Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 078138
Company: ANI PHARMS
Company: ANI PHARMS
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 |
---|---|---|---|---|---|---|---|
11/10/2009 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/078138s000ltr.pdf |