Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 090463
Company: APOTEX
Company: APOTEX
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
PERINDOPRIL ERBUMINE | PERINDOPRIL ERBUMINE | 2MG | TABLET;ORAL | Discontinued | None | No | No |
PERINDOPRIL ERBUMINE | PERINDOPRIL ERBUMINE | 4MG | TABLET;ORAL | Discontinued | None | No | No |
PERINDOPRIL ERBUMINE | PERINDOPRIL ERBUMINE | 8MG | 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 |
---|---|---|---|---|---|---|---|
08/30/2010 | 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 |
---|---|---|---|---|---|
04/15/2015 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |