---------- Forwarded message ----------
From: U.S. Food & Drug Administration (FDA) <fda@service.govdelivery.com>
Date: Wed, Jul 23, 2014 at 7:55 AM
Subject: CDER New July 23, 2014
To: iammejtm@gmail.com
From: U.S. Food & Drug Administration (FDA) <fda@service.govdelivery.com>
Date: Wed, Jul 23, 2014 at 7:55 AM
Subject: CDER New July 23, 2014
To: iammejtm@gmail.com
What's New on the FDA Drugs Site
July 22, 2014
- Public Notification: O.M.G. Contains Hidden Drug Ingredient
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- National Drug Code Directory
- Safe Use Initiative: Funding and Support (updated)
New and Generic Drug Approvals
July 21, 2014
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Brompheniramine Maleate;Pseudoephedrine Hcl;Dextromethorphan Hydrobromide | brompheniramine maleate;pseudoephedrine hcl;dextromethorphan hydrobromide | Syrup;Oral | Vintage Pharms | Approval |
| Fiorinal | aspirin; butalbital; caffeine | Capsule;Oral | Watson Labs Inc | Manufacturing Change or Addition |
| Fiorinal | aspirin; butalbital; caffeine | Tablet;Oral | Watson Labs Inc | Manufacturing Change or Addition |
| Pennsaid | diclofenac sodium | Solution;Topical | Mallinckrodt Inc | Manufacturing Change or Addition |
| Qvar 40 | beclomethasone dipropionate | Aerosol, Metered;Inhalation | Teva Branded Pharm | Labeling Revision |
| Qvar 80 | beclomethasone dipropionate | Aerosol, Metered;Inhalation | Teva Branded Pharm | Labeling Revision |
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Jeremy Tobias Matthews
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