Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 074576
Company: WATSON LABS
Company: WATSON LABS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CAPTOPRIL | CAPTOPRIL | 12.5MG | TABLET;ORAL | Discontinued | None | No | No |
| CAPTOPRIL | CAPTOPRIL | 25MG | TABLET;ORAL | Discontinued | None | No | No |
| CAPTOPRIL | CAPTOPRIL | 50MG | TABLET;ORAL | Discontinued | None | No | No |
| CAPTOPRIL | CAPTOPRIL | 100MG | 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 |
|---|---|---|---|---|---|---|---|
| 04/23/1996 | 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 |
|---|---|---|---|---|---|
| 04/06/1998 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 07/11/1997 | SUPPL-4 | Labeling |
Label is not available on this site. |
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| 10/30/1997 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/30/1997 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/30/1997 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |