What's New on the FDA Drugs Site
December 31, 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) 4100.1 CDER Co-Sponsorship Agreements for Events (PDF - 565KB)
- National Drug Code Directory
New and Generic Drug Approvals
December 30, 2014
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Aplenzin | bupropion hydrobromide | Tablet, Extended Release;Oral | Valeant Bermuda | Labeling Revision |
| Lamictal | lamotrigine | Tablet;Oral | Glaxosmithkline Llc | Labeling Revision |
| Lamictal CD | lamotrigine | Tablet, Chewable;Oral | Glaxosmithkline Llc | Labeling Revision |
| Lamictal ODT | lamotrigine | Tablet, Orally Disintegrating;Oral | Glaxosmithkline Llc | Labeling Revision |
| Lamictal XR | lamotrigine | Tablet, Extended Release;Oral | Glaxosmithkline Llc | Labeling Revision |
| Natroba | spinosad | Suspension;Topical | Parapro Llc | Efficacy Supplement with Clinical Data to Support |
| Wellbutrin XL | bupropion hydrochloride | Tablet, Extended Release;Oral | Valeant Intl | Labeling Revision |
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