(Unrated) |
FOVANE (Brand Name Drug)
|
Company:
PFIZER
Active Ingredient(s):
BENZTHIAZIDE
FDA#:
(NDA) 012128
Review:
S Standard review drug
|
(Unrated) |
LIVOSTIN (Brand Name Drug)
|
Company:
NOVARTIS
Active Ingredient(s):
LEVOCABASTINE HYDROCHLORIDE
FDA#:
(NDA) 020219
Review:
P Priority review drug
|
(Unrated) |
ROFERON A (Brand Name Drug)
|
Company:
HOFFMAN-LA ROCHE
Active Ingredient(s):
INTERFERON ALFA-2A
FDA#:
(BLA) 103145
|
(Unrated) |
PRAMIPEXOLE DIHYDROCHLORIDE
|
Company:
PRAMIPEXOLE DIHYDROCHLORIDE
(ANDA # 077724)
Active Ingredient(s):
• PRAMIPEXOLE DIHYDROCHLORIDE
|
(Unrated) |
DEPO-ESTRADIOL (Generic Drug)
|
Company:
PHARMACIA AND UPJOHN
Active Ingredient(s):
ESTRADIOL CYPIONATE
FDA#:
(ANDA) 085470
|
(Unrated) |
PROCTOCORT (Generic Drug)
|
Company:
MONARCH PHARMS
Active Ingredient(s):
HYDROCORTISONE
FDA#:
(ANDA) 083011
|
(Unrated) |
OGEN 1.25 (Generic Drug)
|
Company:
PHARMACIA AND UPJOHN
Active Ingredient(s):
ESTROPIPATE
FDA#:
(ANDA) 083220
|
(Unrated) |
LEVAQUIN
|
Company:
LEVAQUIN
(NDA # 020634)
Active Ingredient(s):
• LEVOFLOXACIN
|
(Unrated) |
DILATRATE-SR (Brand Name Drug)
|
Company:
SCHWARZ PHARMA
Active Ingredient(s):
ISOSORBIDE DINITRATE
FDA#:
(NDA) 019790
Review:
S Standard review drug
|
(Unrated) |
SYMLIN (Brand Name Drug)
|
Company:
AMYLIN
Active Ingredient(s):
PRAMLINTIDE ACETATE
FDA#:
(NDA) 021332
Review:
S Standard review drug
|
(Unrated) |
CORSYM (Brand Name Drug)
|
Company:
UCB INC
Active Ingredient(s):
CHLORPHENIRAMINE POLISTIREX; PHENYLPROPANOLAMINE POLISTIREX
FDA#:
(NDA) 018050
Review:
S Standard review drug
|
(Unrated) |
METHAZOLAMIDE
|
Company:
METHAZOLAMIDE
(ANDA # 040001)
Active Ingredient(s):
• METHAZOLAMIDE
|
(Unrated) |
EXIDINE
|
Company:
EXIDINE
(NDA # 019125)
Active Ingredient(s):
• CHLORHEXIDINE GLUCONATE
|
(Unrated) |
GAVISCON (Brand Name Drug)
|
Company:
SANOFI AVENTIS US
Active Ingredient(s):
ALUMINUM HYDROXIDE; MAGNESIUM TRISILICATE
FDA#:
(NDA) 018685
Review:
S Standard review drug
|
(Unrated) |
PRE-PEN (Brand Name Drug)
|
Company:
ALLERQUEST
Active Ingredient(s):
BENZYL PENICILLOYL-POLYLYSINE
FDA#:
(NDA) 050114
Review:
S Standard review drug
|
(Unrated) |
ACZONE (Brand Name Drug)
|
Company:
ALLERGAN
Active Ingredient(s):
DAPSONE
FDA#:
(NDA) 021794
Review:
S Standard review drug
|
(Unrated) |
RENACIDIN (Brand Name Drug)
|
Company:
UNITED GUARDIAN
Active Ingredient(s):
CITRIC ACID; GLUCONOLACTONE; MAGNESIUM CARBONATE
FDA#:
(NDA) 019481
Review:
P Priority review drug
O Orphan drug
|
(Unrated) |
EMADINE (Brand Name Drug)
|
Company:
ALCON
Active Ingredient(s):
EMEDASTINE DIFUMARATE
FDA#:
(NDA) 020706
Review:
S Standard review drug
|
(Unrated) |
ISONIAZID
|
Company:
ISONIAZID
(NDA # 008428)
Active Ingredient(s):
• ISONIAZID
|
(Unrated) |
ULTRAVIST 150 (Brand Name Drug)
|
Company:
BAYER HLTHCARE
Active Ingredient(s):
IOPROMIDE
FDA#:
(NDA) 020220
Review:
S Standard review drug
|
(Unrated) |
DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
|
Company:
DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
(NDA # 017585)
Active Ingredient(s):
• DEXTROSE; SODIUM CHLORIDE
|
(Unrated) |
TIMOPTIC-XE (Brand Name Drug)
|
Company:
MERCK
Active Ingredient(s):
TIMOLOL MALEATE
FDA#:
(NDA) 020330
Review:
S Standard review drug
|
(Unrated) |
KETOTIFEN FUMARATE
|
Company:
KETOTIFEN FUMARATE
(ANDA # 077200)
Active Ingredient(s):
• KETOTIFEN FUMARATE
|
(Unrated) |
MILRINONE LACTATE IN DEXTROSE 5% (Generic Drug)
|
Company:
APOTEX INC
Active Ingredient(s):
MILRINONE LACTATE
FDA#:
(ANDA) 077151
|
(Unrated) |
ARISTOCORT
|
Company:
ARISTOCORT
(NDA # 011161)
Active Ingredient(s):
• TRIAMCINOLONE
• TRIAMCINOLONE ACETONIDE
• TRIAMCINOLONE DIACETATE
|
(Unrated) |
VISIONBLUE (Brand Name Drug)
|
Company:
DORC
Active Ingredient(s):
TRYPAN BLUE
FDA#:
(NDA) 021670
Review:
P Priority review drug
|
(Unrated) |
ACULAR (Brand Name Drug)
|
Company:
ALLERGAN
Active Ingredient(s):
KETOROLAC TROMETHAMINE
FDA#:
(NDA) 019700
Review:
S Standard review drug
|
(Unrated) |
STADOL PRESERVATIVE FREE (Brand Name Drug)
|
Company:
APOTHECON
Active Ingredient(s):
BUTORPHANOL TARTRATE
FDA#:
(NDA) 017857
Review:
P Priority review drug
|
(Unrated) |
M-ZOLE 7 DUAL PACK (Generic Drug)
|
Company:
ACTAVIS MID ATLANTIC
Active Ingredient(s):
MICONAZOLE NITRATE
FDA#:
(ANDA) 074586
|
(Unrated) |
DILANTIN
|
Company:
DILANTIN
(NDA # 010151)
Active Ingredient(s):
• PHENYTOIN
• PHENYTOIN SODIUM
|
(Unrated) |
HYDROCORTISONE ACETATE
|
Company:
HYDROCORTISONE ACETATE
(NDA # 009637)
Active Ingredient(s):
• HYDROCORTISONE ACETATE
|
(Unrated) |
AMINOSYN II 8.5% (Brand Name Drug)
|
Company:
HOSPIRA
Active Ingredient(s):
AMINO ACIDS
FDA#:
(NDA) 019438
Review:
S Standard review drug
|
(Unrated) |
ACTIFED (Brand Name Drug)
|
Company:
GLAXOSMITHKLINE
Active Ingredient(s):
PSEUDOEPHEDRINE HYDROCHLORIDE; TRIPROLIDINE HYDROCHLORIDE
FDA#:
(NDA) 018996
Review:
S Standard review drug
|
(Unrated) |
RID MOUSSE (Brand Name Drug)
|
Company:
PFIZER
Active Ingredient(s):
PIPERONYL BUTOXIDE; PYRETHRINS
FDA#:
(NDA) 021043
Review:
S Standard review drug
|
(Unrated) |
LINCOMYCIN HYDROCHLORIDE (Generic Drug)
|
Company:
WATSON LABS
Active Ingredient(s):
LINCOMYCIN HYDROCHLORIDE
FDA#:
(ANDA) 063180
|
(Unrated) |
RABEPRAZOLE SODIUM (Generic Drug)
|
Company:
TEVA
Active Ingredient(s):
RABEPRAZOLE SODIUM
FDA#:
(ANDA) 076822
|
(Unrated) |
VYTORIN (Brand Name Drug)
|
Company:
MSP SINGAPORE
Active Ingredient(s):
EZETIMIBE; SIMVASTATIN
FDA#:
(NDA) 021687
Review:
S Standard review drug
|
(Unrated) |
TRAZODONE HYDROCHLORIDE
|
Company:
TRAZODONE HYDROCHLORIDE
(ANDA # 070491)
Active Ingredient(s):
• TRAZODONE HYDROCHLORIDE
|
(Unrated) |
MINOCIN
|
Company:
MINOCIN
(NDA # 050315)
Active Ingredient(s):
• MINOCYCLINE HYDROCHLORIDE
|
(Unrated) |
ADVIL MIGRAINE LIQUI-GELS (Brand Name Drug)
|
Company:
WYETH CONS
Active Ingredient(s):
IBUPROFEN
FDA#:
(NDA) 020402
Review:
S Standard review drug
|
(Unrated) |
PERIACTIN
|
Company:
PERIACTIN
(NDA # 012649)
Active Ingredient(s):
• CYPROHEPTADINE HYDROCHLORIDE
|
(Unrated) |
POTASSIUM CHLORIDE 0.224% IN SODIUM CHLORIDE 0.9% (Brand Name Drug)
|
Company:
BAXTER HLTHCARE
Active Ingredient(s):
POTASSIUM CHLORIDE; SODIUM CHLORIDE
FDA#:
(NDA) 017648
Review:
S Standard review drug
|
(Unrated) |
CHROMITOPE SODIUM (Brand Name Drug)
|
Company:
BRACCO
Active Ingredient(s):
SODIUM CHROMATE, CR-51
FDA#:
(NDA) 013993
Review:
S Standard review drug
|
(Unrated) |
MPI KRYPTON 81M GENERATOR (Brand Name Drug)
|
Company:
GE HEALTHCARE
Active Ingredient(s):
KRYPTON, KR-81M
FDA#:
(NDA) 018088
Review:
P Priority review drug
|
(Unrated) |
FLUORINE F-18 (Brand Name Drug)
|
Company:
GE HEALTHCARE
Active Ingredient(s):
SODIUM FLUORIDE, F-18
FDA#:
(NDA) 017042
Review:
P Priority review drug
|
(Unrated) |
AUREOMYCIN (Brand Name Drug)
|
Company:
LEDERLE
Active Ingredient(s):
CHLORTETRACYCLINE HYDROCHLORIDE
FDA#:
(NDA) 050404
|
(Unrated) |
BLOCADREN (Brand Name Drug)
|
Company:
MERCK
Active Ingredient(s):
TIMOLOL MALEATE
FDA#:
(NDA) 018017
Review:
P Priority review drug
|
(Unrated) |
EPIDUO (Brand Name Drug)
|
Company:
GALDERMA LABS LP
Active Ingredient(s):
ADAPALENE; BENZOYL PEROXIDE
FDA#:
(NDA) 022320
Review:
S Standard review drug
|
(Unrated) |
HEPATOLITE (Brand Name Drug)
|
Company:
PHARMALUCENCE
Active Ingredient(s):
TECHNETIUM TC-99M DISOFENIN KIT
FDA#:
(NDA) 018467
Review:
