Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 070870
Company: ANI PHARMS
Company: ANI PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ACETOHEXAMIDE | ACETOHEXAMIDE | 500MG | TABLET;ORAL | Discontinued | None | No | No |
| ACETOHEXAMIDE | ACETOHEXAMIDE | 250MG | 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 |
|---|---|---|---|---|---|---|---|
| 02/09/1987 | 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 |
|---|---|---|---|---|---|
| 06/13/2002 | SUPPL-21 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/26/2001 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
| 12/21/1999 | SUPPL-19 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 05/21/1999 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/20/1999 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/01/1998 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/03/1995 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/23/1994 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/29/1994 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/11/1994 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/03/1992 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/03/1992 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/28/1991 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 09/11/1991 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 12/13/1990 | SUPPL-6 | Bioequivalence |
Label is not available on this site. |
||
| 08/02/1991 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/02/1991 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/31/1987 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |