New and Generic Drug Approvals
October 13, 2014
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Adrenaclick | epinephrine | Injectable;Intramuscular, Subcutaneous | Amedra Pharms | Manufacturing Change or Addition |
| Oxycontin | oxycodone hydrochloride | Tablet, Extended Release;Oral | Purdue Pharma Lp | Manufacturing Change or Addition |
| 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 |
| Valchlor | mechlorethamine hydrochloride | Gel;Topical | Actelion Pharms Ltd | Manufacturing Change or Addition |
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