Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075480
Company: AUROBINDO PHARMA USA
Company: AUROBINDO PHARMA USA
| 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/2000/75480ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75480ta.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 04/18/2016 | SUPPL-15 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/18/2016 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/23/2015 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/30/2011 | SUPPL-10 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
| 12/19/2002 | SUPPL-1 | Labeling |
Label is not available on this site. |