Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 070074
Company: SUN PHARM INDUSTRIES
Company: SUN PHARM INDUSTRIES
| 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 |
|---|---|---|---|---|---|---|---|
| 10/09/1986 | 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 |
|---|---|---|---|---|---|
| 08/05/1998 | SUPPL-23 | Labeling |
Label is not available on this site. |
||
| 12/01/1998 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/11/1996 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
| 12/23/1994 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/11/1994 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/21/1993 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
| 04/03/1992 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/03/1992 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/06/1991 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 04/23/1991 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/25/1989 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 01/25/1989 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 01/11/1989 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/21/1988 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/31/1987 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/21/1988 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/21/1988 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/21/1988 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |