Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 209156
Company: JUBILANT GENERICS
Company: JUBILANT GENERICS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
NIACIN | NIACIN | 500MG | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | No | No |
NIACIN | NIACIN | 750MG | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | No | No |
NIACIN | NIACIN | 1GM | 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 |
---|---|---|---|---|---|---|---|
05/14/2018 | ORIG-1 | Approval | STANDARD |
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