Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075624
Company: RISING
Company: RISING
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE | ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE | 5MG;12.5MG | TABLET;ORAL | Discontinued | None | No | No |
| ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE | ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE | 10MG;25MG | 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 |
|---|---|---|---|---|---|---|---|
| 09/18/2001 | ORIG-1 | Approval |
Letter (PDF)
Letter (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75624.ap.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75624ta.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 04/21/2020 | SUPPL-26 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/26/2016 | SUPPL-24 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/26/2016 | SUPPL-23 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/11/2014 | SUPPL-20 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/19/2011 | SUPPL-18 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/31/2011 | SUPPL-17 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
| 06/06/2003 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 09/05/2002 | SUPPL-1 | Labeling |
Label is not available on this site. |