Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 071069
Company: WATSON LABS
Company: WATSON LABS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| METHYLDOPA AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; METHYLDOPA | 30MG;500MG | 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 |
|---|---|---|---|---|---|---|---|
| 01/19/1989 | 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 |
|---|---|---|---|---|---|
| 08/26/1998 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 10/08/1996 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 08/11/1993 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 05/06/1993 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 05/24/1991 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 03/19/1991 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 01/28/1991 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/07/1991 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/17/1989 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 04/29/1991 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/09/1989 | SUPPL-1 | Labeling |
Label is not available on this site. |