIL
NDA #011145		 SUPPL-79 CHLOROTHIAZIDE RISING Labeling Approval
03/02/1993 DIURIL
NDA #011145		 SUPPL-73 CHLOROTHIAZIDE SODIUM RISING Labeling Approval
03/02/1993 DIURIL
NDA #011145		 SUPPL-74 CHLOROTHIAZIDE SODIUM RISING Labeling Approval
03/02/1993 DIURIL
NDA #011145		 SUPPL-79 CHLOROTHIAZIDE SODIUM RISING Labeling Approval
03/02/1993 DIURIL
NDA #011870		 SUPPL-27 CHLOROTHIAZIDE SALIX PHARMS Labeling Approval
03/02/1993 GLEOSTINE
NDA #017588		 SUPPL-30 LOMUSTINE LATINA PHARMA Manufacturing (CMC) Approval
03/02/1993 VEPESID
NDA #019557		 SUPPL-14 ETOPOSIDE STRIDES PHARMA Manufacturing (CMC) Approval
03/02/1993 CERETEC
NDA #019829		 SUPPL-1 TECHNETIUM TC-99M EXAMETAZIME KIT GE HEALTHCARE Manufacturing (CMC) Approval
03/02/1993 TOBRAMYCIN SULFATE
ANDA #063100		 SUPPL-2 TOBRAMYCIN SULFATE TEVA PHARMS USA Labeling Approval
03/04/1993 OPHTHETIC
NDA #012583		 SUPPL-26 PROPARACAINE HYDROCHLORIDE ALLERGAN Manufacturing (CMC) Approval
03/04/1993 EFUDEX
NDA #016831		 SUPPL-30 FLUOROURACIL BAUSCH Manufacturing (CMC) Approval
03/04/1993 PRED MILD
NDA #017100		 SUPPL-27 PREDNISOLONE ACETATE ABBVIE Manufacturing (CMC) Approval
03/04/1993 CORZIDE
NDA #018647		 SUPPL-7 BENDROFLUMETHIAZIDE; NADOLOL KING PHARMS LLC Manufacturing (CMC) Approval
03/04/1993 VIRAZOLE
NDA #018859		 SUPPL-16 RIBAVIRIN BAUSCH Manufacturing (CMC) Approval
03/04/1993 INDOMETHACIN
ANDA #073314		 SUPPL-1 INDOMETHACIN COSETTE Labeling Approval
03/04/1993 MEPIVACAINE HYDROCHLORIDE
ANDA #083559		 SUPPL-22 MEPIVACAINE HYDROCHLORIDE BELMORA LLC Labeling Approval
03/04/1993 DILOR
ANDA #084514		 SUPPL-26 DYPHYLLINE SAVAGE LABS Manufacturing (CMC) Approval
03/04/1993 DILOR-400
ANDA #084751		 SUPPL-25 DYPHYLLINE SAVAGE LABS Manufacturing (CMC) Approval
03/04/1993 SLO-PHYLLIN
ANDA #085187		 SUPPL-22 THEOPHYLLINE SANOFI AVENTIS US Manufacturing (CMC) Approval
03/04/1993 SLO-PHYLLIN
ANDA #085187		 SUPPL-23 THEOPHYLLINE SANOFI AVENTIS US Labeling Approval
03/04/1993 SLO-PHYLLIN
ANDA #085187		 SUPPL-24 THEOPHYLLINE SANOFI AVENTIS US Manufacturing (CMC) Approval
03/04/1993 ACETAMINOPHEN AND CODEINE PHOSPHATE
ANDA #085861		 SUPPL-41 ACETAMINOPHEN; CODEINE PHOSPHATE ACTAVIS MID ATLANTIC Labeling Approval
03/04/1993 NANDROLONE DECANOATE
ANDA #086385		 SUPPL-23 NANDROLONE DECANOATE WATSON LABS Labeling Approval
03/04/1993 LINDANE
ANDA #087313		 SUPPL-22 LINDANE OLTA PHARMS Labeling Approval
03/04/1993 NANDROLONE DECANOATE
ANDA #088128		 SUPPL-10 NANDROLONE DECANOATE WATSON LABS Labeling Approval
03/04/1993 CYCRIN
ANDA #089386		 SUPPL-10 MEDROXYPROGESTERONE ACETATE ESI Manufacturing (CMC) Approval
03/05/1993 FLAGYL I.V.
NDA #018353		 SUPPL-25 METRONIDAZOLE HYDROCHLORIDE PFIZER Manufacturing (CMC) Approval
03/05/1993 FLAGYL I.V. RTU IN PLASTIC CONTAINER
NDA #018353		 SUPPL-25 METRONIDAZOLE PFIZER Manufacturing (CMC) Approval
03/05/1993 SULFATRIM
NDA #018615		 SUPPL-32 SULFAMETHOXAZOLE; TRIMETHOPRIM PHARM ASSOC Bioequivalence Approval
03/05/1993 SULFATRIM PEDIATRIC
NDA #018615		 SUPPL-32 SULFAMETHOXAZOLE; TRIMETHOPRIM PHARM ASSOC Bioequivalence Approval
03/05/1993 COLYTE
NDA #018983		 SUPPL-14 POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUS MYLAN SPECIALITY LP Manufacturing (CMC) Approval
03/05/1993 COLYTE WITH FLAVOR PACKS
NDA #018983		 SUPPL-14 POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUS MYLAN SPECIALITY LP Manufacturing (CMC) Approval
03/05/1993 COLYTE-FLAVORED
NDA #018983		 SUPPL-14 POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUS MYLAN SPECIALITY LP Manufacturing (CMC) Approval
03/05/1993 TEMOVATE
NDA #019322		 SUPPL-11 CLOBETASOL PROPIONATE FOUGERA PHARMS Manufacturing (CMC) Approval
03/05/1993 TEMOVATE
NDA #019323		 SUPPL-12 CLOBETASOL PROPIONATE FOUGERA PHARMS Manufacturing (CMC) Approval
03/05/1993 CLEOCIN HYDROCHLORIDE
NDA #050162		 SUPPL-21 CLINDAMYCIN HYDROCHLORIDE PFIZER Manufacturing (CMC) Approval
03/05/1993 VINCASAR PFS
ANDA #071426		 SUPPL-21 VINCRISTINE SULFATE TEVA PARENTERAL Labeling Approval
03/05/1993 HYDROCODONE BITARTRATE AND ACETAMINOPHEN
ANDA #089006		 SUPPL-25 ACETAMINOPHEN; HYDROCODONE BITARTRATE MALLINCKRODT Bioequivalence Approval
03/08/1993 DIPRIVAN
NDA #019627		 SUPPL-10 PROPOFOL FRESENIUS KABI USA Efficacy Approval
03/08/1993 LORABID
NDA #050667		 SUPPL-5 LORACARBEF KING PHARMS Manufacturing (CMC) Approval
03/08/1993 CLEMASTINE FUMARATE
ANDA #073282		 SUPPL-1 CLEMASTINE FUMARATE ANI PHARMS Manufacturing (CMC) Approval
03/08/1993 CLEMASTINE FUMARATE
ANDA #073283		 SUPPL-1 CLEMASTINE FUMARATE TEVA Manufacturing (CMC) Approval
03/08/1993 CHLORTHALIDONE
ANDA #087176		 SUPPL-14 CHLORTHALIDONE IVAX PHARMS Labeling Approval
03/08/1993 CHLORTHALIDONE
ANDA #088164		 SUPPL-8 CHLORTHALIDONE ANI PHARMS Labeling Approval
03/09/1993 D.H.E. 45
NDA #005929		 SUPPL-18 DIHYDROERGOTAMINE MESYLATE BAUSCH Manufacturing (CMC) Approval
03/09/1993 DROXIA
NDA #016295		 SUPPL-22 HYDROXYUREA CHEPLAPHARM Manufacturing (CMC) Approval
03/09/1993 HYDREA
NDA #016295		 SUPPL-22 HYDROXYUREA CHEPLAPHARM Manufacturing (CMC) Approval
03/09/1993 FUROSEMIDE
NDA #018667		 SUPPL-8 FUROSEMIDE HOSPIRA Labeling Approval
03/09/1993 TRIPHASIL-28
NDA #019190		 SUPPL-24 ETHINYL ESTRADIOL; LEVONORGESTREL WYETH PHARMS INC Manufacturing (CMC) Approval
03/09/1993 TRIPHASIL-21
NDA #019192		 SUPPL-24 ETHINYL ESTRADIOL; LEVONORGESTREL WYETH PHARMS Manufacturing (CMC) Approval
03/09/1993 DIPRIVAN
NDA #019627		 SUPPL-6 PROPOFOL FRESENIUS KABI USA Manufacturing (CMC) Approval
03/09/1993 OPTIRAY 160
NDA #019710		 SUPPL-16 IOVERSOL LIEBEL-FLARSHEIM Efficacy Approval
03/09/1993 OPTIRAY 240
NDA #019710		 SUPPL-16 IOVERSOL LIEBEL-FLARSHEIM Efficacy Approval
03/09/1993 OPTIRAY 300
NDA #019710		 SUPPL-16 IOVERSOL LIEBEL-FLARSHEIM Efficacy Approval
03/09/1993 OPTIRAY 320
NDA #019710		 SUPPL-16 IOVERSOL LIEBEL-FLARSHEIM Efficacy Approval
03/09/1993 OPTIRAY 350
NDA #019710		 SUPPL-16 IOVERSOL LIEBEL-FLARSHEIM Efficacy Approval
03/09/1993 ADAGEN
BLA #019818		 SUPPL-7 PEGADEMASE BOVINE LEADIANT BIOSCI INC Approval
03/09/1993 DESOGEN
NDA #020071		 SUPPL-1 DESOGESTREL; ETHINYL ESTRADIOL ORGANON USA INC Labeling Approval
03/09/1993 PENICILLIN-VK
ANDA #060711		 SUPPL-16 PENICILLIN V POTASSIUM TEVA Labeling Approval
03/09/1993 PENICILLIN-VK
ANDA #060711		 SUPPL-17 PENICILLIN V POTASSIUM TEVA Manufacturing (CMC) Approval
03/09/1993 AMOXIL
ANDA #062226		 SUPPL-14 AMOXICILLIN US ANTIBIOTICS Manufacturing (CMC) Approval
03/09/1993 LAROTID
ANDA #062226		 SUPPL-14 AMOXICILLIN US ANTIBIOTICS Manufacturing (CMC) Approval
03/09/1993 FUROSEMIDE
ANDA #070578		 SUPPL-8 FUROSEMIDE HOSPIRA Labeling Approval
03/09/1993 FUROSEMIDE
ANDA #072080		 SUPPL-4 FUROSEMIDE HOSPIRA Labeling Approval
03/10/1993 ESIDRIX
NDA #011793		 SUPPL-62 HYDROCHLOROTHIAZIDE NOVARTIS Labeling Approval
03/10/1993 SENSORCAINE
NDA #018304		 SUPPL-20 BUPIVACAINE HYDROCHLORIDE FRESENIUS KABI USA Manufacturing (CMC) Approval
03/10/1993 SENSORCAINE
NDA #018304		 SUPPL-20 BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE FRESENIUS KABI USA Manufacturing (CMC) Approval
03/10/1993 PRINIVIL
NDA #019558		 SUPPL-20 LISINOPRIL MERCK Labeling Approval
03/10/1993 PRINZIDE
NDA #019778		 SUPPL-13 HYDROCHLOROTHIAZIDE; LISINOPRIL MERCK Labeling Approval
03/10/1993 ERYTHRA-DERM
ANDA #062687		 SUPPL-3 ERYTHROMYCIN MICRO LABS Labeling Approval
03/10/1993 CEFAZOLIN SODIUM
ANDA #063016		 SUPPL-2 CEFAZOLIN SODIUM TEVA PHARMS Labeling Approval
03/10/1993 TOBRAMYCIN SULFATE
ANDA #063100		 SUPPL-1 TOBRAMYCIN SULFATE TEVA PHARMS USA Manufacturing (CMC) Approval
03/10/1993 SENSORCAINE
ANDA #070552		 SUPPL-7 BUPIVACAINE HYDROCHLORIDE FRESENIUS KABI USA Manufacturing (CMC) Approval
03/10/1993 SENSORCAINE
ANDA #070553		 SUPPL-6 BUPIVACAINE HYDROCHLORIDE FRESENIUS KABI USA Manufacturing (CMC) Approval
03/10/1993 SENSORCAINE
ANDA #070554		 SUPPL-10 BUPIVACAINE HYDROCHLORIDE FRESENIUS KABI USA Manufacturing (CMC) Approval
03/10/1993 SENSORCAINE
ANDA #070966		 SUPPL-8 BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE FRESENIUS KABI USA Manufacturing (CMC) Approval
03/10/1993 SENSORCAINE
ANDA #070967		 SUPPL-7 BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE FRESENIUS KABI USA Manufacturing (CMC) Approval
03/10/1993 SENSORCAINE
ANDA #070968		 SUPPL-7 BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE FRESENIUS KABI USA Manufacturing (CMC) Approval
03/10/1993 ATENOLOL
ANDA #072304		 SUPPL-17 ATENOLOL TWI PHARMS Labeling Approval
03/10/1993 DIPHENHYDRAMINE HYDROCHLORIDE
ANDA #080577		 SUPPL-9 DIPHENHYDRAMINE HYDROCHLORIDE WYETH AYERST Labeling Approval
03/10/1993 DIGOXIN
ANDA #084386		 SUPPL-11 DIGOXIN WYETH AYERST Labeling Approval
03/10/1993 TRIACET
ANDA #084908		 SUPPL-46 TRIAMCINOLONE ACETONIDE TEVA Labeling Approval
03/11/1993 METHERGINE
NDA #006035		 SUPPL-53 METHYLERGONOVINE MALEATE EDISON THERAPS LLC Manufacturing (CMC) Approval
03/11/1993 NATURETIN-10
NDA #012164		 SUPPL-25 BENDROFLUMETHIAZIDE APOTHECON Manufacturing (CMC) Approval
03/11/1993 NATURETIN-2.5
NDA #012164		 SUPPL-25 BENDROFLUMETHIAZIDE APOTHECON Manufacturing (CMC) Approval
03/11/1993 NATURETIN-5
NDA #012164		 SUPPL-25 BENDROFLUMETHIAZIDE APOTHECON Manufacturing (CMC) Approval
03/11/1993 ISOCAINE HYDROCHLORIDE
ANDA #080925		 SUPPL-19 MEPIVACAINE HYDROCHLORIDE SEPTODONT Manufacturing (CMC) Approval
03/11/1993 ISOCAINE HYDROCHLORIDE
ANDA #080925		 SUPPL-21 MEPIVACAINE HYDROCHLORIDE SEPTODONT Manufacturing (CMC) Approval
03/11/1993 AMITRIPTYLINE HYDROCHLORIDE
ANDA #085944		 SUPPL-26 AMITRIPTYLINE HYDROCHLORIDE ROXANE Labeling Approval
03/11/1993 AMITRIPTYLINE HYDROCHLORIDE
ANDA #085945		 SUPPL-25 AMITRIPTYLINE HYDROCHLORIDE ROXANE Labeling Approval
03/11/1993 AMITRIPTYLINE HYDROCHLORIDE
ANDA #086002		 SUPPL-26 AMITRIPTYLINE HYDROCHLORIDE ROXANE Labeling Approval
03/11/1993 AMITRIPTYLINE HYDROCHLORIDE
ANDA #086003		 SUPPL-26 AMITRIPTYLINE HYDROCHLORIDE ROXANE Labeling Approval
03/11/1993 AMITRIPTYLINE HYDROCHLORIDE
ANDA #086004		 SUPPL-25 AMITRIPTYLINE HYDROCHLORIDE ROXANE Labeling Approval
03/11/1993 AMITRIPTYLINE HYDROCHLORIDE
ANDA #086090		 SUPPL-27 AMITRIPTYLINE HYDROCHLORIDE ROXANE Labeling Approval
03/11/1993 DEXAMETHASONE SODIUM PHOSPHATE
ANDA #087440		 SUPPL-15 DEXAMETHASONE SODIUM PHOSPHATE LUITPOLD Manufacturing (CMC) Approval
03/12/1993 ANTIVERT
NDA #010721		 SUPPL-50 MECLIZINE HYDROCHLORIDE CASPER PHARMA LLC Manufacturing (CMC) Approval
03/12/1993 RENAMIN W/O ELECTROLYTES
NDA #017493		 SUPPL-53 AMINO ACIDS BAXTER HLTHCARE Labeling Approval
03/12/1993 RENAMIN W/O ELECTROLYTES
NDA #017493		 SUPPL-56 AMINO ACIDS BAXTER HLTHCARE Labeling Approval
03/12/1993 TRAVASOL 10% W/O ELECTROLYTES
NDA #017493		 SUPPL-53 AMINO ACIDS BAXTER HLTHCARE Labeling Approval
03/12/1993 TRAVASOL 10% W/O ELECTROLYTES
NDA #017493		 SUPPL-56 AMINO ACIDS BAXTER HLTHCARE Labeling Approval
03/12/1993 TRAVASOL 3.5% W/ ELECTROLYTES
NDA #017493		 SUPPL-53 AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE BAXTER HLTHCARE Labeling Approval
03/12/1993 TRAVASOL 3.5% W/ ELECTROLYTES
NDA #017493		 SUPPL-56 AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE BAXTER HLTHCARE Labeling Approval
03/12/1993 TRAVASOL 5.5% W/ ELECTROLYTES
NDA #017493		 SUPPL-53 AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE BAXTER HLTHCARE Labeling Approval
03/12/1993 TRAVASOL 5.5% W/ ELECTROLYTES
NDA #017493		 SUPPL-56 AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE BAXTER HLTHCARE Labeling Approval
03/12/1993 TRAVASOL 5.5% W/O ELECTROLYTES
NDA #017493		 SUPPL-53 AMINO ACIDS BAXTER HLTHCARE Labeling Approval
03/12/1993 TRAVASOL 5.5% W/O ELECTROLYTES
NDA #017493		 SUPPL-56 AMINO ACIDS BAXTER HLTHCARE Labeling Approval
03/12/1993 TRAVASOL 8.5% W/ ELECTROLYTES
NDA #017493		 SUPPL-53 AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE BAXTER HLTHCARE Labeling Approval
03/12/1993 TRAVASOL 8.5% W/ ELECTROLYTES
NDA #017493		 SUPPL-56 AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE BAXTER HLTHCARE Labeling Approval
03/12/1993 TRAVASOL 8.5% W/O ELECTROLYTES
NDA #017493		 SUPPL-53 AMINO ACIDS BAXTER HLTHCARE Labeling Approval
03/12/1993 TRAVASOL 8.5% W/O ELECTROLYTES
NDA #017493		 SUPPL-56 AMINO ACIDS BAXTER HLTHCARE Labeling Approval
03/12/1993 OVCON-50
NDA #017576		 SUPPL-40 ETHINYL ESTRADIOL; NORETHINDRONE WARNER CHILCOTT LLC Labeling Approval
03/12/1993 OVCON-50
NDA #017576		 SUPPL-41 ETHINYL ESTRADIOL; NORETHINDRONE WARNER CHILCOTT LLC Manufacturing (CMC) Approval
03/12/1993 OVCON-35
NDA #017716		 SUPPL-39 ETHINYL ESTRADIOL; NORETHINDRONE WARNER CHILCOTT LLC Labeling Approval
03/12/1993 OVCON-35
NDA #017716		 SUPPL-42 ETHINYL ESTRADIOL; NORETHINDRONE WARNER CHILCOTT LLC Manufacturing (CMC) Approval
03/12/1993 OVCON-35
NDA #018127		 SUPPL-28 ETHINYL ESTRADIOL; NORETHINDRONE WARNER CHILCOTT Labeling Approval
03/12/1993 OVCON-35
NDA #018127		 SUPPL-29 ETHINYL ESTRADIOL; NORETHINDRONE WARNER CHILCOTT Manufacturing (CMC) Approval
03/12/1993 OVCON-50
