Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076116
Company: CHARTWELL RX
Company: CHARTWELL RX
| 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 |
|---|---|---|---|---|---|---|---|
| 09/19/2001 | 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 |
|---|---|---|---|---|---|
| 07/25/2025 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/11/2015 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/11/2015 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/11/2015 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/11/2015 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/12/2011 | SUPPL-7 | Labeling-Package Insert, Labeling-Package Insert |
Label is not available on this site. |
||
| 05/29/2003 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 09/05/2002 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 01/08/2002 | SUPPL-1 | Manufacturing (CMC)-Facility |
Label is not available on this site. |