Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 086109
Company: WATSON LABS
Company: WATSON LABS
| 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 |
|---|---|---|---|---|---|---|---|
| 01/30/1979 | 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 |
|---|---|---|---|---|---|
| 07/17/1998 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/23/1997 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/17/1994 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/12/1995 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/18/1991 | SUPPL-26 | Labeling |
Label is not available on this site. |
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| 03/08/1988 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/17/1987 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/17/1987 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/15/1986 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/02/1984 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/27/1983 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/27/1983 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |