What's New on the FDA Drugs Site
June 03, 2014
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- National Drug Code Directory
- Public Notification: GoldReallas Contains Hidden Drug Ingredient
- Public Notification: Full Throttle On Demand Contains Hidden Drug Ingredient
- Public Notification: 3 Hard Knights Contains Hidden Drug Ingredient
- Public Notification: Dick’s Hard Up Contains Hidden Drug Ingredient
- Public Notification: Liu Bian Li Contains Hidden Drug Ingredient
- Public Notification: Eyeful Contains Hidden Drug Ingredient
- Meeting Materials: Advancing the Development of Pediatri Therapeutics (ADEPT) Pediatric Bone Health
New and Generic Drug Approvals
June 2, 2014
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Divalproex Sodium | divalproex sodium | Tablet, Extended Release;Oral | Aurobindo Pharma Ltd | Approval |
| Dymista | azelastine hydrochloride; fluticasone propionate | Spray, Metered;Nasal | Meda Pharms | Manufacturing Change or Addition |
| Kyprolis | carfilzomib | Powder;Intravenous | Onyx Pharms | Manufacturing Change or Addition |
| Mefenamic Acid | mefenamic acid | Capsule;Oral | Vintage Pharms Llc | Approval |
| Methadose | methadone hydrochloride | Concentrate;Oral | Mallinckrodt | Manufacturing Change or Addition |
| Ms Contin | morphine sulfate | Tablet, Extended Release;Oral | Purdue Pharma Lp | Manufacturing Change or Addition |
| Oxycodone Hydrochloride | oxycodone hydrochloride | Capsule;Oral | Lehigh Valley | Manufacturing Change or Addition |
| Oxycodone Hydrochloride | oxycodone hydrochloride | Solution;Oral | Vistapharm | Manufacturing Change or Addition |
| Reyataz | atazanavir sulfate | Capsule;Oral | Bristol Myers Squibb | Efficacy Supplement with Clinical Data to Support |
| Reyataz | atazanavir | Powder;Oral | Bristol Myers Squibb | Approval |
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