Drugs@FDA: FDA-Approved Drugs
Company: ANI PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PERPHENAZINE | PERPHENAZINE | 16MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | No | No |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 |
|---|---|---|---|---|---|---|---|
| 09/10/1987 | 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 |
|---|---|---|---|---|---|
| 07/29/2002 | SUPPL-27 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 03/12/2002 | SUPPL-26 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 09/20/2002 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
| 09/20/2002 | SUPPL-19 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
||
| 03/28/2000 | SUPPL-18 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 01/28/2000 | SUPPL-17 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 11/23/1999 | SUPPL-16 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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| 08/20/1999 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/09/1998 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/30/1997 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/28/1995 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/19/1993 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/07/1994 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/28/1995 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/26/1993 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/08/1992 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/04/1990 | SUPPL-6 | Labeling |
Label is not available on this site. |
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| 02/23/1991 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/20/1987 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/20/1987 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/28/1987 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |