New and Generic Drug Approvals
October 28, 2014
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Adapalene | adapalene | Gel; Topical | Actavis Mid Atlantic | Approval |
| Carisoprodol | carisoprodol | Tablet;Oral | Natco Pharma Ltd | Approval |
| Darunavir Ethanolate | darunavir ethanolate | Tablet;Oral | Hetero Labs Unit Iii | Tentative Approval |
| Hydrocodone Bitartrate; Pseudoephedrine Hydrochloride | hydrocodone bitartrate;pseudoephedrine hydrochloride | Solution;Oral | Tris Pharma Inc | Approval |
| Idkit:hp | citric acid; urea c-13 | For Solution, Tablet, For Solution;Oral | Exalenz Bioscience | Labeling Revision |
| Maraviroc | maraviroc | Tablet;Oral | Hetero Labs Unit Iii | Tentative Approval |
| Metoprolol Tartrate | metoprolol tartrate | Tablet;Oral | Rubicon Research Pvt Ltd | Approval |
| Nicardipine Hydrochloride | nicardipine hydrochloride | Injectable;Injection | Exela Pharma Science | Manufacturing Change or Addition |
| Quetiapine Fumarate | quetiapine fumarate | Tablet;Oral | Alembic Pharms Ltd | Approval |
| Sirolimus | sirolimus | Tablet; Oral | Dr Reddys Labs Ltd | Approval |
| Somatuline Depot | lanreotide acetate | Injectable;Subcutaneous | Ipsen Pharma | Manufacturing Change or Addition |
| Soriatane | acitretin | Capsule;Oral | Stiefel Labs Inc | Manufacturing Change or Addition |
| Vibramycin | doxycycline hyclate | Capsule;Oral | Pfizer | Manufacturing Change or Addition |
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