NDA #018128		 SUPPL-25 ETHINYL ESTRADIOL; NORETHINDRONE WARNER CHILCOTT Labeling Approval
03/12/1993 OVCON-50
NDA #018128		 SUPPL-26 ETHINYL ESTRADIOL; NORETHINDRONE WARNER CHILCOTT Manufacturing (CMC) Approval
03/12/1993 VERSED
NDA #018654		 SUPPL-21 MIDAZOLAM HYDROCHLORIDE HLR Manufacturing (CMC) Approval
03/12/1993 HEXALEN
NDA #019926		 SUPPL-11 ALTRETAMINE EISAI INC Manufacturing (CMC) Approval
03/12/1993 NALBUPHINE HYDROCHLORIDE
NDA #020200		 ORIG-1 NALBUPHINE HYDROCHLORIDE ABBVIE Type 3 - New Dosage Form Approval
03/12/1993 ERYTHROCIN
NDA #050182		 SUPPL-28 ERYTHROMYCIN LACTOBIONATE HOSPIRA Labeling Approval
03/12/1993 ERYTHROCIN
NDA #050609		 SUPPL-9 ERYTHROMYCIN LACTOBIONATE HOSPIRA Labeling Approval
03/12/1993 ERYTHROMYCIN STEARATE
ANDA #061505		 SUPPL-26 ERYTHROMYCIN STEARATE MYLAN Labeling Approval
03/12/1993 DOXYCYCLINE HYCLATE
ANDA #062396		 SUPPL-16 DOXYCYCLINE HYCLATE HIKMA INTL PHARMS Labeling Approval
03/12/1993 CYCLOBENZAPRINE HYDROCHLORIDE
ANDA #071611		 SUPPL-17 CYCLOBENZAPRINE HYDROCHLORIDE ACTAVIS LABS FL INC Manufacturing (CMC) Approval
03/12/1993 CYCLOBENZAPRINE HYDROCHLORIDE
ANDA #071611		 SUPPL-18 CYCLOBENZAPRINE HYDROCHLORIDE ACTAVIS LABS FL INC Labeling Approval
03/12/1993 PIROXICAM
ANDA #073536		 ORIG-1 PIROXICAM SUN PHARM INDUSTRIES Approval
03/12/1993 HYDROCHLOROTHIAZIDE
ANDA #083177		 SUPPL-178 HYDROCHLOROTHIAZIDE IVAX SUB TEVA PHARMS Labeling Approval
03/12/1993 IMIPRAMINE HYDROCHLORIDE
ANDA #084869		 SUPPL-32 IMIPRAMINE HYDROCHLORIDE SANDOZ Labeling Approval
03/12/1993 HYDROCHLOROTHIAZIDE
ANDA #085022		 SUPPL-17 HYDROCHLOROTHIAZIDE IVAX SUB TEVA PHARMS Labeling Approval
03/12/1993 IMIPRAMINE HYDROCHLORIDE
ANDA #085200		 SUPPL-12 IMIPRAMINE HYDROCHLORIDE SANDOZ Labeling Approval
03/15/1993 DIPENTUM
NDA #019715		 SUPPL-3 OLSALAZINE SODIUM MYLAN SPCLT VIATRIS Labeling Approval
03/15/1993 ACETIC ACID
ANDA #088638		 SUPPL-14 ACETIC ACID, GLACIAL TARO Labeling Approval
03/16/1993 SEPTRA
NDA #018452		 SUPPL-20 SULFAMETHOXAZOLE; TRIMETHOPRIM MONARCH PHARMS Manufacturing (CMC) Approval
03/16/1993 LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER
NDA #019830		 SUPPL-1 LIDOCAINE HYDROCHLORIDE B BRAUN Manufacturing (CMC) Approval
03/16/1993 LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER
NDA #019830		 SUPPL-1 LIDOCAINE HYDROCHLORIDE B BRAUN Manufacturing (CMC) Approval
03/16/1993 LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER
NDA #019830		 SUPPL-1 LIDOCAINE HYDROCHLORIDE B BRAUN Manufacturing (CMC) Approval
03/16/1993 MYCOSTATIN
ANDA #060575		 SUPPL-12 NYSTATIN DELCOR ASSET CORP Labeling Approval
03/16/1993 NYSTATIN AND TRIAMCINOLONE ACETONIDE
ANDA #062364		 SUPPL-5 NYSTATIN; TRIAMCINOLONE ACETONIDE TARO Manufacturing (CMC) Approval
03/16/1993 DOXYCYCLINE HYCLATE
ANDA #062538		 SUPPL-9 DOXYCYCLINE HYCLATE STRIDES PHARMA Manufacturing (CMC) Approval
03/17/1993 R-GENE 10
NDA #016931		 SUPPL-25 ARGININE HYDROCHLORIDE PHARMACIA AND UPJOHN Manufacturing (CMC) Approval
03/17/1993 METRO I.V. IN PLASTIC CONTAINER
NDA #018900		 SUPPL-14 METRONIDAZOLE B BRAUN Labeling Approval
03/17/1993 METROGEL-VAGINAL
NDA #020208		 SUPPL-1 METRONIDAZOLE BAUSCH Manufacturing (CMC) Approval
03/17/1993 METHYLDOPA
ANDA #070084		 SUPPL-21 METHYLDOPA ACCORD HLTHCARE Manufacturing (CMC) Approval
03/17/1993 METHYLDOPATE HYDROCHLORIDE
ANDA #070698		 SUPPL-10 METHYLDOPATE HYDROCHLORIDE HOSPIRA Labeling Approval
03/17/1993 VITAMIN A
ANDA #080702		 SUPPL-17 VITAMIN A PALMITATE BANNER PHARMACAPS Labeling Approval
03/17/1993 VITAMIN A PALMITATE
ANDA #083948		 SUPPL-23 VITAMIN A PALMITATE BANNER PHARMACAPS Labeling Approval
03/17/1993 VITAMIN A
ANDA #083973		 SUPPL-27 VITAMIN A BANNER PHARMACAPS Labeling Approval
03/18/1993 TOLECTIN DS
NDA #018084		 SUPPL-44 TOLMETIN SODIUM ORTHO MCNEIL JANSSEN Manufacturing (CMC) Approval
03/18/1993 INTAL
NDA #018596		 SUPPL-13 CROMOLYN SODIUM KING PHARMS LLC Manufacturing (CMC) Approval
03/18/1993 INTAL
NDA #018596		 SUPPL-14 CROMOLYN SODIUM KING PHARMS LLC Manufacturing (CMC) Approval
03/18/1993 ARDUAN
NDA #019638		 SUPPL-2 PIPECURONIUM BROMIDE ORGANON USA INC Manufacturing (CMC) Approval
03/18/1993 ERYGEL
NDA #050617		 SUPPL-2 ERYTHROMYCIN MYLAN Labeling Approval
03/18/1993 GENTAMICIN SULFATE
ANDA #062477		 SUPPL-22 GENTAMICIN SULFATE TARO Labeling Approval
03/18/1993 METOCLOPRAMIDE HYDROCHLORIDE
