Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 074827
Company: COSETTE
Company: COSETTE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CAPTOPRIL AND HYDROCHLOROTHIAZIDE | CAPTOPRIL; HYDROCHLOROTHIAZIDE | 25MG;15MG | TABLET;ORAL | Discontinued | None | No | No |
| CAPTOPRIL AND HYDROCHLOROTHIAZIDE | CAPTOPRIL; HYDROCHLOROTHIAZIDE | 25MG;25MG | TABLET;ORAL | Discontinued | None | No | No |
| CAPTOPRIL AND HYDROCHLOROTHIAZIDE | CAPTOPRIL; HYDROCHLOROTHIAZIDE | 50MG;25MG | TABLET;ORAL | Discontinued | None | No | No |
| CAPTOPRIL AND HYDROCHLOROTHIAZIDE | CAPTOPRIL; HYDROCHLOROTHIAZIDE | 50MG;15MG | 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 |
|---|---|---|---|---|---|---|---|
| 12/29/1997 | 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 |
|---|---|---|---|---|---|
| 08/20/2020 | SUPPL-19 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/30/2009 | SUPPL-17 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/29/2006 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 08/30/2001 | SUPPL-4 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 05/15/2000 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 07/07/2000 | SUPPL-2 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 03/22/1999 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |