06/01/1979 |
PREDNISONE ANDA #086813 |
ORIG-1 |
PREDNISONE |
WATSON LABS |
|
Approval |
06/04/1979 |
CORTEF NDA #009900 |
SUPPL-16 |
HYDROCORTISONE CYPIONATE |
PHARMACIA AND UPJOHN |
Labeling |
Approval |
06/04/1979 |
KENACORT NDA #011283 |
SUPPL-38 |
TRIAMCINOLONE |
DELCOR ASSET CORP |
Labeling |
Approval |
06/04/1979 |
DESFERAL NDA #016267 |
SUPPL-11 |
DEFEROXAMINE MESYLATE |
NOVARTIS |
Efficacy |
Approval |
06/04/1979 |
DESFERAL NDA #016267 |
SUPPL-12 |
DEFEROXAMINE MESYLATE |
NOVARTIS |
Labeling |
Approval |
06/04/1979 |
RENAMIN W/O ELECTROLYTES NDA #017493 |
SUPPL-23 |
AMINO ACIDS |
BAXTER HLTHCARE |
Manufacturing (CMC) |
Approval |
06/04/1979 |
TRAVASOL 10% W/O ELECTROLYTES NDA #017493 |
SUPPL-23 |
AMINO ACIDS |
BAXTER HLTHCARE |
Manufacturing (CMC) |
Approval |
06/04/1979 |
TRAVASOL 3.5% W/ ELECTROLYTES NDA #017493 |
SUPPL-23 |
AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE |
BAXTER HLTHCARE |
Manufacturing (CMC) |
Approval |
06/04/1979 |
TRAVASOL 5.5% W/ ELECTROLYTES NDA #017493 |
SUPPL-23 |
AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE |
BAXTER HLTHCARE |
Manufacturing (CMC) |
Approval |
06/04/1979 |
TRAVASOL 5.5% W/O ELECTROLYTES NDA #017493 |
SUPPL-23 |
AMINO ACIDS |
BAXTER HLTHCARE |
Manufacturing (CMC) |
Approval |
06/04/1979 |
TRAVASOL 8.5% W/ ELECTROLYTES NDA #017493 |
SUPPL-23 |
AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE |
BAXTER HLTHCARE |
Manufacturing (CMC) |
Approval |
06/04/1979 |
TRAVASOL 8.5% W/O ELECTROLYTES NDA #017493 |
SUPPL-23 |
AMINO ACIDS |
BAXTER HLTHCARE |
Manufacturing (CMC) |
Approval |
06/04/1979 |
OVCON-50 NDA #017576 |
SUPPL-16 |
ETHINYL ESTRADIOL; NORETHINDRONE |
WARNER CHILCOTT LLC |
Labeling |
Approval |
06/04/1979 |
OVCON-35 NDA #017716 |
SUPPL-17 |
ETHINYL ESTRADIOL; NORETHINDRONE |
WARNER CHILCOTT LLC |
Labeling |
Approval |
06/04/1979 |
OVCON-35 NDA #018127 |
SUPPL-3 |
ETHINYL ESTRADIOL; NORETHINDRONE |
WARNER CHILCOTT |
Labeling |
Approval |
06/04/1979 |
OVCON-50 NDA #018128 |
SUPPL-3 |
ETHINYL ESTRADIOL; NORETHINDRONE |
WARNER CHILCOTT |
Labeling |
Approval |
06/05/1979 |
TRANXENE NDA #017105 |
SUPPL-37 |
CLORAZEPATE DIPOTASSIUM |
AJENAT PHARMS |
Manufacturing (CMC) |
Approval |
06/05/1979 |
TRANXENE SD NDA #017105 |
SUPPL-37 |
CLORAZEPATE DIPOTASSIUM |
AJENAT PHARMS |
Manufacturing (CMC) |
Approval |
06/05/1979 |
BUTALBITAL, ASPIRIN AND CAFFEINE ANDA #086162 |
ORIG-1 |
ASPIRIN; BUTALBITAL; CAFFEINE |
HIKMA INTL PHARMS |
|
Approval |
06/06/1979 |
PROVERA NDA #011839 |
SUPPL-35 |
MEDROXYPROGESTERONE ACETATE |
PFIZER |
Efficacy |
Approval |
06/06/1979 |
IVADANTIN NDA #012402 |
SUPPL-15 |
NITROFURANTOIN SODIUM |
PROCTER AND GAMBLE |
Manufacturing (CMC) |
Approval |
06/06/1979 |
IVADANTIN NDA #012402 |
SUPPL-16 |
NITROFURANTOIN SODIUM |
PROCTER AND GAMBLE |
Labeling |
Approval |
06/06/1979 |
DEXEDRINE SPANSULE NDA #017078 |
SUPPL-7 |
DEXTROAMPHETAMINE SULFATE |
IMPAX LABS INC |
Labeling |
Approval |
06/07/1979 |
TRIDIONE NDA #005856 |
SUPPL-8 |
TRIMETHADIONE |
ABBVIE |
Manufacturing (CMC) |
Approval |
06/07/1979 |
TOFRANIL-PM NDA #017090 |
SUPPL-35 |
IMIPRAMINE PAMOATE |
SPECGX LLC |
Manufacturing (CMC) |
Approval |
06/07/1979 |
TOFRANIL-PM NDA #017090 |
SUPPL-36 |
IMIPRAMINE PAMOATE |
SPECGX LLC |
Manufacturing (CMC) |
Approval |
06/07/1979 |
TRANXENE NDA #017105 |
SUPPL-34 |
CLORAZEPATE DIPOTASSIUM |
AJENAT PHARMS |
Manufacturing (CMC) |
Approval |
06/07/1979 |
TRANXENE NDA #017105 |
SUPPL-35 |
CLORAZEPATE DIPOTASSIUM |
AJENAT PHARMS |
Manufacturing (CMC) |
Approval |
06/07/1979 |
TRANXENE NDA #017105 |
SUPPL-36 |
CLORAZEPATE DIPOTASSIUM |
AJENAT PHARMS |
Manufacturing (CMC) |
Approval |
06/07/1979 |
TRANXENE SD NDA #017105 |
SUPPL-34 |
CLORAZEPATE DIPOTASSIUM |
AJENAT PHARMS |
Manufacturing (CMC) |
Approval |
06/07/1979 |
TRANXENE SD NDA #017105 |
SUPPL-35 |
CLORAZEPATE DIPOTASSIUM |
AJENAT PHARMS |
Manufacturing (CMC) |
Approval |
06/07/1979 |
TRANXENE SD NDA #017105 |
SUPPL-36 |
CLORAZEPATE DIPOTASSIUM |
AJENAT PHARMS |
Manufacturing (CMC) |
Approval |
06/07/1979 |
NAPROSYN NDA #017581 |
SUPPL-12 |
NAPROXEN |
ATNAHS PHARMA US |
Manufacturing (CMC) |
Approval |
06/07/1979 |
DEXTROSE 10% IN PLASTIC CONTAINER NDA #018046 |
SUPPL-4 |
DEXTROSE |
B BRAUN |
Manufacturing (CMC) |
Approval |
06/07/1979 |
DEXTROSE 10% IN PLASTIC CONTAINER NDA #018046 |
SUPPL-5 |
DEXTROSE |
B BRAUN |
Labeling |
Approval |
06/08/1979 |
CYSTOGRAFIN NDA #010040 |
SUPPL-100 |
DIATRIZOATE MEGLUMINE |
BRACCO |
Labeling |
Approval |
06/08/1979 |
CYSTOGRAFIN NDA #010040 |
SUPPL-101 |
DIATRIZOATE MEGLUMINE |
BRACCO |
Labeling |
Approval |
06/08/1979 |
CYSTOGRAFIN NDA #010040 |
SUPPL-102 |
DIATRIZOATE MEGLUMINE |
BRACCO |
Labeling |
Approval |
06/08/1979 |
CYSTOGRAFIN DILUTE NDA #010040 |
SUPPL-100 |
DIATRIZOATE MEGLUMINE |
BRACCO |
Labeling |
Approval |
06/08/1979 |
CYSTOGRAFIN DILUTE NDA #010040 |
SUPPL-101 |
DIATRIZOATE MEGLUMINE |
BRACCO |
Labeling |
Approval |
06/08/1979 |
CYSTOGRAFIN DILUTE NDA #010040 |
SUPPL-102 |
DIATRIZOATE MEGLUMINE |
BRACCO |
Labeling |
Approval |
06/08/1979 |
DIATRIZOATE MEGLUMINE NDA #010040 |
SUPPL-100 |
DIATRIZOATE MEGLUMINE |
BRACCO |
Labeling |
Approval |
06/08/1979 |
DIATRIZOATE MEGLUMINE NDA #010040 |
SUPPL-101 |
DIATRIZOATE MEGLUMINE |
BRACCO |
Labeling |
Approval |
06/08/1979 |
DIATRIZOATE MEGLUMINE NDA #010040 |
SUPPL-102 |
DIATRIZOATE MEGLUMINE |
BRACCO |
Labeling |
Approval |
06/08/1979 |
RENO-30 NDA #010040 |
SUPPL-100 |
DIATRIZOATE MEGLUMINE |
BRACCO |
Labeling |
Approval |
06/08/1979 |
RENO-30 NDA #010040 |
SUPPL-101 |
DIATRIZOATE MEGLUMINE |
BRACCO |
Labeling |
Approval |
06/08/1979 |
RENO-30 NDA #010040 |
SUPPL-102 |
DIATRIZOATE MEGLUMINE |
BRACCO |
Labeling |
Approval |
06/08/1979 |
RENO-60 NDA #010040 |
SUPPL-100 |
DIATRIZOATE MEGLUMINE |
BRACCO |
Labeling |
Approval |
06/08/1979 |
RENO-60 NDA #010040 |
SUPPL-101 |
DIATRIZOATE MEGLUMINE |
BRACCO |
Labeling |
Approval |
06/08/1979 |
RENO-60 NDA #010040 |
SUPPL-102 |
DIATRIZOATE MEGLUMINE |
BRACCO |
Labeling |
Approval |
06/08/1979 |
RENO-DIP NDA #010040 |
SUPPL-100 |
DIATRIZOATE MEGLUMINE |
BRACCO |
Labeling |
Approval |
06/08/1979 |
RENO-DIP NDA #010040 |
SUPPL-101 |
DIATRIZOATE MEGLUMINE |
BRACCO |
Labeling |
Approval |
06/08/1979 |
RENO-DIP NDA #010040 |
SUPPL-102 |
DIATRIZOATE MEGLUMINE |
BRACCO |
Labeling |
Approval |
06/08/1979 |
RENOGRAFIN-60 NDA #010040 |
SUPPL-100 |
DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM |
BRACCO |
Labeling |
Approval |
06/08/1979 |
RENOGRAFIN-60 NDA #010040 |
SUPPL-101 |
DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM |
BRACCO |
Labeling |
Approval |
06/08/1979 |
RENOGRAFIN-60 NDA #010040 |
SUPPL-102 |
DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM |
BRACCO |
Labeling |
Approval |
06/08/1979 |
RENOGRAFIN-76 NDA #010040 |
SUPPL-100 |
DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM |
BRACCO |
Labeling |
Approval |
06/08/1979 |
RENOGRAFIN-76 NDA #010040 |
SUPPL-101 |
DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM |
BRACCO |
Labeling |
Approval |
06/08/1979 |
RENOGRAFIN-76 NDA #010040 |
SUPPL-102 |
DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM |
BRACCO |
Labeling |
Approval |
06/08/1979 |
RENOVIST NDA #010040 |
SUPPL-100 |
DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM |
BRACCO |
Labeling |
Approval |
06/08/1979 |
RENOVIST NDA #010040 |
SUPPL-101 |
DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM |
BRACCO |
Labeling |
Approval |
06/08/1979 |
RENOVIST NDA #010040 |
SUPPL-102 |
DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM |
BRACCO |
Labeling |
Approval |
06/08/1979 |
RENOVIST II NDA #010040 |
SUPPL-100 |
DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM |
BRACCO |
Labeling |
Approval |
06/08/1979 |
RENOVIST II NDA #010040 |
SUPPL-101 |
DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM |
BRACCO |
Labeling |
Approval |
06/08/1979 |
RENOVIST II NDA #010040 |
SUPPL-102 |
DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM |
BRACCO |
Labeling |
Approval |
06/08/1979 |
HEXADROL NDA #012675 |
SUPPL-8 |
DEXAMETHASONE |
ASPEN GLOBAL INC |
Manufacturing (CMC) |
Approval |
06/08/1979 |
DEXTROSE 5% IN PLASTIC CONTAINER NDA #016730 |
SUPPL-11 |
DEXTROSE |
B BRAUN |
Manufacturing (CMC) |
Approval |
06/08/1979 |
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER NDA #017464 |
SUPPL-5 |
SODIUM CHLORIDE |
B BRAUN |
Manufacturing (CMC) |
Approval |
06/08/1979 |
DEXTROSE 5% IN LACTATED RINGER'S IN PLASTIC CONTAINER NDA #017510 |
SUPPL-6 |
CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE |
B BRAUN |
Manufacturing (CMC) |
Approval |
06/08/1979 |
LACTATED RINGER'S IN PLASTIC CONTAINER NDA #018023 |
SUPPL-6 |
CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE |
B BRAUN |
Manufacturing (CMC) |
Approval |
06/08/1979 |
DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER NDA #018026 |
SUPPL-5 |
DEXTROSE; SODIUM CHLORIDE |
B BRAUN |
Manufacturing (CMC) |
Approval |
06/08/1979 |
DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER NDA #018030 |
SUPPL-5 |
DEXTROSE; SODIUM CHLORIDE |
B BRAUN |
Manufacturing (CMC) |
Approval |
06/08/1979 |
DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER NDA #018030 |
SUPPL-5 |
DEXTROSE; SODIUM CHLORIDE |
B BRAUN |
Manufacturing (CMC) |
Approval |
06/08/1979 |
DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER NDA #018030 |
SUPPL-5 |
DEXTROSE; SODIUM CHLORIDE |
B BRAUN |
Manufacturing (CMC) |
Approval |
06/08/1979 |
DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER NDA #018030 |
SUPPL-5 |
DEXTROSE; SODIUM CHLORIDE |
B BRAUN |
Manufacturing (CMC) |
Approval |
06/08/1979 |
DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER NDA #018030 |
SUPPL-5 |
DEXTROSE; SODIUM CHLORIDE |
B BRAUN |
Manufacturing (CMC) |
Approval |
06/08/1979 |
DEXTROSE 10% IN PLASTIC CONTAINER NDA #018046 |
SUPPL-6 |
DEXTROSE |
B BRAUN |
Manufacturing (CMC) |
Approval |
06/08/1979 |
DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER NDA #018047 |
SUPPL-4 |
DEXTROSE; SODIUM CHLORIDE |
B BRAUN |
Manufacturing (CMC) |
Approval |
06/08/1979 |
SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER NDA #018184 |
ORIG-1 |
SODIUM CHLORIDE |
B BRAUN |
|
Approval |
06/11/1979 |
INTROPIN NDA #017395 |
SUPPL-8 |
DOPAMINE HYDROCHLORIDE |
HOSPIRA |
Labeling |
Approval |
06/11/1979 |
INTROPIN NDA #017395 |
SUPPL-9 |
DOPAMINE HYDROCHLORIDE |
HOSPIRA |
Labeling |
Approval |
06/11/1979 |
INTROPIN NDA #017395 |
SUPPL-10 |
DOPAMINE HYDROCHLORIDE |
HOSPIRA |
Labeling |
Approval |
06/11/1979 |
NEBCIN NDA #050519 |
ORIG-1 |
TOBRAMYCIN SULFATE |
LILLY |
Type 3 - New Dosage Form |
Approval |
06/12/1979 |
SURMONTIL NDA #016792 |
ORIG-1 |
TRIMIPRAMINE MALEATE |
ODYSSEY PHARMS |
Type 1 - New Molecular Entity |
Approval |
06/12/1979 |
CARISOPRODOL ANDA #086179 |
ORIG-1 |
CARISOPRODOL |
WATSON LABS TEVA |
|
Approval |
06/13/1979 |
NESACAINE NDA #009435 |
