New and Generic Drug Approvals
November 25, 2014
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Amoxil | amoxicillin | For Suspension;Oral | Dr Reddys Labs Inc | Labeling Revision |
| Bupropion Hydrochloride | bupropion hydrochloride | Tablet, Extended Release;Oral | Sandoz | Labeling Revision |
| Bupropion Hydrochloride | bupropion hydrochloride | Tablet;Oral | Apotex Inc | Labeling Revision |
| Bupropion Hydrochloride | bupropion hydrochloride | Tablet, Extended Release;Oral | Sun Pharma Global | Labeling Revision |
| Bupropion Hydrochloride | bupropion hydrochloride | Tablet, Extended Release;Oral | Actavis Labs Fl Inc | Labeling Revision |
| Bupropion Hydrochloride | bupropion hydrochloride | Tablet, Extended Release;Oral | Mylan | Labeling Revision |
| Bupropion Hydrochloride | bupropion hydrochloride | Tablet, Extended Release;Oral | Anchen Pharms | Labeling Revision |
| Bupropion Hydrochloride | bupropion hydrochloride | Tablet, Extended Release;Oral | Zydus Pharms Usa Inc | Labeling Revision |
| Bupropion Hydrochloride | bupropion hydrochloride | Tablet, Extended Release;Oral | Jubilant Generics | Labeling Revision |
| Divalproex Sodium | divalproex sodium | Tablet, Extended Release;Oral | Reddys | Labeling Revision |
| Divalproex Sodium | divalproex sodium | Tablet, Delayed Release;Oral | Aurobindo Pharma Ltd | Labeling Revision |
| Divalproex Sodium | divalproex sodium | Tablet, Extended Release;Oral | Aurobindo Pharma Ltd | Labeling Revision |
| Larotid | amoxicillin | For Suspension;Oral | Dr Reddys Labs Inc | Labeling Revision |
| Lucentis | ranibizumab | Injectable; Injection | Genentech | Efficacy Supplement with Clinical Data to Support |
| Norco | acetaminophen; hydrocodone bitartrate | Tablet;Oral | Watson Labs | Labeling Revision |
| Priftin | rifapentine | Tablet;Oral | Sanofi Aventis Us | Efficacy Supplement with Clinical Data to Support |
| Topiramate | topiramate | Capsule;Oral | Zydus Pharms Usa Inc | Labeling Revision |
| Tussicaps | chlorpheniramine polistirex; hydrocodone polistirex | Capsule, Extended Release;Oral | Ecr Pharma | Labeling Revision |
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