P Priority review drug
|
(Unrated) |
NICORETTE (MINT)
|
Company:
NICORETTE (MINT)
(NDA # 018612)
Active Ingredient(s):
• NICOTINE POLACRILEX
|
(Unrated) |
SELZENTRY (Brand Name Drug)
|
Company:
PFIZER
Active Ingredient(s):
MARAVIROC
FDA#:
(NDA) 022128
Review:
P Priority review drug
|
(Unrated) |
MEDIHALER-EPI (Brand Name Drug)
|
Company:
3M
Active Ingredient(s):
EPINEPHRINE BITARTRATE
FDA#:
(NDA) 010374
|
(Unrated) |
MIDAZOLAM HYDROCHLORIDE
|
Company:
MIDAZOLAM HYDROCHLORIDE
(ANDA # 075154)
Active Ingredient(s):
• MIDAZOLAM HYDROCHLORIDE
|
(Unrated) |
SODIUM BUTABARBITAL
|
Company:
SODIUM BUTABARBITAL
(ANDA # 083484)
Active Ingredient(s):
• BUTABARBITAL SODIUM
|
(Unrated) |
INOCOR (Brand Name Drug)
|
Company:
SANOFI AVENTIS US
Active Ingredient(s):
INAMRINONE LACTATE
FDA#:
(NDA) 018700
Review:
S Standard review drug
|
(Unrated) |
CARDURA XL (Brand Name Drug)
|
Company:
PFIZER
Active Ingredient(s):
DOXAZOSIN MESYLATE
FDA#:
(NDA) 021269
Review:
S Standard review drug
|
(Unrated) |
PHENAPHEN W/ CODEINE NO. 3 (Generic Drug)
|
Company:
ROBINS AH
Active Ingredient(s):
ACETAMINOPHEN; CODEINE PHOSPHATE
FDA#:
(ANDA) 084445
|
(Unrated) |
NORDITROPIN NORDIFLEX (Brand Name Drug)
|
Company:
NOVO NORDISK INC
Active Ingredient(s):
SOMATROPIN RECOMBINANT
FDA#:
(NDA) 021148
Review:
S Standard review drug
|
(Unrated) |
GYNE-LOTRIMIN COMBINATION PACK (Brand Name Drug)
|
Company:
SCHERING PLOUGH
Active Ingredient(s):
CLOTRIMAZOLE
FDA#:
(NDA) 020289
Review:
S Standard review drug
|
(Unrated) |
UROVIST SODIUM 300 (Generic Drug)
|
Company:
BAYER HLTHCARE
Active Ingredient(s):
DIATRIZOATE SODIUM
FDA#:
(ANDA) 087725
|
(Unrated) |
LOTEMAX
|
Company:
LOTEMAX
(NDA # 020583)
Active Ingredient(s):
• LOTEPREDNOL ETABONATE
|
(Unrated) |
CETAMIDE (Generic Drug)
|
Company:
ALCON
Active Ingredient(s):
SULFACETAMIDE SODIUM
FDA#:
(ANDA) 080021
|
(Unrated) |
ESTROPIPATE
|
Company:
ESTROPIPATE
(ANDA # 040135)
Active Ingredient(s):
• ESTROPIPATE
|
(Unrated) |
PAPA-DEINE #4 (Generic Drug)
|
Company:
VANGARD
Active Ingredient(s):
ACETAMINOPHEN; CODEINE PHOSPHATE
FDA#:
(ANDA) 088715
|
(Unrated) |
MONISTAT 5 (Brand Name Drug)
|
Company:
PERSONAL PRODS
Active Ingredient(s):
MICONAZOLE NITRATE
FDA#:
(NDA) 018592
Review:
S Standard review drug
|
(Unrated) |
DIALYTE W/ DEXTROSE 4.25% IN PLASTIC CONTAINER (Brand Name Drug)
|
Company:
B BRAUN
Active Ingredient(s):
CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE
FDA#:
(NDA) 018460
Review:
S Standard review drug
|
(Unrated) |
VELCADE (Brand Name Drug)
|
Company:
MILLENNIUM PHARMS
Active Ingredient(s):
BORTEZOMIB
FDA#:
(NDA) 021602
Review:
P Priority review drug
O Orphan drug
|
(Unrated) |
LONITEN (Brand Name Drug)
|
Company:
PHARMACIA AND UPJOHN
Active Ingredient(s):
MINOXIDIL
FDA#:
(NDA) 018154
Review:
P Priority review drug
|
(Unrated) |
HYDRAMINE
|
Company:
HYDRAMINE
(ANDA # 070205)
Active Ingredient(s):
• DIPHENHYDRAMINE HYDROCHLORIDE
|
(Unrated) |
AEROBID (Brand Name Drug)
|
Company:
ROCHE PALO
Active Ingredient(s):
FLUNISOLIDE
FDA#:
(NDA) 018340
Review:
S Standard review drug
|
(Unrated) |
AMITRIL
|
Company:
AMITRIL
(ANDA # 083937)
Active Ingredient(s):
• AMITRIPTYLINE HYDROCHLORIDE
|
(Unrated) |
DERMATOP (Brand Name Drug)
|
Company:
SANOFI AVENTIS US
Active Ingredient(s):
PREDNICARBATE
FDA#:
(NDA) 019568
Review:
S Standard review drug
|
(Unrated) |
MIXTARD HUMAN 70/30 (Brand Name Drug)
|
Company:
BAYER PHARMS
Active Ingredient(s):
INSULIN RECOMBINANT PURIFIED HUMAN; INSULIN SUSP ISOPHANE SEMISYNTHETIC PURIFIED HUMAN
FDA#:
(NDA) 019585
Review:
S Standard review drug
|
(Unrated) |
MICONAZOLE NITRATE
|
Company:
MICONAZOLE NITRATE
(ANDA # 073507)
Active Ingredient(s):
• MICONAZOLE NITRATE
|
(Unrated) |
OPTIMARK IN PLASTIC CONTAINER (Brand Name Drug)
|
Company:
MALLINCKRODT
Active Ingredient(s):
GADOVERSETAMIDE
FDA#:
(NDA) 020976
Review:
S Standard review drug
|
(Unrated) |
HEPARIN LOCK FLUSH IN PLASTIC CONTAINER (Brand Name Drug)
|
Company:
HOSPIRA
Active Ingredient(s):
HEPARIN SODIUM
FDA#:
(NDA) 005264
Review:
S Standard review drug
|
(Unrated) |
REVLIMID (Brand Name Drug)
|
Company:
CELGENE
Active Ingredient(s):
LENALIDOMIDE
FDA#:
(NDA) 021880
Review:
P Priority review drug
O Orphan drug
|
(Unrated) |
STAVUDIINE; LAMIVUDINE W/NEVIRAPINE (Brand Name Drug)
|
Company:
STRIDES ACROLAB
Active Ingredient(s):
STAVUDIINE; LAMIVUDINE W/NEVIRAPINE
FDA#:
(NDA) 021854
|
(Unrated) |
ATENOLOL
|
Company:
ATENOLOL
(ANDA # 072303)
Active Ingredient(s):
• ATENOLOL
|
(Unrated) |
IRESSA (Brand Name Drug)
|
Company:
ASTRAZENECA
Active Ingredient(s):
GEFITINIB
FDA#:
(NDA) 021399
Review:
P Priority review drug
|
(Unrated) |
X-TROZINE L.A. (Generic Drug)
|
Company:
SHIRE RICHWOOD
Active Ingredient(s):
PHENDIMETRAZINE TARTRATE
FDA#:
(ANDA) 087371
|
(Unrated) |
TENEX (Brand Name Drug)
|
Company:
PROMIUS PHARMA
Active Ingredient(s):
GUANFACINE HYDROCHLORIDE
FDA#:
