Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 214328
Company: RK PHARMA
Company: RK PHARMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
CARBAMAZEPINE | CARBAMAZEPINE | 200MG | 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 |
---|---|---|---|---|---|---|---|
08/16/2021 | ORIG-1 | Approval | STANDARD |
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