(Unrated) |
INH (Generic Drug)
|
Company:
NOVARTIS
Active Ingredient(s):
ISONIAZID
FDA#:
(ANDA) 080935
|
(Unrated) |
TRAL (Brand Name Drug)
|
Company:
ABBOTT
Active Ingredient(s):
HEXOCYCLIUM METHYLSULFATE
FDA#:
(NDA) 010599
Review:
S Standard review drug
|
(Unrated) |
MINIRIN (Brand Name Drug)
|
Company:
FERRING
Active Ingredient(s):
DESMOPRESSIN ACETATE
FDA#:
(NDA) 021333
Review:
S Standard review drug
|
(Unrated) |
PENTACARINAT (Generic Drug)
|
Company:
ARMOUR PHARM
Active Ingredient(s):
PENTAMIDINE ISETHIONATE
FDA#:
(ANDA) 073447
|
(Unrated) |
FLORINEF (Brand Name Drug)
|
Company:
KING PHARMS
Active Ingredient(s):
FLUDROCORTISONE ACETATE
FDA#:
(NDA) 010060
Review:
S Standard review drug
|
(Unrated) |
LENTE INSULIN (Brand Name Drug)
|
Company:
NOVO NORDISK INC
Active Ingredient(s):
INSULIN ZINC SUSP BEEF
FDA#:
(NDA) 017998
Review:
S Standard review drug
|
(Unrated) |
LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE
|
Company:
LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE
(ANDA # 076029)
Active Ingredient(s):
• LOPERAMIDE HYDROCHLORIDE; SIMETHICONE
|
(Unrated) |
TRAVASOL 4.25% IN DEXTROSE 10% IN PLASTIC CONTAINER (Brand Name Drug)
|
Company:
BAXTER HLTHCARE
Active Ingredient(s):
AMINO ACIDS; DEXTROSE
FDA#:
(NDA) 019520
Review:
S Standard review drug
|
(Unrated) |
ARIXTRA (Brand Name Drug)
|
Company:
GLAXOSMITHKLINE
Active Ingredient(s):
FONDAPARINUX SODIUM
FDA#:
(NDA) 021345
Review:
P Priority review drug
|
(Unrated) |
ADVAIR DISKUS 100/50 (Brand Name Drug)
|
Company:
GLAXOSMITHKLINE
Active Ingredient(s):
FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE
FDA#:
(NDA) 021077
Review:
S Standard review drug
|
(Unrated) |
LUXIQ (Brand Name Drug)
|
Company:
STIEFEL LABS INC
Active Ingredient(s):
BETAMETHASONE VALERATE
FDA#:
(NDA) 020934
Review:
S Standard review drug
|
(Unrated) |
PREDNISONE
|
Company:
PREDNISONE
(NDA # 017109)
Active Ingredient(s):
• PREDNISONE
|
(Unrated) |
NEUPRO (Brand Name Drug)
|
Company:
SCHWARZ BIOSCIENCES
Active Ingredient(s):
ROTIGOTINE
FDA#:
(NDA) 021829
Review:
S Standard review drug
|
(Unrated) |
PROFEN (Generic Drug)
|
Company:
LEINER
Active Ingredient(s):
IBUPROFEN
FDA#:
(ANDA) 071265
|
(Unrated) |
PRE-SATE (Brand Name Drug)
|
Company:
PARKE DAVIS
Active Ingredient(s):
CHLORPHENTERMINE HYDROCHLORIDE
FDA#:
(NDA) 014696
Review:
S Standard review drug
|
(Unrated) |
JANIMINE (Brand Name Drug)
|
Company:
ABBOTT
Active Ingredient(s):
IMIPRAMINE HYDROCHLORIDE
FDA#:
(NDA) 017895
Review:
P Priority review drug
|
(Unrated) |
VIVACTIL
|
Company:
VIVACTIL
