What's New on the FDA Drugs Site
July 15, 2013
- Current Drug Shortages Index (updated)
- Drugs to be Discontinued (updated)
- Resolved Drugs (updated)
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- National Drug Code Directory
- Orange Book (updated)
New and Generic Drug Approvals
July 13, 2013
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Infuvite Adult | 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 | Injectable; Injection | Sandoz | Manufacturing Change or Addition |
July 12, 2013
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Azactam In Plastic Container | aztreonam | Injectable; Injection | Bristol Myers Squibb | Manufacturing Change or Addition |
| Bactrim | sulfamethoxazole; trimethoprim | Tablet; Oral | Mutual Pharm | Labeling Revision |
| Bactrim Ds | sulfamethoxazole; trimethoprim | Tablet; Oral | Mutual Pharm | Labeling Revision |
| Desogestrel; Ethinyl Estradiol | desogestrel; ethinyl estradiol | Tablet; Oral | Novast Labs Ltd | Approval |
| Fanapt | iloperidone | Tablet; Oral | Novartis | Manufacturing Change or Addition |
| Folic Acid | folic acid | Tablet; Oral | Bicon Pharmaceutical Inc | Approval |
| Gabapentin | gabapentin | Tablet; Oral | Allied Pharma Inc | Approval |
| Gilotrif | afatinib | Tablet; Oral | Boehringer Ingelheim | Approval |
| Latuda | lurasidone hydrochloride | Tablet; Oral | Sunovion Pharms Inc | Manufacturing Change or Addition |
| Mycophenolate Mofetil | mycophenolate mofetil | Capsule; Oral | Alkem Labs Ltd | Approval |
| Oxycodone Hydrochloride | oxycodone hydrochloride | Solution; Oral | Roxane | Approval |
| Rapaflo | silodosin | Capsule; Oral | Watson Labs | Labeling Revision |
| Tri-Luma | fluocinolone acetonide; hydroquinone; tretinoin | Cream; Topical | Galderma Labs Lp | Manufacturing Change or Addition |
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