(Unrated) |
RENOQUID (Brand Name Drug)
|
Company:
GLENWOOD
Active Ingredient(s):
SULFACYTINE
FDA#:
(NDA) 017569
Review:
P Priority review drug
|
(Unrated) |
OLMESARTAN MEDOXOMIL; HYDROCHLOROTHIAZIDE (Generic Drug)
|
Company:
MYLAN PHARMA
Active Ingredient(s):
OLMESARTAN MEDOXOMIL; HYDROCHLOROTHIAZIDE
FDA#:
(ANDA) 078827
|
(Unrated) |
SSD AF (Brand Name Drug)
|
Company:
DR REDDYS LA
Active Ingredient(s):
SILVER SULFADIAZINE
FDA#:
(NDA) 018578
Review:
S Standard review drug
|
(Unrated) |
BRONKOMETER (Brand Name Drug)
|
Company:
SANOFI AVENTIS US
Active Ingredient(s):
ISOETHARINE MESYLATE
FDA#:
(NDA) 012339
Review:
S Standard review drug
|
(Unrated) |
ADAGEN (Brand Name Drug)
|
Company:
ENZON PHARMS
Active Ingredient(s):
PEGADEMASE BOVINE
FDA#:
(NDA) 019818
Review:
P Priority review drug
O Orphan drug
|
(Unrated) |
NOVOLOG MIX 50/50 (Brand Name Drug)
|
Company:
NOVO NORDISK INC
Active Ingredient(s):
INSULIN ASPART PROTAMINE RECOMBINANT; INSULIN ASPART RECOMBINANT
FDA#:
(NDA) 021810
Review:
S Standard review drug
|
(Unrated) |
FULVICIN P/G (Generic Drug)
|
Company:
SCHERING
Active Ingredient(s):
GRISEOFULVIN, ULTRAMICROCRYSTALLINE
FDA#:
(ANDA) 061996
|
(Unrated) |
MUCOMYST W/ ISOPROTERENOL (Brand Name Drug)
|
Company:
MEAD JOHNSON
Active Ingredient(s):
ACETYLCYSTEINE; ISOPROTERENOL HYDROCHLORIDE
FDA#:
(NDA) 017366
Review:
S Standard review drug
|
(Unrated) |
THALITONE
|
Company:
THALITONE
(NDA # 019574)
Active Ingredient(s):
• CHLORTHALIDONE
|
(Unrated) |
TEPANIL (Brand Name Drug)
|
Company:
3M
Active Ingredient(s):
DIETHYLPROPION HYDROCHLORIDE
FDA#:
(NDA) 011673
Review:
S Standard review drug
|
(Unrated) |
ENALAPRILAT
|
Company:
ENALAPRILAT
(ANDA # 075456)
Active Ingredient(s):
• ENALAPRILAT
|
(Unrated) |
BETAMETHASONE DIPROPIONATE
|
Company:
BETAMETHASONE DIPROPIONATE
(NDA # 019136)
Active Ingredient(s):
• BETAMETHASONE DIPROPIONATE
|
(Unrated) |
CHOLOGRAFIN MEGLUMINE (Brand Name Drug)
|
Company:
BRACCO
Active Ingredient(s):
IODIPAMIDE MEGLUMINE
FDA#:
(NDA) 009321
Review:
S Standard review drug
|
(Unrated) |
VELOSEF
|
Company:
VELOSEF
(NDA # 050530)
Active Ingredient(s):
• CEPHRADINE
|
(Unrated) |
CLOTRIMAZOLE
|
Company:
CLOTRIMAZOLE
(ANDA # 072640)
Active Ingredient(s):
• CLOTRIMAZOLE
|
(Unrated) |
NORETHIN 1/50M-21 (Generic Drug)
|
Company:
WATSON LABS
Active Ingredient(s):
MESTRANOL; NORETHINDRONE
FDA#:
(ANDA) 071539
|
(Unrated) |
GLYCORT (Generic Drug)
|
Company:
HERAN
Active Ingredient(s):
HYDROCORTISONE
FDA#:
(ANDA) 087489
|
(Unrated) |
AMOXICILLIN
|
Company:
AMOXICILLIN
