Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 209739
Company: HIKMA
Company: HIKMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
TETRABENAZINE | TETRABENAZINE | 12.5MG | TABLET;ORAL | Discontinued | None | No | No |
TETRABENAZINE | TETRABENAZINE | 25MG | 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 |
---|---|---|---|---|---|---|---|
04/08/2019 | ORIG-1 | Approval | STANDARD |
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