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From: U.S. Food & Drug Administration (FDA) <fda@service.govdelivery.com>
Date: Thu, Jul 31, 2014 at 6:21 AM
Subject: CDER New July 31, 2014
To: iammejtm@gmail.com
From: U.S. Food & Drug Administration (FDA) <fda@service.govdelivery.com>
Date: Thu, Jul 31, 2014 at 6:21 AM
Subject: CDER New July 31, 2014
To: iammejtm@gmail.com
What's New on the FDA Drugs Site
July 30, 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) 4130.1 Drug Development Tool Qualification Programs (PDF - 275KB)
- National Drug Code Directory
New and Generic Drug Approvals
July 29, 2014
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Dextromethorphan Hydrobromide and Quinidine Sulfate | dextromethorphan hydrobromide;quinidine sulfate | Capsule;Oral | Par Pharm Inc | Tentative Approval |
| Epinephrine | epinephrine | Injectable;Injection | Belcher Pharms | Approval |
| Kalydeco | ivacaftor | Tablet;Oral | Vertex Pharms | Manufacturing Change or Addition |
| Korlym | mifepristone | Tablet;Oral | Corcept Therap | Manufacturing Change or Addition |
| Natrecor | nesiritide recombinant | For Solution;Intravenous | Scios Llc | Manufacturing Change or Addition |
| Prandimet | metformin hydrochloride; repaglinide | Tablet;Oral | Novo Nordisk Inc | Manufacturing Change or Addition |
| Viokace | pancrelipase (amylase;lipase;protease) | Tablet;Oral | Forest Labs Inc | Manufacturing Change or Addition |
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Jeremy Tobias Matthews
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