Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 086445
Company: MYLAN PHARMS INC
Company: MYLAN PHARMS INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TOLBUTAMIDE | TOLBUTAMIDE | 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 |
|---|---|---|---|---|---|---|---|
| 04/10/1979 | 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 |
|---|---|---|---|---|---|
| 11/12/2009 | SUPPL-63 | Labeling |
Label is not available on this site. |
||
| 09/27/2001 | SUPPL-59 | Labeling |
Label is not available on this site. |
||
| 02/05/1998 | SUPPL-58 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/25/1998 | SUPPL-57 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/03/1993 | SUPPL-56 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/23/1991 | SUPPL-54 | Labeling |
Label is not available on this site. |
||
| 01/31/1990 | SUPPL-53 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/08/1989 | SUPPL-52 | Labeling |
Label is not available on this site. |
||
| 08/28/1987 | SUPPL-51 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/18/1984 | SUPPL-45 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/18/1982 | SUPPL-43 | Manufacturing (CMC) |
Label is not available on this site. |