(NDA) 019032
Review:
S Standard review drug
|
(Unrated) |
MICROSUL (Generic Drug)
|
Company:
FOREST PHARMS
Active Ingredient(s):
SULFAMETHIZOLE
FDA#:
(ANDA) 086012
|
(Unrated) |
AKRINOL (Brand Name Drug)
|
Company:
SCHERING
Active Ingredient(s):
ACRISORCIN
FDA#:
(NDA) 012470
Review:
S Standard review drug
|
(Unrated) |
NEO-DELTA-CORTEF
|
Company:
NEO-DELTA-CORTEF
(ANDA # 061037)
Active Ingredient(s):
• NEOMYCIN SULFATE; PREDNISOLONE ACETATE
|
(Unrated) |
MD-60 (Generic Drug)
|
Company:
MALLINCKRODT
Active Ingredient(s):
DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM
FDA#:
(ANDA) 087074
|
(Unrated) |
STILBETIN (Brand Name Drug)
|
Company:
BRISTOL MYERS SQUIBB
Active Ingredient(s):
DIETHYLSTILBESTROL
FDA#:
(NDA) 004056
|
(Unrated) |
INDOMETHACIN
|
Company:
INDOMETHACIN
(NDA # 018690)
Active Ingredient(s):
• INDOMETHACIN
|
(Unrated) |
HYDROPANE (Generic Drug)
|
Company:
HALSEY
Active Ingredient(s):
HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE
FDA#:
(ANDA) 088066
|
 |
AMOXIL
|
Company:
AMOXIL
(NDA # 050459)
Active Ingredient(s):
• AMOXICILLIN
|
(Unrated) |
IONOSOL T AND DEXTROSE 5% IN PLASTIC CONTAINER (Brand Name Drug)
|
Company:
HOSPIRA
Active Ingredient(s):
DEXTROSE; POTASSIUM CHLORIDE; POTASSIUM LACTATE; SODIUM CHLORIDE; SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS
FDA#:
(NDA) 019514
Review:
S Standard review drug
|
(Unrated) |
CELEBREX
|
Company:
CELEBREX
(NDA # 020998)
Active Ingredient(s):
• CELECOXIB
|
(Unrated) |
BUSPIRONE HYDROCHLORIDE
|
Company:
BUSPIRONE HYDROCHLORIDE
(ANDA # 074253)
Active Ingredient(s):
• BUSPIRONE HYDROCHLORIDE
|
(Unrated) |
HEPTALAC (Generic Drug)
|
Company:
TEVA PHARMS
Active Ingredient(s):
LACTULOSE
FDA#:
(ANDA) 073504
|
(Unrated) |
DRONABINOL (Generic Drug)
|
Company:
PAR PHARM
Active Ingredient(s):
DRONABINOL
FDA#:
(ANDA) 078292
|
(Unrated) |
RENOVA
|
Company:
RENOVA
(NDA # 019963)
Active Ingredient(s):
• TRETINOIN
|
(Unrated) |
PLETAL (Brand Name Drug)
|
Company:
OTSUKA
Active Ingredient(s):
CILOSTAZOL
FDA#:
(NDA) 020863
Review:
S Standard review drug
|
(Unrated) |
SINEMET (Brand Name Drug)
|
Company:
BRISTOL MYERS SQUIBB
Active Ingredient(s):
CARBIDOPA; LEVODOPA
FDA#:
(NDA) 017555
Review:
P Priority review drug
|
(Unrated) |
UNIPHYL
|
Company:
UNIPHYL
(ANDA # 040086)
Active Ingredient(s):
• THEOPHYLLINE
|
 |
ZIPAN-50 (Generic Drug)
|
Company:
ALTANA
Active Ingredient(s):
PROMETHAZINE HYDROCHLORIDE
FDA#:
(ANDA) 083997
|
