Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 078320
Company: INVAGEN PHARMS
Company: INVAGEN PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
TRANDOLAPRIL | TRANDOLAPRIL | 1MG | TABLET;ORAL | Discontinued | None | No | No |
TRANDOLAPRIL | TRANDOLAPRIL | 2MG | TABLET;ORAL | Discontinued | None | No | No |
TRANDOLAPRIL | TRANDOLAPRIL | 4MG | 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 |
---|---|---|---|---|---|---|---|
06/12/2007 | 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 |
---|---|---|---|---|---|
06/10/2013 | SUPPL-1 | Labeling-Container/Carton Labels |
Label is not available on this site. |