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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