ANDA #070184		 SUPPL-24 METOCLOPRAMIDE HYDROCHLORIDE TEVA Labeling Approval
03/18/1993 METOCLOPRAMIDE HYDROCHLORIDE
ANDA #070819		 SUPPL-14 METOCLOPRAMIDE HYDROCHLORIDE TEVA Labeling Approval
03/18/1993 PINDOLOL
ANDA #074019		 SUPPL-1 PINDOLOL AUROBINDO PHARMA USA Labeling Approval
03/19/1993 FIORINAL
NDA #017534		 SUPPL-41 ASPIRIN; BUTALBITAL; CAFFEINE ALLERGAN Manufacturing (CMC) Approval
03/19/1993 FIORINAL
NDA #017534		 SUPPL-42 ASPIRIN; BUTALBITAL; CAFFEINE ALLERGAN Manufacturing (CMC) Approval
03/19/1993 LODINE
NDA #018922		 SUPPL-9 ETODOLAC WYETH PHARMS INC Manufacturing (CMC) Approval
03/19/1993 SUFENTA PRESERVATIVE FREE
NDA #019050		 SUPPL-17 SUFENTANIL CITRATE RISING Efficacy Approval
03/19/1993 PRILOSEC
NDA #019810		 SUPPL-13 OMEPRAZOLE ASTRAZENECA Manufacturing (CMC) Approval
03/19/1993 CEFIZOX
NDA #050560		 SUPPL-46 CEFTIZOXIME SODIUM ASTELLAS Labeling Approval
03/19/1993 SANDIMMUNE
NDA #050573		 SUPPL-3 CYCLOSPORINE NOVARTIS Manufacturing (CMC) Approval
03/19/1993 SANDIMMUNE
NDA #050573		 SUPPL-4 CYCLOSPORINE NOVARTIS Manufacturing (CMC) Approval
03/19/1993 SANDIMMUNE
NDA #050573		 SUPPL-7 CYCLOSPORINE NOVARTIS Manufacturing (CMC) Approval
03/19/1993 SANDIMMUNE
NDA #050574		 SUPPL-10 CYCLOSPORINE NOVARTIS Manufacturing (CMC) Approval
03/19/1993 SANDIMMUNE
NDA #050625		 SUPPL-12 CYCLOSPORINE NOVARTIS Manufacturing (CMC) Approval
03/19/1993 METHYLDOPA
ANDA #070075		 SUPPL-20 METHYLDOPA MYLAN Labeling Approval
03/19/1993 METHYLDOPA
ANDA #070076		 SUPPL-19 METHYLDOPA RISING Labeling Approval
03/19/1993 VERAPAMIL HYDROCHLORIDE
ANDA #070468		 SUPPL-24 VERAPAMIL HYDROCHLORIDE ACTAVIS ELIZABETH Manufacturing (CMC) Approval
03/19/1993 VERAPAMIL HYDROCHLORIDE
ANDA #070468		 SUPPL-25 VERAPAMIL HYDROCHLORIDE ACTAVIS ELIZABETH Manufacturing (CMC) Approval
03/19/1993 VERAPAMIL HYDROCHLORIDE
ANDA #071019		 SUPPL-23 VERAPAMIL HYDROCHLORIDE ACTAVIS ELIZABETH Manufacturing (CMC) Approval
03/19/1993 VERAPAMIL HYDROCHLORIDE
ANDA #071019		 SUPPL-24 VERAPAMIL HYDROCHLORIDE ACTAVIS ELIZABETH Manufacturing (CMC) Approval
03/19/1993 LARYNG-O-JET KIT
ANDA #086364		 SUPPL-20 LIDOCAINE HYDROCHLORIDE INTL MEDICATION Manufacturing (CMC) Approval
03/21/1993 RENOVUE-65
NDA #017902		 SUPPL-7 IODAMIDE MEGLUMINE BRACCO Manufacturing (CMC) Approval
03/22/1993 PRAVACHOL
NDA #019898		 SUPPL-3 PRAVASTATIN SODIUM BRISTOL MYERS SQUIBB Labeling Approval
03/22/1993 PRAVACHOL
NDA #019898		 SUPPL-4 PRAVASTATIN SODIUM BRISTOL MYERS SQUIBB Manufacturing (CMC) Approval
03/22/1993 NICORETTE
NDA #020066		 SUPPL-1 NICOTINE POLACRILEX HALEON US HOLDINGS Manufacturing (CMC) Approval
03/22/1993 NICORETTE
NDA #020066		 SUPPL-3 NICOTINE POLACRILEX HALEON US HOLDINGS Manufacturing (CMC) Approval
03/22/1993 NICORETTE (MINT)
NDA #020066		 SUPPL-1 NICOTINE POLACRILEX HALEON US HOLDINGS Manufacturing (CMC) Approval
03/22/1993 NICORETTE (MINT)
NDA #020066		 SUPPL-3 NICOTINE POLACRILEX HALEON US HOLDINGS Manufacturing (CMC) Approval
03/23/1993 DYNACIRC
NDA #019546		 SUPPL-11 ISRADIPINE SMITHKLINE BEECHAM Manufacturing (CMC) Approval
03/23/1993 MOTRIN
NDA #019842		 SUPPL-3 IBUPROFEN MCNEIL CONSUMER Labeling Approval
03/23/1993 CORTISPORIN
NDA #050416		 SUPPL-8 BACITRACIN ZINC; HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE CASPER PHARMA LLC Manufacturing (CMC) Approval
03/23/1993 LUMI-SPORYN
NDA #050417		 SUPPL-6 BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE CASPER PHARMA LLC Manufacturing (CMC) Approval
03/23/1993 CLEOCIN PHOSPHATE
NDA #050441		 SUPPL-37 CLINDAMYCIN PHOSPHATE PFIZER Manufacturing (CMC) Approval
03/23/1993 MANDOL
NDA #050504		 SUPPL-58 CEFAMANDOLE NAFATE LILLY Manufacturing (CMC) Approval
03/23/1993 ERYTHROMYCIN STEARATE
ANDA #061461		 SUPPL-20 ERYTHROMYCIN STEARATE ANI PHARMS Manufacturing (CMC) Approval
03/23/1993 ERYTHROMYCIN STEARATE
ANDA #061461		 SUPPL-21 ERYTHROMYCIN STEARATE ANI PHARMS Manufacturing (CMC) Approval
03/23/1993 CEPHALEXIN
ANDA #061969		 SUPPL-15 CEPHALEXIN IVAX SUB TEVA PHARMS Labeling Approval
03/23/1993 ROCEPHIN
ANDA #062654		 SUPPL-10 CEFTRIAXONE SODIUM HOFFMANN LA ROCHE Labeling Approval
03/23/1993 CLOFIBRATE
ANDA #072600		 SUPPL-2 CLOFIBRATE TEVA Labeling Approval
03/23/1993 LIGNOSPAN FORTE
ANDA #088389		 SUPPL-16 EPINEPHRINE BITARTRATE; LIDOCAINE HYDROCHLORIDE DEPROCO Manufacturing (CMC) Approval