SUPPL-10 |
CHLOROPROCAINE HYDROCHLORIDE |
FRESENIUS KABI USA |
Manufacturing (CMC) |
Approval |
06/13/1979 |
NESACAINE-MPF NDA #009435 |
SUPPL-10 |
CHLOROPROCAINE HYDROCHLORIDE |
FRESENIUS KABI USA |
Manufacturing (CMC) |
Approval |
06/14/1979 |
MESANTOIN NDA #006008 |
SUPPL-25 |
MEPHENYTOIN |
NOVARTIS |
Manufacturing (CMC) |
Approval |
06/14/1979 |
ISONIAZID NDA #008428 |
SUPPL-22 |
ISONIAZID |
PANRAY |
Manufacturing (CMC) |
Approval |
06/14/1979 |
HYDERGINE NDA #009087 |
SUPPL-25 |
ERGOLOID MESYLATES |
NOVARTIS |
Manufacturing (CMC) |
Approval |
06/14/1979 |
KEMADRIN NDA #009818 |
SUPPL-11 |
PROCYCLIDINE HYDROCHLORIDE |
MONARCH PHARMS |
Manufacturing (CMC) |
Approval |
06/14/1979 |
PLASMA-LYTE 148 IN WATER IN PLASTIC CONTAINER NDA #017378 |
SUPPL-2 |
MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE |
BAXTER HLTHCARE |
Manufacturing (CMC) |
Approval |
06/14/1979 |
PLASMA-LYTE A IN PLASTIC CONTAINER NDA #017378 |
SUPPL-2 |
MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE |
BAXTER HLTHCARE |
Manufacturing (CMC) |
Approval |
06/14/1979 |
SILVADENE NDA #017381 |
SUPPL-15 |
SILVER SULFADIAZINE |
KING PHARMS LLC |
Labeling |
Approval |
06/14/1979 |
MONISTAT 7 NDA #017450 |
SUPPL-13 |
MICONAZOLE NITRATE |
MEDTECH PRODUCTS |
Manufacturing (CMC) |
Approval |
06/14/1979 |
MONISTAT 7 NDA #017450 |
SUPPL-14 |
MICONAZOLE NITRATE |
MEDTECH PRODUCTS |
Manufacturing (CMC) |
Approval |
06/14/1979 |
PLASMA-LYTE 148 AND DEXTROSE 5% IN PLASTIC CONTAINER NDA #017451 |
SUPPL-2 |
DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE |
BAXTER HLTHCARE |
Manufacturing (CMC) |
Approval |
06/14/1979 |
DEXTROSE 5% AND ELECTROLYTE NO. 48 IN PLASTIC CONTAINER NDA #017484 |
SUPPL-2 |
DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, MONOBASIC; SODIUM CHLORIDE; SODIUM LACTATE |
BAXTER HLTHCARE |
Manufacturing (CMC) |
Approval |
06/14/1979 |
VANCERIL NDA #017573 |
SUPPL-2 |
BECLOMETHASONE DIPROPIONATE |
SCHERING |
Labeling |
Approval |
06/14/1979 |
VANCERIL NDA #017573 |
SUPPL-5 |
BECLOMETHASONE DIPROPIONATE |
SCHERING |
Labeling |
Approval |
06/14/1979 |
POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.45% NDA #017648 |
SUPPL-2 |
POTASSIUM CHLORIDE; SODIUM CHLORIDE |
BAXTER HLTHCARE |
Manufacturing (CMC) |
Approval |
06/14/1979 |
POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.9% NDA #017648 |
SUPPL-2 |
POTASSIUM CHLORIDE; SODIUM CHLORIDE |
BAXTER HLTHCARE |
Manufacturing (CMC) |
Approval |
06/14/1979 |
POTASSIUM CHLORIDE 0.224% IN SODIUM CHLORIDE 0.9% NDA #017648 |
SUPPL-2 |
POTASSIUM CHLORIDE; SODIUM CHLORIDE |
BAXTER HLTHCARE |
Manufacturing (CMC) |
Approval |
06/14/1979 |
POTASSIUM CHLORIDE 0.3% AND SODIUM CHLORIDE 0.9% NDA #017648 |
SUPPL-2 |
POTASSIUM CHLORIDE; SODIUM CHLORIDE |
BAXTER HLTHCARE |
Manufacturing (CMC) |
Approval |
06/14/1979 |
SODIUM CHLORIDE 0.9% AND POTASSIUM CHLORIDE 0.075% NDA #017648 |
SUPPL-2 |
POTASSIUM CHLORIDE; SODIUM CHLORIDE |
BAXTER HLTHCARE |
Manufacturing (CMC) |
Approval |
06/14/1979 |
MELLARIL-S NDA #017923 |
SUPPL-4 |
THIORIDAZINE |
NOVARTIS |
Manufacturing (CMC) |
Approval |
06/14/1979 |
DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 15MEQ IN PLASTIC CONTAINER NDA #018008 |
SUPPL-2 |
DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE |
BAXTER HLTHCARE |
Manufacturing (CMC) |
Approval |
06/14/1979 |
DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 20MEQ (K) IN PLASTIC CONTAINER NDA #018008 |
SUPPL-2 |
DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE |
BAXTER HLTHCARE |
Manufacturing (CMC) |
Approval |
06/14/1979 |
DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 5MEQ IN PLASTIC CONTAINER NDA #018008 |
SUPPL-2 |
DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE |
BAXTER HLTHCARE |
Manufacturing (CMC) |
Approval |
06/14/1979 |
POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER NDA #018008 |
SUPPL-2 |
DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE |
BAXTER HLTHCARE |
Manufacturing (CMC) |
Approval |
06/14/1979 |
POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER NDA #018008 |
SUPPL-2 |
DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE |
BAXTER HLTHCARE |
Manufacturing (CMC) |
Approval |
06/14/1979 |
POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER NDA #018008 |
SUPPL-2 |
DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE |
BAXTER HLTHCARE |
Manufacturing (CMC) |
Approval |
06/14/1979 |
POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER NDA #018008 |
SUPPL-2 |
DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE |
BAXTER HLTHCARE |
Manufacturing (CMC) |
Approval |
06/14/1979 |
POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER NDA #018008 |
SUPPL-2 |
DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE |
BAXTER HLTHCARE |
Manufacturing (CMC) |
Approval |
06/14/1979 |
PAMELOR NDA #018013 |
SUPPL-3 |
NORTRIPTYLINE HYDROCHLORIDE |
SPECGX LLC |
Manufacturing (CMC) |
Approval |
06/14/1979 |
SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER NDA #018016 |
SUPPL-2 |
SODIUM CHLORIDE |
BAXTER HLTHCARE |
Manufacturing (CMC) |
Approval |
06/14/1979 |
DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 10MEQ NDA #018037 |
SUPPL-2 |
DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE |
BAXTER HLTHCARE |
Manufacturing (CMC) |
Approval |
06/14/1979 |
DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 15MEQ (K) NDA #018037 |
SUPPL-2 |
DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE |
BAXTER HLTHCARE |
Manufacturing (CMC) |
Approval |
06/14/1979 |
DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 20MEQ NDA #018037 |
SUPPL-2 |
DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE |
BAXTER HLTHCARE |
Manufacturing (CMC) |
Approval |
06/14/1979 |
DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 20MEQ (K) NDA #018037 |
SUPPL-2 |
DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE |
BAXTER HLTHCARE |
Manufacturing (CMC) |
Approval |
06/14/1979 |
DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 30MEQ NDA #018037 |
SUPPL-2 |
DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE |
BAXTER HLTHCARE |
Manufacturing (CMC) |
Approval |
06/14/1979 |
DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 40MEQ NDA #018037 |
SUPPL-2 |
DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE |
BAXTER HLTHCARE |
Manufacturing (CMC) |
Approval |
06/14/1979 |
DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 5MEQ NDA #018037 |
SUPPL-2 |
DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE |
BAXTER HLTHCARE |
Manufacturing (CMC) |
Approval |
06/14/1979 |
DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 5MEQ (K) NDA #018037 |
SUPPL-2 |
DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE |
BAXTER HLTHCARE |
Manufacturing (CMC) |
Approval |
06/14/1979 |
ERYTHROMYCIN ESTOLATE ANDA #062087 |
ORIG-1 |
ERYTHROMYCIN ESTOLATE |
WATSON LABS |
|
Approval |
06/15/1979 |
VANCERIL NDA #017573 |
SUPPL-7 |
BECLOMETHASONE DIPROPIONATE |
SCHERING |
Manufacturing (CMC) |
Approval |
06/15/1979 |
PAMELOR NDA #018012 |
SUPPL-3 |
NORTRIPTYLINE HYDROCHLORIDE |
SPECGX LLC |
Manufacturing (CMC) |
Approval |
06/15/1979 |
INDERIDE-40/25 NDA #018031 |
ORIG-1 |
HYDROCHLOROTHIAZIDE; PROPRANOLOL HYDROCHLORIDE |
WYETH PHARMS INC |
