What's New on the FDA Drugs Site
July 24, 2014
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- FDA Drug Shortages: New and Updated
- Methylphenidate Hydrochloride ER Capsules/Tablets (Currently in Shortage)
- National Drug Code Directory
New and Generic Drug Approvals
July 23, 2014
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Cardene | nicardipine hydrochloride | Injectable;Injection | Chiesi Usa Inc | Labeling Revision |
| Cardene In 0.83% Sodium Chloride In Plastic Container | nicardipine hydrochloride | Injectable;Intravenous | Chiesi Usa Inc | Labeling Revision |
| Cardene In 0.86% Sodium Chloride In Plastic Container | nicardipine hydrochloride | Injectable;Intravenous | Chiesi Usa Inc | Labeling Revision |
| Cardene In 4.8% Dextrose In Plastic Container | nicardipine hydrochloride | Injectable;Intravenous | Chiesi Usa Inc | Labeling Revision |
| Cardene In 5.0% Dextrose In Plastic Container | nicardipine hydrochloride | Injectable;Intravenous | Chiesi Usa Inc | Labeling Revision |
| Edarbi | azilsartan kamedoxomil | Tablet;Oral | Arbor Pharms Ireland | Labeling Revision |
| Edarbyclor | azilsartan kamedoxomil; chlorthalidone | Tablet;Oral | Arbor Pharms Ireland | Labeling Revision |
| Hydrochlorothiazide | hydrochlorothiazide | Tablet;Oral | Sciegen Pharms Inc | Approval |
| Targiniq Er | oxycodone hydrochloride;naloxone hydrochloride | Tablet, Extended Release;Oral | Purdue Frederick | Approval |
| Terazol 3 | terconazole | Suppository;Vaginal | Janssen Pharms | Labeling Revision |
| Terazol 3 | terconazole | Cream;Vaginal | Janssen Pharms | Labeling Revision |
| Terazol 7 | terconazole | Cream;Vaginal | Janssen Pharms | Labeling Revision |
| Testosterone | testosterone | Gel;Transdermal | Teva Pharms | Labeling Revision |
| Zydelig | idelalisib | Tablet;Oral | Gilead Sciences Inc | Approval |
| Zydelig | idelalisib | Tablet;Oral | Gilead Sciences Inc | Approval |
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