03/23/1993 LIGNOSPAN STANDARD
ANDA #088390		 SUPPL-18 EPINEPHRINE BITARTRATE; LIDOCAINE HYDROCHLORIDE DEPROCO Manufacturing (CMC) Approval
03/24/1993 ALDOMET
NDA #013401		 SUPPL-43 METHYLDOPATE HYDROCHLORIDE MERCK Labeling Approval
03/24/1993 ALDORIL 15
NDA #013402		 SUPPL-75 HYDROCHLOROTHIAZIDE; METHYLDOPA MERCK Labeling Approval
03/24/1993 ALDORIL 25
NDA #013402		 SUPPL-75 HYDROCHLOROTHIAZIDE; METHYLDOPA MERCK Labeling Approval
03/24/1993 ALDORIL D30
NDA #013402		 SUPPL-75 HYDROCHLOROTHIAZIDE; METHYLDOPA MERCK Labeling Approval
03/24/1993 ALDORIL D50
NDA #013402		 SUPPL-75 HYDROCHLOROTHIAZIDE; METHYLDOPA MERCK Labeling Approval
03/24/1993 TECHNETIUM TC-99M MEDRONATE KIT
NDA #018107		 SUPPL-3 TECHNETIUM TC-99M MEDRONATE KIT CARDINAL HEALTH 414 Labeling Approval
03/24/1993 TECHNETIUM TC-99M MEDRONATE KIT
NDA #018107		 SUPPL-6 TECHNETIUM TC-99M MEDRONATE KIT CARDINAL HEALTH 414 Labeling Approval
03/24/1993 SODIUM LACTATE 0.167 MOLAR IN PLASTIC CONTAINER
NDA #018186		 SUPPL-16 SODIUM LACTATE B BRAUN Labeling Approval
03/24/1993 BSS PLUS
NDA #018469		 SUPPL-17 CALCIUM CHLORIDE; DEXTROSE; GLUTATHIONE DISULFIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM PHOSPHATE ALCON Manufacturing (CMC) Approval
03/24/1993 TRAVASOL 10% IN PLASTIC CONTAINER
NDA #018931		 SUPPL-9 AMINO ACIDS BAXTER HLTHCARE Manufacturing (CMC) Approval
03/24/1993 TRAVASOL 5.5% IN PLASTIC CONTAINER
NDA #018931		 SUPPL-9 AMINO ACIDS BAXTER HLTHCARE Manufacturing (CMC) Approval
03/24/1993 TRAVASOL 8.5% IN PLASTIC CONTAINER
NDA #018931		 SUPPL-9 AMINO ACIDS BAXTER HLTHCARE Manufacturing (CMC) Approval
03/24/1993 CHOLETEC
NDA #018963		 SUPPL-2 TECHNETIUM TC-99M MEBROFENIN KIT BRACCO Labeling Approval
03/24/1993 GOLYTELY
NDA #019011		 SUPPL-7 POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUS BRAINTREE Labeling Approval
03/24/1993 GOLYTELY
NDA #019011		 SUPPL-8 POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUS BRAINTREE Labeling Approval
03/24/1993 TICLID
NDA #019979		 SUPPL-7 TICLOPIDINE HYDROCHLORIDE ROCHE PALO Manufacturing (CMC) Approval
03/24/1993 ZOFRAN
NDA #020007		 SUPPL-11 ONDANSETRON HYDROCHLORIDE SANDOZ Manufacturing (CMC) Approval
03/24/1993 ZOFRAN PRESERVATIVE FREE
NDA #020007		 SUPPL-11 ONDANSETRON HYDROCHLORIDE SANDOZ Manufacturing (CMC) Approval
03/24/1993 UNASYN
NDA #050608		 SUPPL-15 AMPICILLIN SODIUM; SULBACTAM SODIUM PFIZER Manufacturing (CMC) Approval
03/24/1993 VELOSEF '125'
ANDA #061763		 SUPPL-17 CEPHRADINE APOTHECON Manufacturing (CMC) Approval
03/24/1993 VELOSEF '125'
ANDA #061763		 SUPPL-18 CEPHRADINE APOTHECON Manufacturing (CMC) Approval
03/24/1993 VELOSEF '125'
ANDA #061763		 SUPPL-19 CEPHRADINE APOTHECON Manufacturing (CMC) Approval
03/24/1993 VELOSEF '250'
ANDA #061763		 SUPPL-17 CEPHRADINE APOTHECON Manufacturing (CMC) Approval
03/24/1993 VELOSEF '250'
ANDA #061763		 SUPPL-18 CEPHRADINE APOTHECON Manufacturing (CMC) Approval
03/24/1993 VELOSEF '250'
ANDA #061763		 SUPPL-19 CEPHRADINE APOTHECON Manufacturing (CMC) Approval
03/24/1993 CLINDAMYCIN PHOSPHATE
ANDA #062944		 SUPPL-1 CLINDAMYCIN PHOSPHATE BOCA PHARMA LLC Labeling Approval
03/24/1993 TRAZODONE HYDROCHLORIDE
ANDA #073137		 ORIG-1 TRAZODONE HYDROCHLORIDE SUN PHARM INDUSTRIES Approval
03/24/1993 PIROXICAM
ANDA #074043		 SUPPL-1 PIROXICAM MYLAN Manufacturing (CMC) Approval
03/24/1993 MEPIVACAINE HYDROCHLORIDE W/ LEVONORDEFRIN
ANDA #084850		 SUPPL-28 LEVONORDEFRIN; MEPIVACAINE HYDROCHLORIDE BELMORA LLC Labeling Approval
03/24/1993 VIRILON
ANDA #087750		 SUPPL-8 METHYLTESTOSTERONE CHARTWELL Labeling Approval
03/25/1993 CISPLATIN
NDA #018057		 SUPPL-60 CISPLATIN HQ SPCLT PHARMA Labeling Approval
03/25/1993 PLATINOL
NDA #018057		 SUPPL-60 CISPLATIN HQ SPCLT PHARMA Labeling Approval
03/25/1993 PLATINOL-AQ
NDA #018057		 SUPPL-60 CISPLATIN HQ SPCLT PHARMA Labeling Approval
03/25/1993 PROZAC
NDA #018936		 SUPPL-32 FLUOXETINE HYDROCHLORIDE ELI LILLY AND CO Labeling Approval
03/25/1993 SARAFEM
NDA #018936		 SUPPL-32 FLUOXETINE HYDROCHLORIDE ELI LILLY AND CO Labeling Approval
03/25/1993 FLORONE E
NDA #019259		 SUPPL-4 DIFLORASONE DIACETATE PFIZER Manufacturing (CMC) Approval
03/25/1993 PSORCON
NDA #019260		 SUPPL-3 DIFLORASONE DIACETATE PFIZER Manufacturing (CMC) Approval
03/25/1993 TIMOPTIC IN OCUDOSE
