What's New on the FDA Drugs Site
October 30, 2013
- Drug Firm Annual Registration Status (updated)
- Drugs@FDA Data Files (updated)
- National Drug Code Directory
New and Generic Drug Approvals
October 29, 2013
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Acyclovir | acyclovir | Tablet;Oral | Hetero Labs Ltd V | Approval |
| Clonidine Hydrochloride | clonidine hydrochloride | Injectable;Injection | Exela Pharma Scs Llc | Approval |
| Diovan | valsartan | Capsule;Oral | Novartis | Labeling Revision |
| Horizant | gabapentin enacarbil | Tablet, Extended Release;Oral | Xenoport Inc | Manufacturing Change or Addition |
| Lexiva | fosamprenavir calcium | Tablet;Oral | Viiv Hlthcare | Manufacturing Change or Addition |
| Nizoral | ketoconazole | Shampoo;Topical | Janssen Pharms | Labeling Revision |
| Seroquel | quetiapine fumarate | Tablet;Oral | Astrazeneca | Labeling Revision |
| Seroquel Xr | quetiapine fumarate | Tablet, Extended Release;Oral | Astrazeneca | Labeling Revision |
| Xylocaine | lidocaine hydrochloride | Injectable;Injection | Fresenius Kabi Usa | Manufacturing Change or Addition |
| Xylocaine W/ Epinephrine | epinephrine; lidocaine hydrochloride | Injectable;Injection | Fresenius Kabi Usa | Manufacturing Change or Addition |
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