Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 078483
Company: SYNTHON PHARMS
Company: SYNTHON PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ZOLPIDEM TARTRATE | ZOLPIDEM TARTRATE | 6.25MG | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | No | No |
ZOLPIDEM TARTRATE | ZOLPIDEM TARTRATE | 12.5MG | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | No | No |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
06/06/2011 | ORIG-2 | Approval |
Label is not available on this site. |
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04/12/2011 | ORIG-1 | Approval |
Label is not available on this site. |