Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 070625
Company: WATSON LABS
Company: WATSON LABS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| METHYLDOPA | METHYLDOPA | 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 |
|---|---|---|---|---|---|---|---|
| 06/06/1986 | 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 |
|---|---|---|---|---|---|
| 05/12/1999 | SUPPL-23 | Labeling |
Label is not available on this site. |
||
| 06/11/1998 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
| 09/27/1996 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
| 08/25/1993 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 06/22/1993 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
| 11/16/1993 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/16/1993 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 11/16/1993 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/04/1991 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 01/28/1991 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/07/1991 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/29/1990 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/01/1989 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 08/09/1989 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/06/1989 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/26/1988 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/10/1988 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/09/1988 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 06/13/1988 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |