What's New on the FDA Drugs Site
November 19, 2014
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- Drugs@FDA Data Files (updated)
- Manual of Policies and Procedures (MAPP) Chemistry Review of Question-based Review (QbR) Submissions (PDF - 753KB)
- National Drug Code Directory
- Postmarket Requirements and Commitments Search (updated)
New and Generic Drug Approvals
November 18, 2014
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Children's Fexofenadine Hydrochloride Allergy | fexofenadine hydrochloride | Suspension;Oral | Actavis Mid Atlantic | Approval |
| Children's Fexofenadine Hydrochloride Hives | fexofenadine hydrochloride | Suspension;Oral | Actavis Mid Atlantic | Approval |
| Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride | fexofenadine hydrochloride; pseudoephedrine hydrochloride | Tablet, Extended Release;Oral | Dr Reddys Labs Ltd | Approval |
| Fexofenadine Hydrochloride; Pseudoephedrine Hydrochloride | fexofenadine hydrochloride; pseudoephedrine hydrochloride | Tablet, Extended Release;Oral | Dr Reddys Labs Ltd | Approval |
| Paricalcitol | paricalcitol | Injectable;Injection | Hikma | Approval |
| Saphris | asenapine maleate | Tablet;Sublingual | Forest Labs Inc | Labeling Revision |
| Votrient | pazopanib hydrochloride | Tablet;Oral | Glaxosmithkline | Efficacy Supplement with Clinical Data to Support |
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Thursday, November 20, 2014
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