Type 4 - New Combination |
Approval |
06/15/1979 |
INDERIDE-80/25 NDA #018031 |
ORIG-1 |
HYDROCHLOROTHIAZIDE; PROPRANOLOL HYDROCHLORIDE |
WYETH PHARMS INC |
Type 4 - New Combination |
Approval |
06/15/1979 |
SODIUM LACTATE 0.167 MOLAR IN PLASTIC CONTAINER NDA #018186 |
ORIG-1 |
SODIUM LACTATE |
B BRAUN |
|
Approval |
06/18/1979 |
CORTRIL NDA #009176 |
SUPPL-5 |
HYDROCORTISONE |
PFIZER GLOBAL |
Labeling |
Approval |
06/18/1979 |
SOLU-CORTEF NDA #009866 |
SUPPL-43 |
HYDROCORTISONE SODIUM SUCCINATE |
PHARMACIA AND UPJOHN |
Manufacturing (CMC) |
Approval |
06/18/1979 |
MUCOMYST NDA #013601 |
SUPPL-33 |
ACETYLCYSTEINE |
APOTHECON |
Manufacturing (CMC) |
Approval |
06/18/1979 |
ALDOCLOR-150 NDA #016016 |
SUPPL-35 |
CHLOROTHIAZIDE; METHYLDOPA |
MERCK |
Manufacturing (CMC) |
Approval |
06/18/1979 |
ALDOCLOR-150 NDA #016016 |
SUPPL-36 |
CHLOROTHIAZIDE; METHYLDOPA |
MERCK |
Manufacturing (CMC) |
Approval |
06/18/1979 |
ALDOCLOR-250 NDA #016016 |
SUPPL-35 |
CHLOROTHIAZIDE; METHYLDOPA |
MERCK |
Manufacturing (CMC) |
Approval |
06/18/1979 |
ALDOCLOR-250 NDA #016016 |
SUPPL-36 |
CHLOROTHIAZIDE; METHYLDOPA |
MERCK |
Manufacturing (CMC) |
Approval |
06/18/1979 |
MARCAINE HYDROCHLORIDE NDA #016964 |
SUPPL-17 |
BUPIVACAINE HYDROCHLORIDE |
HOSPIRA |
Labeling |
Approval |
06/18/1979 |
MARCAINE HYDROCHLORIDE PRESERVATIVE FREE NDA #016964 |
SUPPL-17 |
BUPIVACAINE HYDROCHLORIDE |
HOSPIRA |
Labeling |
Approval |
06/18/1979 |
MARCAINE HYDROCHLORIDE W/ EPINEPHRINE NDA #016964 |
SUPPL-17 |
BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE |
HOSPIRA |
Labeling |
Approval |
06/18/1979 |
MARCAINE HYDROCHLORIDE W/ EPINEPHRINE PRESERVATIVE FREE NDA #016964 |
SUPPL-17 |
BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE |
HOSPIRA |
Labeling |
Approval |
06/18/1979 |
GLYCINE 1.5% IN PLASTIC CONTAINER NDA #017633 |
SUPPL-12 |
GLYCINE |
HOSPIRA |
Manufacturing (CMC) |
Approval |
06/19/1979 |
CYTOXAN NDA #012142 |
SUPPL-43 |
CYCLOPHOSPHAMIDE |
BAXTER HLTHCARE |
Manufacturing (CMC) |
Approval |
06/19/1979 |
CYTOXAN (LYOPHILIZED) NDA #012142 |
SUPPL-43 |
CYCLOPHOSPHAMIDE |
BAXTER HLTHCARE |
Manufacturing (CMC) |
Approval |
06/19/1979 |
LYOPHILIZED CYTOXAN NDA #012142 |
SUPPL-43 |
CYCLOPHOSPHAMIDE |
BAXTER HLTHCARE |
Manufacturing (CMC) |
Approval |
06/19/1979 |
GLYCINE 1.5% IN PLASTIC CONTAINER NDA #016784 |
SUPPL-3 |
GLYCINE |
B BRAUN |
Labeling |
Approval |
06/19/1979 |
MODICON 21 NDA #017488 |
SUPPL-45 |
ETHINYL ESTRADIOL; NORETHINDRONE |
ORTHO MCNEIL PHARM |
Manufacturing (CMC) |
Approval |
06/19/1979 |
ORTHO-NOVUM 1/35-21 NDA #017489 |
SUPPL-40 |
ETHINYL ESTRADIOL; NORETHINDRONE |
ORTHO MCNEIL PHARM |
Manufacturing (CMC) |
Approval |
06/19/1979 |
MODICON 28 NDA #017735 |
SUPPL-23 |
ETHINYL ESTRADIOL; NORETHINDRONE |
JANSSEN PHARMS |
Manufacturing (CMC) |
Approval |
06/19/1979 |
ORTHO-NOVUM 1/35-28 NDA #017919 |
SUPPL-10 |
ETHINYL ESTRADIOL; NORETHINDRONE |
JANSSEN PHARMS |
Manufacturing (CMC) |
Approval |
06/19/1979 |
ERYTHROCIN NDA #050182 |
SUPPL-67 |
ERYTHROMYCIN LACTOBIONATE |
HOSPIRA |
Manufacturing (CMC) |
Approval |
06/20/1979 |
PERIACTIN NDA #012649 |
SUPPL-27 |
CYPROHEPTADINE HYDROCHLORIDE |
MERCK |
Labeling |
Approval |
06/20/1979 |
MEGACE NDA #016979 |
SUPPL-15 |
MEGESTROL ACETATE |
BRISTOL MYERS SQUIBB |
Manufacturing (CMC) |
Approval |
06/20/1979 |
MOTRIN NDA #017463 |
SUPPL-42 |
IBUPROFEN |
MCNEIL CONSUMER |
Manufacturing (CMC) |
Approval |
06/20/1979 |
DIPROSONE NDA #017691 |
SUPPL-5 |
BETAMETHASONE DIPROPIONATE |
SCHERING |
Manufacturing (CMC) |
Approval |
06/20/1979 |
CHRONULAC NDA #017884 |
ORIG-1 |
LACTULOSE |
SANOFI AVENTIS US |
Type 5 - New Formulation or New Manufacturer |
