September Drug Approvals ABRAXANE (NDA #
Post# of 63700
Posted On: 09/06/2013 5:28:23 PM
Re: StocksDiva #15039
September Drug Approvals
| ABRAXANE (NDA # 021660) | 037 | PACLITAXEL | ABRAXIS BIOSCIENCE | New or Modified Indication | 09/06/2013 |
| JENTADUETO (NDA # 201281) | 004 | LINAGLIPTIN; METFORMIN HYDROCHLORIDE | BOEHRINGER INGELHEIM | Efficacy Supplement with Clinical Data to Support | 09/05/2013 |
| GEMCITABINE HYDROCHLORIDE (NDA # 200795) | 004 | GEMCITABINE HYDROCHLORIDE | HOSPIRA INC | Labeling Revision | 09/05/2013 |
| COPAXONE (NDA # 020622) | 085 | GLATIRAMER ACETATE | TEVA PHARMS USA | Manufacturing Change or Addition | 09/05/2013 |
| NIZORAL A-D (NDA # 020310) | 020 | KETOCONAZOLE | MCNEIL CONS | Manufacturing Change or Addition | 09/05/2013 |
| LIORESAL (NDA # 020075) | 027 | BACLOFEN | MEDTRONIC | Manufacturing Change or Addition | 09/05/2013 |
| IONOSOL B AND DEXTROSE 5% IN PLASTIC CONTAINER (NDA # 019515) | 033 | DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE; SODIUM LACTATE; SODIUM PHOSPHATE, MONOBASIC ANHYDROUS | HOSPIRA | Manufacturing Change or Addition | 09/05/2013 |
| ETHAMOLIN (NDA # 019357) | 020 | ETHANOLAMINE OLEATE | QOL MEDCL | Manufacturing Change or Addition | 09/05/2013 |
| STERILE WATER FOR INJECTION IN PLASTIC CONTAINER (NDA # 018233) | 080 | STERILE WATER FOR INJECTION | HOSPIRA | Manufacturing Change or Addition | 09/05/2013 |
| METOPIRONE (NDA # 012911) | 033 | METYRAPONE | HRA PHARMA | Manufacturing Change or Addition | 09/05/2013 |
| ZUBSOLV (NDA # 204242) | 002 | BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE | OREXO AB | Supplement | 09/04/2013 |
| PROGRAF (NDA # 050709) | 036 | TACROLIMUS | ASTELLAS | Labeling Revision | 09/04/2013 |
| VIBRAMYCIN (NDA # 050007) | 026 | DOXYCYCLINE HYCLATE | PFIZER | Labeling Revision | 09/04/2013 |
| MINIRIN (NDA # 021333) | 009 | DESMOPRESSIN ACETATE | FERRING | Manufacturing Change or Addition | 09/04/2013 |
| INFUVITE ADULT (NDA # 021163) | 025 | ALPHA-TOCOPHEROL ACETATE; ASCORBIC ACID; BIOTIN; CHOLECALCIFEROL; CYANOCOBALAMIN; DEXPANTHENOL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN 5'-PHOSPHATE SODIUM; THIAMINE HYDROCHLORIDE; VITAMIN A PALMITATE; VITAMIN K | SANDOZ | Manufacturing Change or Addition | 09/04/2013 |
| LATUDA (NDA # 200603) | 016 | LURASIDONE HYDROCHLORIDE | SUNOVION PHARMS INC | Labeling Revision | 09/03/2013 |
| FYCOMPA (NDA # 202834) | 002 | PERAMPANEL | EISAI INC | Manufacturing Change or Addition | 09/02/2013 |
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