Drugs@FDA: FDA-Approved Drugs
Company: ANI PHARMS INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 50MG | 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 |
|---|---|---|---|---|---|---|---|
| 11/19/1976 | 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 |
|---|---|---|---|---|---|
| 04/25/2016 | SUPPL-309 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/17/2014 | SUPPL-308 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/18/1997 | SUPPL-307 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/11/1995 | SUPPL-306 | Labeling |
Label is not available on this site. |
||
| 02/15/1995 | SUPPL-305 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/16/1995 | SUPPL-304 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/30/1994 | SUPPL-303 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/06/1994 | SUPPL-302 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/17/1994 | SUPPL-301 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/23/1994 | SUPPL-300 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/18/1993 | SUPPL-299 | Labeling |
Label is not available on this site. |
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| 06/12/1992 | SUPPL-298 | Labeling |
Label is not available on this site. |
||
| 12/31/1991 | SUPPL-295 | Labeling |
Label is not available on this site. |
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| 06/10/1992 | SUPPL-294 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/05/1989 | SUPPL-293 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/05/1989 | SUPPL-292 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/31/1988 | SUPPL-290 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/30/1987 | SUPPL-288 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/04/1987 | SUPPL-287 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/30/1987 | SUPPL-285 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/28/1986 | SUPPL-284 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/28/1986 | SUPPL-283 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/12/1986 | SUPPL-282 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/12/1986 | SUPPL-281 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/30/1987 | SUPPL-280 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/06/1985 | SUPPL-279 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/11/1985 | SUPPL-278 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/21/1984 | SUPPL-276 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/06/1985 | SUPPL-275 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/27/1984 | SUPPL-274 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/15/1984 | SUPPL-273 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/16/1983 | SUPPL-271 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/28/1983 | SUPPL-270 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/12/1983 | SUPPL-263 | Manufacturing (CMC) |
Label is not available on this site. |