Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 087093
Company: ANI PHARMS
Company: ANI PHARMS
| 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 |
|---|---|---|---|---|---|---|---|
| 03/25/1980 | 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 |
|---|---|---|---|---|---|
| 01/28/2000 | SUPPL-40 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 11/23/1999 | SUPPL-39 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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| 08/20/1999 | SUPPL-38 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/09/1998 | SUPPL-37 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/26/1998 | SUPPL-36 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/26/1998 | SUPPL-35 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/30/1997 | SUPPL-34 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/26/1993 | SUPPL-33 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/05/1992 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/28/1991 | SUPPL-31 | Labeling |
Label is not available on this site. |
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| 11/03/1987 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/03/1987 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/03/1987 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/07/1987 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/07/1987 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/07/1987 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/07/1987 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/21/1982 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |