What's New on the FDA Drugs Site
March 25, 2014
- Current Drug Shortages Index (updated)
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- Expanded Access INDs and Protocols (Reports)
- National Drug Code Directory
New and Generic Drug Approvals
March 24, 2014
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Adenosine | adenosine | Injectable;Injection | Hospira Inc | Approval |
| Adrenaclick | epinephrine | Injectable;Intramuscular, Subcutaneous | Amedra Pharms | Manufacturing Change or Addition |
| Betamethasone Valerate | betamethasone valerate | Lotion;Topical | Fougera | Manufacturing Change or Addition |
| Bydureon | exenatide synthetic | For Suspension, Extended Release;Subcutaneous | Amylin | Manufacturing Change or Addition |
| Diflucan | fluconazole | Tablet;Oral | Pfizer | Labeling Revision |
| Diflucan | fluconazole | For Suspension;Oral | Pfizer | Labeling Revision |
| Diflucan In Dextrose 5% In Plastic Container | fluconazole | Injectable;Injection | Pfizer | Labeling Revision |
| Diflucan In Sodium Chloride 0.9% | fluconazole | Injectable;Injection | Pfizer | Labeling Revision |
| Diflucan In Sodium Chloride 0.9% In Plastic Container | fluconazole | Injectable;Injection | Pfizer | Labeling Revision |
| Fortesta | testosterone | Gel, Metered;Transdermal | Endo Pharms | Labeling Revision |
| Memantine Hydrochloride | memantine hydrochloride | Tablet; Oral | Aurobindo Pharma Ltd | Tentative Approval |
| Metronidazole | metronidazole | Gel;Vaginal | Valeant Pharms | Approval |
| Prevantics Maxi Swabstick | chlorhexidine gluconate; isopropyl alcohol | Swab;Topical | Prof Dspls | Labeling Revision |
| Prevantics Swab | chlorhexidine gluconate; isopropyl alcohol | Swab;Topical | Prof Dspls | Labeling Revision |
| Prevantics Swabstick | chlorhexidine gluconate; isopropyl alcohol | Swab;Topical | Prof Dspls | Labeling Revision |
| Twinject 0.15 | epinephrine | Injectable;Intramuscular, Subcutaneous | Amedra Pharms | Manufacturing Change or Addition |
| Twinject 0.3 | epinephrine | Injectable;Intramuscular, Subcutaneous | Amedra Pharms | Manufacturing Change or Addition |
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