Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 078129
Company: HIKMA
Company: HIKMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ZOLPIDEM TARTRATE | ZOLPIDEM TARTRATE | 5MG | TABLET;ORAL | Discontinued | None | No | No |
ZOLPIDEM TARTRATE | ZOLPIDEM TARTRATE | 10MG | TABLET;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 |
---|---|---|---|---|---|---|---|
04/30/2008 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
09/13/2022 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
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03/20/2013 | SUPPL-3 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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09/03/2008 | SUPPL-1 | Labeling |
Label is not available on this site. |