(ANDA # 061926)
Active Ingredient(s):
• AMOXICILLIN
|
(Unrated) |
AMINOSYN-HF 8% (Brand Name Drug)
|
Company:
HOSPIRA
Active Ingredient(s):
AMINO ACIDS
FDA#:
(NDA) 020345
Review:
S Standard review drug
|
(Unrated) |
FLUDROCORTISONE ACETATE
|
Company:
FLUDROCORTISONE ACETATE
(ANDA # 040425)
Active Ingredient(s):
• FLUDROCORTISONE ACETATE
|
(Unrated) |
NADOLOL
|
Company:
NADOLOL
(ANDA # 074172)
Active Ingredient(s):
• NADOLOL
|
(Unrated) |
MYOVIEW 30ML (Brand Name Drug)
|
Company:
GE HEALTHCARE
Active Ingredient(s):
TECHNETIUM TC-99M TETROFOSMIN KIT
FDA#:
(NDA) 020372
Review:
S Standard review drug
|
(Unrated) |
EVISTA
|
Company:
EVISTA
(NDA # 020815)
Active Ingredient(s):
• RALOXIFENE HYDROCHLORIDE
|
(Unrated) |
NORETHINDRONE AND ETHINYL ESTRADIOL
|
Company:
NORETHINDRONE AND ETHINYL ESTRADIOL
(ANDA # 070684)
Active Ingredient(s):
• ETHINYL ESTRADIOL; NORETHINDRONE
|
(Unrated) |
ISTALOL (Brand Name Drug)
|
Company:
ISTA PHARMS
Active Ingredient(s):
TIMOLOL MALEATE
FDA#:
(NDA) 021516
Review:
S Standard review drug
|
(Unrated) |
ESGIC (Generic Drug)
|
Company:
FOREST PHARMS
Active Ingredient(s):
ACETAMINOPHEN; BUTALBITAL; CAFFEINE
FDA#:
(ANDA) 089660
|
(Unrated) |
TECHNECOLL (Brand Name Drug)
|
Company:
MALLINCKRODT
Active Ingredient(s):
TECHNETIUM TC-99M SULFUR COLLOID KIT
FDA#:
(NDA) 017059
Review:
S Standard review drug
|
(Unrated) |
OXYCODONE HYDROCHLORIDE
|
Company:
OXYCODONE HYDROCHLORIDE
(ANDA # 075923)
Active Ingredient(s):
• OXYCODONE HYDROCHLORIDE
|
(Unrated) |
AMINOSYN II 3.5% M IN PLASTIC CONTAINER (Brand Name Drug)
|
Company:
ABBOTT
Active Ingredient(s):
AMINO ACIDS; MAGNESIUM ACETATE; POTASSIUM ACETATE; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE
FDA#:
(NDA) 019493
Review:
S Standard review drug
|
(Unrated) |
OPTIMINE (Brand Name Drug)
|
Company:
SCHERING
Active Ingredient(s):
AZATADINE MALEATE
FDA#:
(NDA) 017601
Review:
S Standard review drug
|
(Unrated) |
GENESA (Brand Name Drug)
|
Company:
GENSIA AUTOMEDICS
Active Ingredient(s):
ARBUTAMINE HYDROCHLORIDE
FDA#:
(NDA) 020420
Review:
S Standard review drug
|
(Unrated) |
CHLORPROMAZINE HYDROCHLORIDE INTENSOL
|
Company:
CHLORPROMAZINE HYDROCHLORIDE INTENSOL
(ANDA # 088157)
Active Ingredient(s):
• CHLORPROMAZINE HYDROCHLORIDE
|
(Unrated) |
UROPLUS DS (Generic Drug)
|
Company:
SHIONOGI
Active Ingredient(s):
SULFAMETHOXAZOLE; TRIMETHOPRIM
FDA#:
(ANDA) 071816
|
(Unrated) |
EVAMIST (Brand Name Drug)
|
Company:
KV PHARM
Active Ingredient(s):
ESTRADIOL
FDA#:
(NDA) 022014
Review:
S Standard review drug
|
(Unrated) |
DELESTROGEN (Brand Name Drug)
|
Company:
JHP PHARMS
Active Ingredient(s):
ESTRADIOL VALERATE
FDA#:
(NDA) 009402
|
(Unrated) |
VANTIN
|
Company:
VANTIN
(NDA # 050674)
Active Ingredient(s):
• CEFPODOXIME PROXETIL
|
(Unrated) |
PENTETATE ZINC TRISODIUM (Brand Name Drug)
|
Company:
HAMELN PHARMS
Active Ingredient(s):
PENTETATE ZINC TRISODIUM
FDA#:
(NDA) 021751
Review:
P Priority review drug
O Orphan drug
|
(Unrated) |
BLOCADREN (Brand Name Drug)
|
Company:
MERCK
Active Ingredient(s):
TIMOLOL MALEATE
FDA#:
(NDA) 018017
Review:
P Priority review drug
|
(Unrated) |
MECLOFENAMATE SODIUM
|
Company:
MECLOFENAMATE SODIUM
(ANDA # 070400)
Active Ingredient(s):
• MECLOFENAMATE SODIUM
|
(Unrated) |
ETHRANE (Brand Name Drug)
|
Company:
BAXTER HLTHCARE CORP
Active Ingredient(s):
ENFLURANE
FDA#:
(NDA) 017087
Review:
S Standard review drug
|
(Unrated) |
DEXTROSE 2.5% IN PLASTIC CONTAINER
|
Company:
DEXTROSE 2.5% IN PLASTIC CONTAINER
(NDA # 018358)
Active Ingredient(s):
• DEXTROSE
|
(Unrated) |
CHLOROPTIC-P S.O.P. (Generic Drug)
|
Company:
ALLERGAN
Active Ingredient(s):
CHLORAMPHENICOL; PREDNISOLONE
FDA#:
(ANDA) 061188
|
(Unrated) |
PORTALAC (Generic Drug)
|
Company:
SOLVAY
Active Ingredient(s):
LACTULOSE
FDA#:
(ANDA) 072374
|
(Unrated) |
BAROS (Brand Name Drug)
|
Company:
LAFAYETTE PHARMS
Active Ingredient(s):
SODIUM BICARBONATE; TARTARIC ACID
FDA#:
(NDA) 018509
Review:
S Standard review drug
|
(Unrated) |
ETOMIDATE
|
Company:
ETOMIDATE
(ANDA # 074593)
Active Ingredient(s):
• ETOMIDATE
|
(Unrated) |
COMBUNOX (Brand Name Drug)
|
Company:
FOREST LABS
Active Ingredient(s):
IBUPROFEN; OXYCODONE HYDROCHLORIDE
FDA#:
(NDA) 021378
Review:
S Standard review drug
|
(Unrated) |
PHERAZINE VC (Generic Drug)
|
Company:
HALSEY
Active Ingredient(s):
PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE
FDA#:
(ANDA) 088868
|
(Unrated) |
DUODOTE (Brand Name Drug)
|
Company:
MERIDIAN MEDCL
Active Ingredient(s):
ATROPINE; PRALIDOXIME CHLORIDE
FDA#:
(NDA) 021983
Review:
P Priority review drug
|
(Unrated) |
PROHANCE MULTIPACK (Brand Name Drug)
|
Company:
BRACCO
Active Ingredient(s):
GADOTERIDOL
FDA#:
(NDA) 021489
Review:
S Standard review drug
|
(Unrated) |
AMINOSOL 5% (Brand Name Drug)
|
Company:
ABBOTT
Active Ingredient(s):
PROTEIN HYDROLYSATE
FDA#:
(NDA) 005932
Review:
S Standard review drug
|
(Unrated) |
VAGISTAT-1 (Brand Name Drug)
|
Company:
NOVARTIS
Active Ingredient(s):
TIOCONAZOLE
FDA#:
(NDA) 020676
Review:
S Standard review drug
|
(Unrated) |
INDOCYANINE GREEN (Generic Drug)
|
Company:
PULSION MEDCL
Active Ingredient(s):
INDOCYANINE GREEN
FDA#:
(ANDA) 040811
|
(Unrated) |
NORINYL 1+80 21-DAY (Brand Name Drug)
|
Company:
GD SEARLE LLC
Active Ingredient(s):
MESTRANOL; NORETHINDRONE
FDA#:
(NDA) 016724
Review:
S Standard review drug
|
(Unrated) |
GANCICLOVIR (Generic Drug)
|
Company:
RANBAXY
Active Ingredient(s):
GANCICLOVIR
FDA#:
(ANDA) 076457
|
(Unrated) |
REZIPAS (Brand Name Drug)
|
Company:
BRISTOL MYERS SQUIBB
Active Ingredient(s):
AMINOSALICYLIC ACID RESIN COMPLEX
FDA#:
(NDA) 009052
Review:
S Standard review drug
|
(Unrated) |
NORCEPT-E 1/35 28 (Generic Drug)
|
Company:
ORTHO MCNEIL PHARM
Active Ingredient(s):
ETHINYL ESTRADIOL; NORETHINDRONE
FDA#:
(ANDA) 071546
|
(Unrated) |
VIRAC REX (Brand Name Drug)
|
Company:
CHESEBROUGH PONDS
Active Ingredient(s):
UNDECOYLIUM CHLORIDE; UNDECOYLIUM CHLORIDE IODINE COMPLEX
FDA#:
(NDA) 011914
Review:
S Standard review drug
|
(Unrated) |
NASACORT AQ (Brand Name Drug)
|
Company:
SANOFI AVENTIS US
Active Ingredient(s):
TRIAMCINOLONE ACETONIDE
FDA#:
(NDA) 020468
Review:
P Priority review drug
|
(Unrated) |
INDOMETHACIN
|
Company:
INDOMETHACIN
(NDA # 018690)
Active Ingredient(s):
• INDOMETHACIN
|
(Unrated) |
TECHNETIUM TC 99M SULFUR COLLOID
|
Company:
TECHNETIUM TC 99M SULFUR COLLOID
(NDA # 017456)
Active Ingredient(s):
• TECHNETIUM TC-99M SULFUR COLLOID
|
(Unrated) |
CHENIX (Brand Name Drug)
|
Company:
AXCAN SCANDIPHARM
Active Ingredient(s):
CHENODIOL
FDA#:
(NDA) 018513
Review:
P Priority review drug
O Orphan drug
|
(Unrated) |
EFIDAC 24 CHLORPHENIRAMINE MALEATE (Brand Name Drug)
|
Company:
ALZA
Active Ingredient(s):
CHLORPHENIRAMINE MALEATE
FDA#:
(NDA) 019746
Review:
S Standard review drug
|
(Unrated) |
INDOCIN SR
|
Company:
INDOCIN SR
(NDA # 018185)
Active Ingredient(s):
• INDOMETHACIN
|
(Unrated) |
ETRAFON-FORTE (Brand Name Drug)
|
Company:
SCHERING
Active Ingredient(s):
AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE
FDA#:
(NDA) 014713
Review:
S Standard review drug
|
(Unrated) |
TRAVASOL 2.75% SULFITE FREE W/ ELECTROLYTES IN DEXTROSE 5% IN PLASTIC CONTAINER (Brand Name Drug)
|
Company:
BAXTER HLTHCARE
Active Ingredient(s):
AMINO ACIDS; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE
FDA#:
(NDA) 020147
Review:
S Standard review drug
|
(Unrated) |
CEENU (Brand Name Drug)
|
Company:
BRISTOL MYERS SQUIBB
Active Ingredient(s):
LOMUSTINE
FDA#:
(NDA) 017588
Review:
S Standard review drug
|
(Unrated) |
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE
|
Company:
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE
(ANDA # 077075)
Active Ingredient(s):
