Drugs@FDA: FDA-Approved Drugs
Company: SUN PHARM INDUSTRIES
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE | 25MG;2MG | 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 |
|---|---|---|---|---|---|---|---|
| 11/12/1986 | 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 |
|---|---|---|---|---|---|
| 02/23/2017 | SUPPL-29 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 04/25/2016 | SUPPL-28 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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| 07/17/2014 | SUPPL-27 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/30/2010 | SUPPL-26 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/01/1998 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/19/1995 | SUPPL-24 | Labeling |
Label is not available on this site. |
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| 12/23/1994 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/11/1994 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/19/1993 | SUPPL-21 | Labeling |
Label is not available on this site. |
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| 04/03/1992 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/03/1992 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/03/1990 | SUPPL-14 | Bioequivalence |
Label is not available on this site. |
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| 11/28/1989 | SUPPL-11 | Labeling |
Label is not available on this site. |
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| 01/22/1991 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/22/1991 | SUPPL-8 | Labeling |
Label is not available on this site. |
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| 01/06/1989 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/06/1989 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/06/1989 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/06/1989 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/26/1988 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/31/1987 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |