What's New on the FDA Drugs Site
September 10, 2012
- Drug Firm Annual Registration Status Download File (updated)
- Drug Firm Annual Registration Status (updated)
- National Drug Code Directory (updated)
New and Generic Drug Approvals
September 7, 2012
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Aggrenox | aspirin; dipyridamole | Capsule, Extended Release; Oral | Boehringer Ingelheim | Labeling Revision |
| Androgel | testosterone | Gel, Metered; Transdermal | Abbott Labs | Labeling Revision |
| Clobex | clobetasol propionate | Spray; Topical | Galderma Labs Lp | Labeling Revision |
| Levofloxacin | levofloxacin | Tablet; Oral | Zydus Pharms Usa Inc | Approval |
| Multaq | dronedarone hydrochloride | Tablet; Oral | Sanofi Aventis Us | Efficacy Supplement with Clinical Data to Support |
| Multaq | dronedarone hydrochloride | Tablet; Oral | Sanofi Aventis Us | Labeling Revision |
| Ozurdex | dexamethasone | Implant; Intravitreal | Allergan | Labeling Revision |
| Xopenex | levalbuterol hydrochloride | Solution; Inhalation | Sunovion | Labeling Revision |
September 6, 2012
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Bicillin C-R | penicillin g benzathine; penicillin g procaine | Injectable; Injection | King Pharms | Labeling Revision |
| Bicillin C-R 900/300 | penicillin g benzathine; penicillin g procaine | Injectable; Injection | King Pharms | Labeling Revision |
| Bicillin L-A | penicillin g benzathine | Injectable; Injection | King Pharms | Labeling Revision |
| Cefepime and Dextrose In Duplex Container | cefepime hydrochloride | Injectable; Injection | B Braun | Labeling Revision |
| Cefepime In Plastic Container | cefepime hydrochloride | Injectable; Injection | Baxter Hlthcare | Labeling Revision |
| Leucovorin Calcium Preservative Free | leucovorin calcium | Injectable; Injection | Sagent Pharms | Approval |
| Leucovorin Calcium Preservative Free | leucovorin calcium | Injectable; Injection | Sagent Pharms | Approval |
| Maxipime | cefepime hydrochloride | Injectable; Injection | Hospira Inc | Labeling Revision |
| Tramadol Hydrochloride and Acetaminophen | acetaminophen; tramadol hydrochloride | Tablet; Oral | Zydus Pharms Usa Inc | Approval |
| Ventolin Hfa | albuterol sulfate | Aerosol, Metered; Inhalation | Glaxosmithkline | Labeling Revision |
| Xyzal | levocetirizine dihydrochloride | Tablet; Oral | Ucb Inc | Labeling Revision |
| Xyzal | levocetirizine dihydrochloride | Solution; Oral | Ucb Inc | Labeling Revision |
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