• ETHINYL ESTRADIOL; NORETHINDRONE ACETATE
|
(Unrated) |
ALMOTRIPTAN MALATE (Generic Drug)
|
Company:
TEVA PHARMS
Active Ingredient(s):
ALMOTRIPTAN MALATE
FDA#:
(ANDA) 078027
|
(Unrated) |
CORTIFOAM (Brand Name Drug)
|
Company:
SCHWARZ PHARMA
Active Ingredient(s):
HYDROCORTISONE ACETATE
FDA#:
(NDA) 017351
Review:
S Standard review drug
|
(Unrated) |
ISOPTIN SR (Brand Name Drug)
|
Company:
RANBAXY
Active Ingredient(s):
VERAPAMIL HYDROCHLORIDE
FDA#:
(NDA) 019152
Review:
S Standard review drug
|
(Unrated) |
ZOFRAN PRESERVATIVE FREE (Brand Name Drug)
|
Company:
GLAXOSMITHKLINE
Active Ingredient(s):
ONDANSETRON HYDROCHLORIDE
FDA#:
(NDA) 020007
Review:
P Priority review drug
|
(Unrated) |
ORTHO CYCLEN-21 (Brand Name Drug)
|
Company:
ORTHO MCNEIL JANSSEN
Active Ingredient(s):
ETHINYL ESTRADIOL; NORGESTIMATE
FDA#:
(NDA) 019653
Review:
S Standard review drug
|
(Unrated) |
SONATA (Brand Name Drug)
|
Company:
KING PHARMS
Active Ingredient(s):
ZALEPLON
FDA#:
(NDA) 020859
Review:
S Standard review drug
|
(Unrated) |
STRIANT (Brand Name Drug)
|
Company:
COLUMBIA LABS
Active Ingredient(s):
TESTOSTERONE
FDA#:
(NDA) 021543
Review:
S Standard review drug
|
(Unrated) |
SURITAL (Brand Name Drug)
|
Company:
PARKEDALE
Active Ingredient(s):
THIAMYLAL SODIUM
FDA#:
(NDA) 007600
Review:
S Standard review drug
|
(Unrated) |
MONOKET (Brand Name Drug)
|
Company:
SCHWARZ
Active Ingredient(s):
ISOSORBIDE MONONITRATE
FDA#:
(NDA) 020215
Review:
S Standard review drug
|
(Unrated) |
MYIDYL (Generic Drug)
|
Company:
USL PHARMA
Active Ingredient(s):
TRIPROLIDINE HYDROCHLORIDE
FDA#:
(ANDA) 087963
|
(Unrated) |
CETIRIZINE HYDROCHLORIDE
|
Company:
CETIRIZINE HYDROCHLORIDE
(ANDA # 076581)
Active Ingredient(s):
• CETIRIZINE HYDROCHLORIDE
|
(Unrated) |
FANSIDAR (Brand Name Drug)
|
Company:
ROCHE
Active Ingredient(s):
PYRIMETHAMINE; SULFADOXINE
FDA#:
(NDA) 018557
Review:
P Priority review drug
|
(Unrated) |
TRANSDERM-NITRO (Brand Name Drug)
|
Company:
NOVARTIS
Active Ingredient(s):
NITROGLYCERIN
FDA#:
(NDA) 020144
|
(Unrated) |
HYPAQUE-CYSTO (Brand Name Drug)
|
Company:
GE HEALTHCARE
Active Ingredient(s):
DIATRIZOATE MEGLUMINE
FDA#:
(NDA) 016403
Review:
P Priority review drug
|
(Unrated) |
KINLYTIC (Brand Name Drug)
|
Company:
MICROBIX BIOSYSTEMS
Active Ingredient(s):
UROKINASE
FDA#:
(NDA) 021846
|
(Unrated) |
BACLOFEN
|
Company:
BACLOFEN
(ANDA # 071260)
Active Ingredient(s):
• BACLOFEN
|
(Unrated) |
DEXONE 1.5 (Generic Drug)
|
Company:
SOLVAY
Active Ingredient(s):
DEXAMETHASONE
FDA#:
(ANDA) 084990
|
 |
A-METHAPRED
|
Company:
A-METHAPRED
(ANDA # 040664)
Active Ingredient(s):
• METHYLPREDNISOLONE SODIUM SUCCINATE
|
(Unrated) |
RABEPRAZOLE SODIUM (Generic Drug)
|
Company:
TEVA
Active Ingredient(s):
RABEPRAZOLE SODIUM
FDA#:
(ANDA) 076822
|
(Unrated) |
THORAZINE
|
Company:
THORAZINE
(NDA # 009149)
Active Ingredient(s):
• CHLORPROMAZINE
• CHLORPROMAZINE HYDROCHLORIDE
|
(Unrated) |
THYTROPAR (Brand Name Drug)
|
Company:
SANOFI AVENTIS US
Active Ingredient(s):
THYROTROPIN
FDA#:
(NDA) 008682
Review:
P Priority review drug
|
(Unrated) |
CAM-AP-ES (Generic Drug)
|
Company:
TG UNITED LABS
Active Ingredient(s):
HYDRALAZINE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE; RESERPINE
FDA#:
(ANDA) 084897
|
(Unrated) |
ETRAFON 2-10 (Brand Name Drug)
|
Company:
SCHERING
Active Ingredient(s):
AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE
FDA#:
(NDA) 014713
Review:
S Standard review drug
|
(Unrated) |
POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER
|
Company:
POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER
(NDA # 019904)
Active Ingredient(s):
• POTASSIUM CHLORIDE
|
(Unrated) |
DEXTROSE 38.5% IN PLASTIC CONTAINER (Brand Name Drug)
|
Company:
ABBOTT
Active Ingredient(s):
DEXTROSE
FDA#:
(NDA) 018923
Review:
S Standard review drug
|
(Unrated) |
VEREGEN (Brand Name Drug)
|
Company:
MEDIGENE
Active Ingredient(s):
SINECATECHINS
FDA#:
(NDA) 021902
Review:
S Standard review drug
|
(Unrated) |
POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER (Brand Name D
|
Company:
HOSPIRA
Active Ingredient(s):
DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE
FDA#:
(NDA) 018362
Review:
S Standard review drug
|
(Unrated) |
PLACIDYL (Brand Name Drug)
|
Company:
ABBOTT
Active Ingredient(s):
ETHCHLORVYNOL
FDA#:
(NDA) 010021
Review:
S Standard review drug
|
(Unrated) |
INDOCIN I.V. (Brand Name Drug)
|
Company:
OVATION PHARMS
Active Ingredient(s):
INDOMETHACIN SODIUM
FDA#:
(NDA) 018878
Review:
P Priority review drug
|
(Unrated) |
ACETAMINOPHEN AND CODEINE PHOSPHATE
|
Company:
ACETAMINOPHEN AND CODEINE PHOSPHATE
(ANDA # 040098)
Active Ingredient(s):
• ACETAMINOPHEN; CODEINE PHOSPHATE
|
(Unrated) |
NEXAVAR (Brand Name Drug)
|
Company:
BAYER PHARMS
Active Ingredient(s):
SORAFENIB TOSYLATE
FDA#:
(NDA) 021923
Review:
P Priority review drug
O Orphan drug
|
(Unrated) |
EDROPHONIUM CHLORIDE
|
Company:
EDROPHONIUM CHLORIDE
(ANDA # 040044)
Active Ingredient(s):
• EDROPHONIUM CHLORIDE
|
(Unrated) |
NEO-RX (Generic Drug)
|
Company:
X GEN PHARMS
Active Ingredient(s):
NEOMYCIN SULFATE
FDA#:
(ANDA) 061579
|