(NDA # 016012)
Active Ingredient(s):
• PROTRIPTYLINE HYDROCHLORIDE
|
(Unrated) |
CORTONE
|
Company:
CORTONE
(NDA # 007110)
Active Ingredient(s):
• CORTISONE ACETATE
|
(Unrated) |
INNOHEP (Brand Name Drug)
|
Company:
PHARMION LLC
Active Ingredient(s):
TINZAPARIN SODIUM
FDA#:
(NDA) 020484
Review:
S Standard review drug
|
(Unrated) |
SOMAVERT (Brand Name Drug)
|
Company:
PHARMACIA AND UPJOHN
Active Ingredient(s):
PEGVISOMANT
FDA#:
(NDA) 021106
Review:
P Priority review drug
O Orphan drug
|
(Unrated) |
ZOVIRAX
|
Company:
ZOVIRAX
(NDA # 018603)
Active Ingredient(s):
• ACYCLOVIR
• ACYCLOVIR SODIUM
|
(Unrated) |
CU-7 (Brand Name Drug)
|
Company:
GD SEARLE LLC
Active Ingredient(s):
COPPER
FDA#:
(NDA) 017408
Review:
P Priority review drug
|
(Unrated) |
ISOVUE-370
|
Company:
ISOVUE-370
(NDA # 018735)
Active Ingredient(s):
• IOPAMIDOL
|
(Unrated) |
AMINOPHYLLIN
|
Company:
AMINOPHYLLIN
(NDA # 002386)
Active Ingredient(s):
• AMINOPHYLLINE
|
(Unrated) |
DEXTROSE 7.7% IN PLASTIC CONTAINER (Brand Name Drug)
|
Company:
B BRAUN
Active Ingredient(s):
DEXTROSE
FDA#:
(NDA) 019626
Review:
S Standard review drug
|
(Unrated) |
TEKTURNA HCT (Brand Name Drug)
|
Company:
NOVARTIS
Active Ingredient(s):
ALISKIREN HEMIFUMARATE; HYDROCHLOROTHIAZIDE
FDA#:
(NDA) 022107
Review:
S Standard review drug
|
(Unrated) |
MIRAPEX (Brand Name Drug)
|
Company:
BOEHRINGER INGELHEIM
Active Ingredient(s):
PRAMIPEXOLE DIHYDROCHLORIDE
FDA#:
(NDA) 020667
Review:
S Standard review drug
|
(Unrated) |
GLUCOTROL XL (Brand Name Drug)
|
Company:
PFIZER
Active Ingredient(s):
GLIPIZIDE
FDA#:
(NDA) 020329
Review:
S Standard review drug
|
(Unrated) |
MYLAXEN (Brand Name Drug)
|
Company:
MEDPOINTE PHARM HLC
Active Ingredient(s):
HEXAFLUORENIUM BROMIDE
FDA#:
(NDA) 009789
Review:
S Standard review drug
|
(Unrated) |
ZOLINZA (Brand Name Drug)
|
Company:
MERCK
Active Ingredient(s):
VORINOSTAT
FDA#:
(NDA) 021991
Review:
P Priority review drug
O Orphan drug
|
(Unrated) |
LANSOPRAZOLE (Generic Drug)
|
Company:
TEVA PHARMS
Active Ingredient(s):
LANSOPRAZOLE
FDA#:
(ANDA) 077255
|
(Unrated) |
FENOLDOPAM MESYLATE
|
Company:
FENOLDOPAM MESYLATE
(ANDA # 076582)
Active Ingredient(s):
• FENOLDOPAM MESYLATE
|
(Unrated) |
PROBENECID
|
Company:
PROBENECID
(ANDA # 083740)
Active Ingredient(s):
• PROBENECID
|
(Unrated) |
NEOTHYLLINE
|
Company:
NEOTHYLLINE
(NDA # 007794)
Active Ingredient(s):
• DYPHYLLINE
|
(Unrated) |
AXERT (Brand Name Drug)
|
Company:
ORTHO MCNEIL JANSSEN
Active Ingredient(s):
ALMOTRIPTAN MALATE
FDA#:
(NDA) 021001
Review:
S Standard review drug
|
(Unrated) |
HALCION (Brand Name Drug)
|
Company:
PHARMACIA AND UPJOHN
Active Ingredient(s):
TRIAZOLAM
FDA#:
(NDA) 017892
Review:
P Priority review drug
|
(Unrated) |
TECHNESCAN GLUCEPTATE (Brand Name Drug)
|
Company:
DRAXIMAGE
Active Ingredient(s):
TECHNETIUM TC-99M GLUCEPTATE KIT
FDA#:
(NDA) 018272
Review:
S Standard review drug
|
(Unrated) |
MOXAM (Brand Name Drug)
|
Company:
LILLY
Active Ingredient(s):
MOXALACTAM DISODIUM
FDA#:
(NDA) 050550
Review:
P Priority review drug
|
(Unrated) |
ETRAFON-FORTE (Brand Name Drug)
|
Company:
SCHERING
Active Ingredient(s):
AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE
FDA#:
(NDA) 014713
Review:
S Standard review drug
|
(Unrated) |
PROSTEP (Brand Name Drug)
|
Company:
AVEVA
Active Ingredient(s):
NICOTINE
FDA#:
(NDA) 019983
Review:
S Standard review drug
|
(Unrated) |
TRIMPEX (Brand Name Drug)
|
Company:
ROCHE
Active Ingredient(s):
TRIMETHOPRIM
FDA#:
(NDA) 017952
Review:
S Standard review drug
|
(Unrated) |
ETHRIL 500 (Generic Drug)
|
Company:
BRISTOL MYERS SQUIBB
Active Ingredient(s):
ERYTHROMYCIN STEARATE
FDA#:
(ANDA) 061605
|
(Unrated) |
POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% IN PLASTIC CONTAINER
|
Company:
POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% IN PLASTIC CONTAINER
(NDA # 018744)
Active Ingredient(s):
• DEXTROSE; POTASSIUM CHLORIDE
|
(Unrated) |
ULTRAGRIS-330 (Generic Drug)
|
Company:
PLIVA
Active Ingredient(s):
GRISEOFULVIN, ULTRAMICROCRYSTALLINE
FDA#:
(ANDA) 062646
|
(Unrated) |
LITHOSTAT (Brand Name Drug)
|
Company:
MISSION PHARMA
Active Ingredient(s):
ACETOHYDROXAMIC ACID
FDA#:
(NDA) 018749
Review:
P Priority review drug
|
(Unrated) |
HYDROSERPINE PLUS (R-H-H) (Generic Drug)
|
Company:
IVAX PHARMS
Active Ingredient(s):
HYDRALAZINE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE; RESERPINE
FDA#:
(ANDA) 083877
|
(Unrated) |
POTASSIUM CHLORIDE 0.15% IN DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER (Brand Name
|
Company:
B BRAUN
Active Ingredient(s):
DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE
FDA#:
(NDA) 019630
Review:
S Standard review drug
|
(Unrated) |
MEPERIDINE AND ATROPINE SULFATE (Generic Drug)
|
Company:
WYETH AYERST
Active Ingredient(s):
ATROPINE SULFATE; MEPERIDINE HYDROCHLORIDE
FDA#:
(ANDA) 085121
|
(Unrated) |
IBUPROFEN
|
Company:
IBUPROFEN
(NDA # 021472)
Active Ingredient(s):
• IBUPROFEN
|
(Unrated) |
CHLORPHENIRAMINE MALEATE AND PHENYLPROPANOLAMINE HYDROCHLORIDE (Generic Drug)
|
Company:
SANDOZ
Active Ingredient(s):
CHLORPHENIRAMINE MALEATE; PHENYLPROPANOLAMINE HYDROCHLORIDE
FDA#:
(ANDA) 088940
|
(Unrated) |
MYOSCINT (Brand Name Drug)
|
Company:
CENTOCOR INC
Active Ingredient(s):
IMCIROMAB PENTETATE
FDA#:
(BLA) 103634
|
(Unrated) |
PRISMASOL BGK 2/0 IN PLASTIC CONTAINER (Brand Name Drug)
|
Company:
GAMBRO RENAL PRODS
Active Ingredient(s):
CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE
FDA#:
(NDA) 021703
Review:
S Standard review drug
|
(Unrated) |
HIPPURAN I 131 (Brand Name Drug)
|
Company:
MALLINCKRODT
Active Ingredient(s):
IODOHIPPURATE SODIUM, I-131
FDA#:
(NDA) 016666
Review:
S Standard review drug
|
(Unrated) |
EPIFOAM (Generic Drug)
|
Company:
SCHWARZ PHARMA
Active Ingredient(s):
HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE
FDA#:
(ANDA) 086457
|
(Unrated) |
METOCURINE IODIDE (Generic Drug)
|
Company:
QUAD PHARMS
Active Ingredient(s):
METOCURINE IODIDE
FDA#:
(ANDA) 089443
|
(Unrated) |
FENTANYL-25
|
Company:
FENTANYL-25
(ANDA # 076258)
Active Ingredient(s):
• FENTANYL
|
(Unrated) |
HEPARIN SODIUM 12,500 UNITS IN DEXTROSE 5% (Brand Name Drug)
|
Company:
HOSPIRA
Active Ingredient(s):
HEPARIN SODIUM
FDA#:
(NDA) 018911
Review:
S Standard review drug
|
(Unrated) |
CLAFORAN
|
Company:
CLAFORAN
(NDA # 050547)
Active Ingredient(s):
• CEFOTAXIME SODIUM
|
(Unrated) |
POTASSIUM CHLORIDE 20MEQ IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER (Brand Name Drug)
|
Company:
HOSPIRA
Active Ingredient(s):
POTASSIUM CHLORIDE; SODIUM CHLORIDE
FDA#:
(NDA) 019686
Review:
S Standard review drug
|
(Unrated) |
POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER (Brand Name
|
Company:
HOSPIRA
Active Ingredient(s):
DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE
FDA#:
(NDA) 018365
Review:
S Standard review drug
|
(Unrated) |
TECHNETIUM TC 99M DIPHOSPHONATE-TIN KIT (Brand Name Drug)
|
Company:
GE HEALTHCARE
Active Ingredient(s):
TECHNETIUM TC-99M ETIDRONATE KIT
FDA#:
(NDA) 017562
Review:
S Standard review drug
|
(Unrated) |
BETOPTIC S (Brand Name Drug)
|
Company:
ALCON
Active Ingredient(s):
BETAXOLOL HYDROCHLORIDE
FDA#:
(NDA) 019845
Review:
S Standard review drug
|
(Unrated) |
M.V.I.-12 (WITHOUT VITAMIN K) (Brand Name Drug)
|
Company:
HOSPIRA
Active Ingredient(s):
ASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; DEXPANTHENOL; ERGOCALCIFEROL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN PHOSPHATE SODIUM; THIAMINE HYDROCHLORIDE; VITAMIN A; VITAMIN E
FDA#:
(NDA) 008809
Review:
S Standard review drug
|
(Unrated) |
DESOXYN (Brand Name Drug)
|
Company:
OVATION PHARMS
Active Ingredient(s):
METHAMPHETAMINE HYDROCHLORIDE
FDA#:
(NDA) 005378
|
(Unrated) |
RIBAVIRIN
|
Company:
RIBAVIRIN
(ANDA # 076192)
Active Ingredient(s):
• RIBAVIRIN
|
(Unrated) |
SYMBICORT (Brand Name Drug)
|
Company:
ASTRAZENECA
Active Ingredient(s):
BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE
FDA#:
(NDA) 021929
Review:
S Standard review drug
|
(Unrated) |
AEROBID (Brand Name Drug)
|
Company:
ROCHE PALO
Active Ingredient(s):
FLUNISOLIDE
FDA#:
(NDA) 018340
Review:
S Standard review drug
|
(Unrated) |
XYLOCAINE W/ EPINEPHRINE
|
Company:
XYLOCAINE W/ EPINEPHRINE
(NDA # 006488)
Active Ingredient(s):
• EPINEPHRINE; LIDOCAINE HYDROCHLORIDE
|
(Unrated) |
OMNIPAQUE 240
|
Company:
OMNIPAQUE 240
(NDA # 018956)
Active Ingredient(s):
• IOHEXOL
|
(Unrated) |
FULVICIN P/G (Generic Drug)
|
Company:
SCHERING
Active Ingredient(s):
GRISEOFULVIN, ULTRAMICROCRYSTALLINE
FDA#:
(ANDA) 061996
|
(Unrated) |
NITROMIST (Brand Name Drug)
|
Company:
NOVADEL
Active Ingredient(s):
NITROGLYCERIN
FDA#:
(NDA) 021780
Review:
S Standard review drug
|
(Unrated) |
TRIPHED (Generic Drug)
|
Company:
TEVA
Active Ingredient(s):
PSEUDOEPHEDRINE HYDROCHLORIDE; TRIPROLIDINE HYDROCHLORIDE
FDA#:
(ANDA) 088630
|
(Unrated) |
PANDEL (Brand Name Drug)
|
Company:
SAVAGE LABS
Active Ingredient(s):
HYDROCORTISONE PROBUTATE
FDA#:
(NDA) 020453
Review:
S Standard review drug
|
(Unrated) |
AMPHADASE (Brand Name Drug)
|
Company:
AMPHASTAR PHARM
Active Ingredient(s):
HYALURONIDASE
FDA#:
(NDA) 021665
Review:
P Priority review drug
|
(Unrated) |
TETREX
|
Company:
TETREX
(NDA # 050212)
Active Ingredient(s):
• TETRACYCLINE PHOSPHATE COMPLEX
|
(Unrated) |
HYPAQUE SODIUM 20% (Brand Name Drug)
|
Company:
GE HEALTHCARE
Active Ingredient(s):
DIATRIZOATE SODIUM
FDA#:
(NDA) 009561
Review:
P Priority review drug
|
(Unrated) |
E-MYCIN E (Generic Drug)
|
Company:
PHARMACIA AND UPJOHN
Active Ingredient(s):
ERYTHROMYCIN ETHYLSUCCINATE
FDA#:
(ANDA) 062198
|
(Unrated) |
AZULFIDINE
|
Company:
AZULFIDINE
(NDA # 007073)
Active Ingredient(s):
• SULFASALAZINE
|
(Unrated) |
ETOPOPHOS PRESERVATIVE FREE
|
Company:
ETOPOPHOS PRESERVATIVE FREE
(NDA # 020457)
Active Ingredient(s):
• ETOPOSIDE PHOSPHATE
|
(Unrated) |
COLESTID
|
Company:
COLESTID
(NDA # 017563)
Active Ingredient(s):
• COLESTIPOL HYDROCHLORIDE
|
(Unrated) |
MECLIZINE HYDROCHLORIDE
|
Company:
MECLIZINE HYDROCHLORIDE
(ANDA # 040179)
Active Ingredient(s):
• MECLIZINE HYDROCHLORIDE
|
(Unrated) |
FUDR (Brand Name Drug)
|
Company:
HOSPIRA
Active Ingredient(s):
FLOXURIDINE
FDA#:
(NDA) 016929
Review:
P Priority review drug
|
(Unrated) |
FENTANYL-50
|
Company:
FENTANYL-50