Approval |
06/20/1979 |
ERYTHROCIN NDA #050182 |
SUPPL-68 |
ERYTHROMYCIN LACTOBIONATE |
HOSPIRA |
Manufacturing (CMC) |
Approval |
06/20/1979 |
LINCOCIN NDA #050316 |
SUPPL-87 |
LINCOMYCIN HYDROCHLORIDE |
PHARMACIA AND UPJOHN |
Manufacturing (CMC) |
Approval |
06/20/1979 |
LINCOCIN NDA #050317 |
SUPPL-148 |
LINCOMYCIN HYDROCHLORIDE |
PFIZER |
Labeling |
Approval |
06/21/1979 |
DIENESTROL NDA #006110 |
SUPPL-15 |
DIENESTROL |
ORTHO MCNEIL PHARM |
Efficacy |
Approval |
06/21/1979 |
QUINIDEX NDA #012796 |
SUPPL-18 |
QUINIDINE SULFATE |
WYETH PHARMS INC |
Labeling |
Approval |
06/21/1979 |
EDECRIN NDA #016092 |
SUPPL-15 |
ETHACRYNIC ACID |
BAUSCH |
Manufacturing (CMC) |
Approval |
06/21/1979 |
EDECRIN NDA #016093 |
SUPPL-15 |
ETHACRYNATE SODIUM |
BAUSCH |
Manufacturing (CMC) |
Approval |
06/21/1979 |
MICRONOR NDA #016954 |
SUPPL-39 |
NORETHINDRONE |
JANSSEN PHARMS |
REMS |
Approval |
06/25/1979 |
LEVO-DROMORAN NDA #008720 |
SUPPL-9 |
LEVORPHANOL TARTRATE |
VALEANT PHARM INTL |
Manufacturing (CMC) |
Approval |
06/25/1979 |
MEDIHALER ERGOTAMINE NDA #012102 |
SUPPL-5 |
ERGOTAMINE TARTRATE |
3M |
Labeling |
Approval |
06/25/1979 |
ISMELIN NDA #012329 |
SUPPL-42 |
GUANETHIDINE MONOSULFATE |
NOVARTIS |
Manufacturing (CMC) |
Approval |
06/25/1979 |
ISMELIN NDA #012329 |
SUPPL-43 |
GUANETHIDINE MONOSULFATE |
NOVARTIS |
Manufacturing (CMC) |
Approval |
06/25/1979 |
ISMELIN NDA #012329 |
SUPPL-44 |
GUANETHIDINE MONOSULFATE |
NOVARTIS |
Manufacturing (CMC) |
Approval |
06/25/1979 |
LASIX NDA #016363 |
SUPPL-28 |
FUROSEMIDE |
SANOFI AVENTIS US |
Manufacturing (CMC) |
Approval |
06/25/1979 |
ALUPENT NDA #017571 |
SUPPL-10 |
METAPROTERENOL SULFATE |
BOEHRINGER INGELHEIM |
Manufacturing (CMC) |
Approval |
06/25/1979 |
DITROPAN NDA #017577 |
SUPPL-8 |
OXYBUTYNIN CHLORIDE |
JANSSEN PHARMS |
Labeling |
Approval |
06/25/1979 |
IMODIUM NDA #017694 |
SUPPL-11 |
LOPERAMIDE HYDROCHLORIDE |
J AND J CONSUMER INC |
Labeling |
Approval |
06/26/1979 |
SYNCURINE NDA #006931 |
SUPPL-3 |
DECAMETHONIUM BROMIDE |
GLAXOSMITHKLINE |
Manufacturing (CMC) |
Approval |
06/26/1979 |
ACTHAR NDA #007504 |
SUPPL-15 |
CORTICOTROPIN |
SANOFI AVENTIS US |
Labeling |
Approval |
06/26/1979 |
ACTHAR NDA #007504 |
SUPPL-16 |
CORTICOTROPIN |
SANOFI AVENTIS US |
Labeling |
Approval |
06/26/1979 |
ACTHAR GEL NDA #008372 |
SUPPL-18 |
CORTICOTROPIN |
MALLINCKRODT ARD |
Labeling |
Approval |
06/26/1979 |
ACTHAR GEL NDA #008372 |
SUPPL-20 |
CORTICOTROPIN |
MALLINCKRODT ARD |
Labeling |
Approval |
06/26/1979 |
ACTHAR GEL NDA #008372 |
SUPPL-21 |
CORTICOTROPIN |
MALLINCKRODT ARD |
Labeling |
Approval |
06/26/1979 |
ACTHAR GEL NDA #008372 |
SUPPL-22 |
CORTICOTROPIN |
MALLINCKRODT ARD |
Manufacturing (CMC) |
Approval |
06/26/1979 |
ACTHAR GEL (AUTOINJECTOR) NDA #008372 |
SUPPL-18 |
CORTICOTROPIN |
MALLINCKRODT ARD |
Labeling |
Approval |
06/26/1979 |
ACTHAR GEL (AUTOINJECTOR) NDA #008372 |
SUPPL-20 |
CORTICOTROPIN |
MALLINCKRODT ARD |
Labeling |
Approval |
06/26/1979 |
ACTHAR GEL (AUTOINJECTOR) NDA #008372 |
SUPPL-21 |
CORTICOTROPIN |
MALLINCKRODT ARD |
Labeling |
Approval |
06/26/1979 |
ACTHAR GEL (AUTOINJECTOR) NDA #008372 |
SUPPL-22 |
CORTICOTROPIN |
MALLINCKRODT ARD |
Manufacturing (CMC) |
Approval |
06/26/1979 |
CYSTOGRAFIN NDA #010040 |
SUPPL-93 |
DIATRIZOATE MEGLUMINE |
BRACCO |
Labeling |
Approval |
06/26/1979 |
CYSTOGRAFIN DILUTE NDA #010040 |
SUPPL-93 |
DIATRIZOATE MEGLUMINE |
BRACCO |
Labeling |
Approval |
06/26/1979 |
DIATRIZOATE MEGLUMINE NDA #010040 |
SUPPL-93 |
DIATRIZOATE MEGLUMINE |
BRACCO |
Labeling |
Approval |
06/26/1979 |
RENO-30 NDA #010040 |
SUPPL-93 |
