What's New on the FDA Drugs Site
July 25, 2013
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Reviews (FDASIA) (updated)
- National Drug Code Directory
New and Generic Drug Approvals
July 24, 2013
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Cellcept | mycophenolate mofetil | Suspension; Oral | Roche Palo | Manufacturing Change or Addition |
| Donepezil Hydrochloride | donepezil hydrochloride | Tablet; Oral | Par Pharm | Approval |
| Donepezil Hydrochloride | donepezil hydrochloride | Tablet; Oral | Macleods Pharma | Tentative Approval |
| Donepezil Hydrochloride | donepezil hydrochloride | Tablet; Oral | Dr Reddys Labs Ltd | Approval |
| Invanz | ertapenem sodium | Injectable; Intramuscular, Iv (Infusion) | Merck Sharp Dohme | Labeling Revision |
| Lo Minastrin Fe | norethindrone acetate; ethinyl estradiol; ethinyl estradiol; ferrous fumarate | Tablet, Chewable, Tablet; Oral | Warner Chilcott Llc | Approval |
| Norvasc | amlodipine besylate | Tablet; Oral | Pfizer | Manufacturing Change or Addition |
| Pediatric Advil | ibuprofen | Suspension/Drops; Oral | Pfizer | Manufacturing Change or Addition |
| Viread | tenofovir disoproxil fumarate | Tablet; Oral | Gilead Sciences Inc | Efficacy Supplement with Clinical Data to Support |
| Viread | tenofovir disoproxil fumarate | Powder; Oral | Gilead Sciences Inc | Efficacy Supplement with Clinical Data to Support |
| Zingo | lidocaine hydrochloride | System; Intradermal | Powder Pharms | Manufacturing Change or Addition |
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