(ANDA # 076258)
Active Ingredient(s):
• FENTANYL
|
(Unrated) |
RIFADIN
|
Company:
RIFADIN
(NDA # 050420)
Active Ingredient(s):
• RIFAMPIN
|
(Unrated) |
AMBIEN (Brand Name Drug)
|
Company:
SANOFI AVENTIS US
Active Ingredient(s):
ZOLPIDEM TARTRATE
FDA#:
(NDA) 019908
Review:
S Standard review drug
|
(Unrated) |
PREDNICEN-M (Generic Drug)
|
Company:
SCHWARZ PHARMA
Active Ingredient(s):
PREDNISONE
FDA#:
(ANDA) 084655
|
(Unrated) |
MONISTAT 7
|
Company:
MONISTAT 7
(NDA # 017450)
Active Ingredient(s):
• MICONAZOLE NITRATE
|
(Unrated) |
ZYPREXA
|
Company:
ZYPREXA
(NDA # 020592)
Active Ingredient(s):
• OLANZAPINE
|
(Unrated) |
OXYCODONE 2.5/APAP 500 (Generic Drug)
|
Company:
BRISTOL MYERS SQUIBB
Active Ingredient(s):
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
FDA#:
(ANDA) 085910
|
(Unrated) |
FULVICIN P/G 165 (Generic Drug)
|
Company:
SCHERING
Active Ingredient(s):
GRISEOFULVIN, ULTRAMICROCRYSTALLINE
FDA#:
(ANDA) 061996
|
(Unrated) |
PROMETHAZINE HYDROCHLORIDE PLAIN (Brand Name Drug)
|
Company:
ANI PHARMS
Active Ingredient(s):
PROMETHAZINE HYDROCHLORIDE
FDA#:
(NDA) 008381
Review:
S Standard review drug
|
(Unrated) |
PROPOXYPHENE HYDROCHLORIDE AND ACETAMINOPHEN
|
Company:
PROPOXYPHENE HYDROCHLORIDE AND ACETAMINOPHEN
(ANDA # 040139)
Active Ingredient(s):
• ACETAMINOPHEN; PROPOXYPHENE HYDROCHLORIDE
|
(Unrated) |
NUTROPIN AQ PEN (Brand Name Drug)
|
Company:
GENENTECH
Active Ingredient(s):
SOMATROPIN RECOMBINANT
FDA#:
(NDA) 020522
Review:
S Standard review drug
|
(Unrated) |
VENTOLIN
|
Company:
VENTOLIN
(NDA # 018473)
Active Ingredient(s):
• ALBUTEROL
• ALBUTEROL SULFATE
|
(Unrated) |
VIREAD (Brand Name Drug)
|
Company:
GILEAD
Active Ingredient(s):
TENOFOVIR DISOPROXIL FUMARATE
FDA#:
(NDA) 021356
Review:
P Priority review drug
|
(Unrated) |
DESIPRAMINE HYDROCHLORIDE
|
Company:
DESIPRAMINE HYDROCHLORIDE
(ANDA # 071588)
Active Ingredient(s):
• DESIPRAMINE HYDROCHLORIDE
|
(Unrated) |
ATRACURIUM BESYLATE
|
Company:
ATRACURIUM BESYLATE
(ANDA # 074632)
Active Ingredient(s):
• ATRACURIUM BESYLATE
|
(Unrated) |
HYDRALAZINE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
|
Company:
HYDRALAZINE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
(ANDA # 085440)
Active Ingredient(s):
• HYDRALAZINE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE
|
(Unrated) |
KANTREX
|
Company:
KANTREX
(ANDA # 060516)
Active Ingredient(s):
• KANAMYCIN SULFATE
|
(Unrated) |
DIABETA (Brand Name Drug)
|
Company:
SANOFI AVENTIS US
Active Ingredient(s):
GLYBURIDE
FDA#:
(NDA) 017532
Review:
S Standard review drug
|
