Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 204164
Company: JUBILANT GENERICS
Company: JUBILANT GENERICS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
TELMISARTAN | TELMISARTAN | 20MG | TABLET;ORAL | Discontinued | None | No | No |
TELMISARTAN | TELMISARTAN | 40MG | TABLET;ORAL | Discontinued | None | No | No |
TELMISARTAN | TELMISARTAN | 80MG | 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 |
---|---|---|---|---|---|---|---|
08/22/2016 | 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 |
---|---|---|---|---|---|
11/04/2019 | SUPPL-2 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |