Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075583
Company: APOTHECON
Company: APOTHECON
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ENALAPRIL MALEATE | ENALAPRIL MALEATE | 2.5MG | TABLET;ORAL | Discontinued | None | No | No |
ENALAPRIL MALEATE | ENALAPRIL MALEATE | 5MG | TABLET;ORAL | Discontinued | None | No | No |
ENALAPRIL MALEATE | ENALAPRIL MALEATE | 10MG | TABLET;ORAL | Discontinued | None | No | No |
ENALAPRIL MALEATE | ENALAPRIL MALEATE | 20MG | 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 |
---|---|---|---|---|---|---|---|
08/22/2000 | ORIG-1 | Approval |
Letter (PDF)
Letter (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75523LTR.PDF https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75583ta.pdf |