DIATRIZOATE MEGLUMINE |
BRACCO |
Labeling |
Approval |
06/26/1979 |
RENO-60 NDA #010040 |
SUPPL-93 |
DIATRIZOATE MEGLUMINE |
BRACCO |
Labeling |
Approval |
06/26/1979 |
RENO-DIP NDA #010040 |
SUPPL-93 |
DIATRIZOATE MEGLUMINE |
BRACCO |
Labeling |
Approval |
06/26/1979 |
RENOGRAFIN-60 NDA #010040 |
SUPPL-93 |
DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM |
BRACCO |
Labeling |
Approval |
06/26/1979 |
RENOGRAFIN-76 NDA #010040 |
SUPPL-93 |
DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM |
BRACCO |
Labeling |
Approval |
06/26/1979 |
RENOVIST NDA #010040 |
SUPPL-93 |
DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM |
BRACCO |
Labeling |
Approval |
06/26/1979 |
RENOVIST II NDA #010040 |
SUPPL-93 |
DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM |
BRACCO |
Labeling |
Approval |
06/26/1979 |
SINOGRAFIN NDA #011324 |
SUPPL-20 |
DIATRIZOATE MEGLUMINE; IODIPAMIDE MEGLUMINE |
BRACCO |
Labeling |
Approval |
06/26/1979 |
DIMETANE-TEN NDA #011418 |
SUPPL-14 |
BROMPHENIRAMINE MALEATE |
WYETH AYERST |
Manufacturing (CMC) |
Approval |
06/26/1979 |
DIMETANE-TEN NDA #011418 |
SUPPL-15 |
BROMPHENIRAMINE MALEATE |
WYETH AYERST |
Labeling |
Approval |
06/26/1979 |
CARBOCAINE NDA #012250 |
SUPPL-12 |
MEPIVACAINE HYDROCHLORIDE |
HOSPIRA |
Labeling |
Approval |
06/26/1979 |
ALUPENT NDA #015874 |
SUPPL-20 |
METAPROTERENOL SULFATE |
BOEHRINGER INGELHEIM |
Manufacturing (CMC) |
Approval |
06/26/1979 |
VANCERIL NDA #017573 |
SUPPL-6 |
BECLOMETHASONE DIPROPIONATE |
SCHERING |
Manufacturing (CMC) |
Approval |
06/26/1979 |
TECHNETIUM TC 99M MPI MDP NDA #018141 |
ORIG-1 |
TECHNETIUM TC-99M MEDRONATE KIT |
GE HEALTHCARE |
Type 5 - New Formulation or New Manufacturer |
Approval |
06/26/1979 |
RIFADIN NDA #050420 |
SUPPL-49 |
RIFAMPIN |
SANOFI AVENTIS US |
Labeling |
Approval |
06/26/1979 |
PENICILLIN G POTASSIUM ANDA #060306 |
ORIG-1 |
PENICILLIN G POTASSIUM |
TEVA |
|
Approval |
06/27/1979 |
DEXEDRINE SPANSULE NDA #017078 |
SUPPL-8 |
DEXTROAMPHETAMINE SULFATE |
IMPAX LABS INC |
Labeling |
Approval |
06/28/1979 |
MEPHYTON NDA #010104 |
SUPPL-6 |
PHYTONADIONE |
BAUSCH |
Labeling |
Approval |
06/28/1979 |
NUBAIN NDA #018024 |
SUPPL-1 |
NALBUPHINE HYDROCHLORIDE |
ENDO OPERATIONS |
Labeling |
Approval |
06/28/1979 |
DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER NDA #018229 |
ORIG-1 |
DEXTROSE; SODIUM CHLORIDE |
B BRAUN |
Type 5 - New Formulation or New Manufacturer |
Approval |
06/28/1979 |
CLEOCIN HYDROCHLORIDE NDA #050162 |
SUPPL-64 |
CLINDAMYCIN HYDROCHLORIDE |
PFIZER |
Labeling |
Approval |
06/29/1979 |
FURADANTIN NDA #008693 |
SUPPL-17 |
NITROFURANTOIN |
PROCTER AND GAMBLE |
Manufacturing (CMC) |
Approval |
06/29/1979 |
ESIDRIX NDA #011793 |
SUPPL-45 |
HYDROCHLOROTHIAZIDE |
NOVARTIS |
Manufacturing (CMC) |
Approval |
06/29/1979 |
ESIDRIX NDA #011793 |
SUPPL-46 |
HYDROCHLOROTHIAZIDE |
NOVARTIS |
Manufacturing (CMC) |
Approval |
06/29/1979 |
ESIDRIX NDA #011793 |
SUPPL-47 |
HYDROCHLOROTHIAZIDE |
NOVARTIS |
Manufacturing (CMC) |
Approval |
06/29/1979 |
DARVOCET-N 100 NDA #017122 |
SUPPL-16 |
ACETAMINOPHEN; PROPOXYPHENE NAPSYLATE |
XANODYNE PHARM |
Manufacturing (CMC) |
Approval |
06/29/1979 |
DARVOCET-N 50 NDA #017122 |
SUPPL-16 |
ACETAMINOPHEN; PROPOXYPHENE NAPSYLATE |
XANODYNE PHARM |
Manufacturing (CMC) |
Approval |
06/29/1979 |
MONISTAT 7 NDA #017450 |
SUPPL-15 |
MICONAZOLE NITRATE |
MEDTECH PRODUCTS |
Manufacturing (CMC) |
Approval |
06/29/1979 |
SLOW-K NDA #017476 |
SUPPL-13 |
POTASSIUM CHLORIDE |
NOVARTIS |
Manufacturing (CMC) |
Approval |
06/29/1979 |
TAGAMET NDA #017920 |
SUPPL-19 |
CIMETIDINE |
GLAXOSMITHKLINE |
Labeling |
Approval |