NDA #019463		 SUPPL-6 TIMOLOL MALEATE BAUSCH AND LOMB INC Manufacturing (CMC) Approval
03/25/1993 PROZAC
NDA #020101		 SUPPL-5 FLUOXETINE HYDROCHLORIDE LILLY Labeling Approval
03/26/1993 ACTHAR GEL
NDA #008372		 SUPPL-30 CORTICOTROPIN MALLINCKRODT ARD Manufacturing (CMC) Approval
03/26/1993 ACTHAR GEL (AUTOINJECTOR)
NDA #008372		 SUPPL-30 CORTICOTROPIN MALLINCKRODT ARD Manufacturing (CMC) Approval
03/26/1993 DIABETA
NDA #017532		 SUPPL-10 GLYBURIDE SANOFI AVENTIS US Manufacturing (CMC) Approval
03/26/1993 DIABETA
NDA #017532		 SUPPL-13 GLYBURIDE SANOFI AVENTIS US Manufacturing (CMC) Approval
03/26/1993 MIACALCIN
NDA #017808		 SUPPL-3 CALCITONIN SALMON MYLAN IRELAND LTD Labeling Approval
03/26/1993 METRONIDAZOLE
NDA #018907		 SUPPL-5 METRONIDAZOLE HIKMA Manufacturing (CMC) Approval
03/26/1993 NOVOLIN R
BLA #019938		 SUPPL-3 INSULIN RECOMBINANT HUMAN NOVO NORDISK INC Approval
03/26/1993 NOVOLIN R
BLA #019938		 SUPPL-5 INSULIN RECOMBINANT HUMAN NOVO NORDISK INC Approval
03/26/1993 NOVOLIN N
BLA #019959		 SUPPL-4 INSULIN SUSP ISOPHANE RECOMBINANT HUMAN NOVO NORDISK INC Approval
03/26/1993 NOVOLIN N
BLA #019959		 SUPPL-6 INSULIN SUSP ISOPHANE RECOMBINANT HUMAN NOVO NORDISK INC Approval
03/26/1993 NOVOLIN 70/30
BLA #019991		 SUPPL-4 INSULIN RECOMBINANT HUMAN; INSULIN SUSP ISOPHANE RECOMBINANT HUMAN NOVO NORDISK INC Approval
03/26/1993 NOVOLIN 70/30
BLA #019991		 SUPPL-6 INSULIN RECOMBINANT HUMAN; INSULIN SUSP ISOPHANE RECOMBINANT HUMAN NOVO NORDISK INC Approval
03/26/1993 NORPLANT SYSTEM IN PLASTIC CONTAINER
NDA #020088		 SUPPL-1 LEVONORGESTREL WYETH PHARMS INC Labeling Approval
03/26/1993 SUPRANE
NDA #020118		 SUPPL-1 DESFLURANE BAXTER HLTHCARE Manufacturing (CMC) Approval
03/26/1993 ZIAC
NDA #020186		 ORIG-1 BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE TEVA BRANDED PHARM Type 4 - New Combination Approval
03/26/1993 DOXYCYCLINE HYCLATE
ANDA #062676		 SUPPL-5 DOXYCYCLINE HYCLATE SUN PHARM INDUSTRIES Labeling Approval
03/26/1993 DOXYCYCLINE HYCLATE
ANDA #062677		 SUPPL-4 DOXYCYCLINE HYCLATE SUN PHARM INDUSTRIES Labeling Approval
03/26/1993 ERYTHROMYCIN LACTOBIONATE
ANDA #062993		 SUPPL-3 ERYTHROMYCIN LACTOBIONATE BAXTER HLTHCARE Labeling Approval
03/26/1993 NALOXONE
ANDA #070298		 SUPPL-9 NALOXONE HYDROCHLORIDE HIKMA Labeling Approval
03/26/1993 NALOXONE
ANDA #070299		 SUPPL-9 NALOXONE HYDROCHLORIDE HIKMA Labeling Approval
03/26/1993 PERPHENAZINE
ANDA #089456		 SUPPL-8 PERPHENAZINE ANI PHARMS Manufacturing (CMC) Approval
03/26/1993 PERPHENAZINE
ANDA #089457		 SUPPL-8 PERPHENAZINE ANI PHARMS Manufacturing (CMC) Approval
03/26/1993 PERPHENAZINE
ANDA #089707		 SUPPL-8 PERPHENAZINE ANI PHARMS Manufacturing (CMC) Approval
03/26/1993 PERPHENAZINE
ANDA #089708		 SUPPL-8 PERPHENAZINE ANI PHARMS Manufacturing (CMC) Approval
03/29/1993 PAVULON
NDA #017015		 SUPPL-16 PANCURONIUM BROMIDE ORGANON USA INC Manufacturing (CMC) Approval
03/29/1993 HEPARIN SODIUM 12,500 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
NDA #019802		 SUPPL-1 HEPARIN SODIUM B BRAUN Manufacturing (CMC) Approval
03/29/1993 HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
NDA #019802		 SUPPL-1 HEPARIN SODIUM B BRAUN Manufacturing (CMC) Approval
03/29/1993 HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #019802		 SUPPL-1 HEPARIN SODIUM B BRAUN Manufacturing (CMC) Approval
03/29/1993 HEPARIN SODIUM 20,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER
NDA #019952		 SUPPL-1 HEPARIN SODIUM B BRAUN Manufacturing (CMC) Approval
03/29/1993 HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER
NDA #019952		 SUPPL-1 HEPARIN SODIUM B BRAUN Manufacturing (CMC) Approval
03/29/1993 HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #019953		 SUPPL-1 HEPARIN SODIUM B BRAUN Manufacturing (CMC) Approval
03/29/1993 HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #019953		 SUPPL-1 HEPARIN SODIUM B BRAUN Manufacturing (CMC) Approval
03/29/1993 LOVENOX
NDA #020164		 ORIG-1 ENOXAPARIN SODIUM SANOFI AVENTIS US Type 1 - New Molecular Entity Approval
03/29/1993 LOVENOX (PRESERVATIVE FREE)
NDA #020164		 ORIG-1 ENOXAPARIN SODIUM SANOFI AVENTIS US Type 1 - New Molecular Entity Approval
03/29/1993 DORYX
NDA #050582		 SUPPL-11 DOXYCYCLINE HYCLATE MAYNE PHARMA Manufacturing (CMC) Approval
03/29/1993 FUNGIZONE
ANDA #060570		 SUPPL-6 AMPHOTERICIN B APOTHECON Labeling Approval
03/29/1993 AMOXICILLIN
ANDA #062853		 SUPPL-4 AMOXICILLIN TEVA Manufacturing (CMC) Approval
03/29/1993 AMOXICILLIN
ANDA #062853		 SUPPL-5 AMOXICILLIN TEVA Manufacturing (CMC) Approval
03/29/1993 AMOXICILLIN
ANDA #062854		 SUPPL-4 AMOXICILLIN TEVA Manufacturing (CMC) Approval
03/29/1993 AMOXICILLIN
ANDA #062854		 SUPPL-5 AMOXICILLIN TEVA Manufacturing (CMC) Approval
03/29/1993 NYSTATIN AND TRIAMCINOLONE ACETONIDE
ANDA #063305		 ORIG-1 NYSTATIN; TRIAMCINOLONE ACETONIDE TARO Approval
03/29/1993 METHYLDOPA
ANDA #070535		 SUPPL-14 METHYLDOPA STRIDES PHARMA Labeling Approval
03/29/1993 METHYLDOPA
ANDA #070536		 SUPPL-17 METHYLDOPA STRIDES PHARMA Labeling Approval
03/29/1993 METHYLDOPA
ANDA #070537		 SUPPL-17 METHYLDOPA STRIDES PHARMA Labeling Approval
03/29/1993 METOCLOPRAMIDE HYDROCHLORIDE
ANDA #071340		 SUPPL-9 METOCLOPRAMIDE HYDROCHLORIDE ACTAVIS MID ATLANTIC Labeling Approval
03/29/1993 LOPERAMIDE HYDROCHLORIDE
ANDA #073079		 SUPPL-1 LOPERAMIDE HYDROCHLORIDE ALLIED Manufacturing (CMC) Approval
03/29/1993 LOPERAMIDE HYDROCHLORIDE
ANDA #073079		 SUPPL-2 LOPERAMIDE HYDROCHLORIDE ALLIED Labeling Approval
03/29/1993 PINDOLOL
ANDA #073609		 ORIG-1 PINDOLOL ANI PHARMS Approval
03/29/1993 PINDOLOL
ANDA #073687		 SUPPL-1 PINDOLOL COSETTE Labeling Approval
03/29/1993 HYDROCHLOROTHIAZIDE
ANDA #085219		 SUPPL-18 HYDROCHLOROTHIAZIDE AUROLIFE PHARMA LLC Labeling Approval
03/29/1993 ACETAMINOPHEN AND CODEINE PHOSPHATE
ANDA #085861		 SUPPL-38 ACETAMINOPHEN; CODEINE PHOSPHATE ACTAVIS MID ATLANTIC Manufacturing (CMC) Approval
03/29/1993 FLUOCINOLONE ACETONIDE
ANDA #087102		 SUPPL-27 FLUOCINOLONE ACETONIDE TARO Labeling Approval
03/29/1993 FLUOCINOLONE ACETONIDE
ANDA #087102		 SUPPL-28 FLUOCINOLONE ACETONIDE TARO Labeling Approval
03/29/1993 FLUOCINOLONE ACETONIDE
ANDA #087104		 SUPPL-28 FLUOCINOLONE ACETONIDE TARO Labeling Approval
03/29/1993 FLUOCINOLONE ACETONIDE
ANDA #089124		 SUPPL-14 FLUOCINOLONE ACETONIDE TARO Labeling Approval
03/29/1993 TRIAMCINOLONE ACETONIDE
ANDA #089129		 SUPPL-11 TRIAMCINOLONE ACETONIDE COSETTE Labeling Approval
03/30/1993 FUROSEMIDE
NDA #018569		 SUPPL-40 FUROSEMIDE EPIC PHARMA LLC Labeling Approval
03/30/1993 CASPORYN HC
NDA #060613		 SUPPL-5 HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE CASPER PHARMA LLC Labeling Approval
03/30/1993 ALBUTEROL SULFATE
ANDA #072652		 SUPPL-2 ALBUTEROL SULFATE MYLAN SPECLT Labeling Approval
03/30/1993 ALBUTEROL SULFATE
ANDA #072652		 SUPPL-3 ALBUTEROL SULFATE MYLAN SPECLT Labeling Approval
03/30/1993 ATENOLOL
ANDA #073475		 ORIG-1 ATENOLOL SUN PHARM INDUSTRIES Approval
03/30/1993 ATENOLOL
ANDA #073476		 ORIG-1 ATENOLOL SUN PHARM INDUSTRIES Approval
03/30/1993 TESTOSTERONE ENANTHATE
ANDA #085598		 SUPPL-34 TESTOSTERONE ENANTHATE WATSON PHARMS INC Labeling Approval
03/31/1993 FLORINEF
NDA #010060		 SUPPL-13 FLUDROCORTISONE ACETATE CASPER PHARMA LLC Labeling Approval
03/31/1993 LOZOL
NDA #018538		 SUPPL-19 INDAPAMIDE SANOFI AVENTIS US Labeling Approval
03/31/1993 MARINOL
NDA #018651		 SUPPL-4 DRONABINOL ALKEM LABS LTD Manufacturing (CMC) Approval
03/31/1993 ZESTRIL
NDA #019777		 SUPPL-18 LISINOPRIL TWI PHARMS Labeling Approval
03/31/1993 ZESTORETIC
NDA #019888		 SUPPL-12 HYDROCHLOROTHIAZIDE; LISINOPRIL ALMATICA Labeling Approval
03/31/1993 NYSTATIN
ANDA #062776		 SUPPL-7 NYSTATIN COSETTE Manufacturing (CMC) Approval
03/31/1993 NYSTATIN
ANDA #062776		 SUPPL-8 NYSTATIN COSETTE Manufacturing (CMC) Approval
03/31/1993 NYSTATIN
ANDA #062776		 SUPPL-10 NYSTATIN COSETTE Manufacturing (CMC) Approval
03/31/1993 DIAZEPAM
ANDA #070706		 SUPPL-5 DIAZEPAM ACTAVIS ELIZABETH Labeling Approval
03/31/1993 DIAZEPAM
ANDA #070707		 SUPPL-8 DIAZEPAM ACTAVIS ELIZABETH Labeling Approval
03/31/1993 DIAZEPAM
ANDA #070781		 SUPPL-4 DIAZEPAM ACTAVIS ELIZABETH Labeling Approval
03/31/1993 LORAZEPAM
ANDA #071141		 SUPPL-12 LORAZEPAM SANDOZ Labeling Approval
03/31/1993 LORAZEPAM
ANDA #071404		 SUPPL-14 LORAZEPAM SANDOZ Labeling Approval
03/31/1993 OXAZEPAM
ANDA #072253		 SUPPL-3 OXAZEPAM ACTAVIS ELIZABETH Labeling Approval
03/31/1993 DILTIAZEM HYDROCHLORIDE
ANDA #074051		 ORIG-1 DILTIAZEM HYDROCHLORIDE APOTHECON Approval
03/31/1993 SULFASALAZINE
ANDA #085828		 SUPPL-28 SULFASALAZINE WATSON LABS Labeling Approval
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