Drugs@FDA: FDA-Approved Drugs
Company: FOSUN PHARMA
| 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 |
|---|---|---|---|---|---|---|---|
| 11/27/1987 | 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 |
|---|---|---|---|---|---|
| 02/23/2017 | SUPPL-25 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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| 04/25/2016 | SUPPL-24 | Labeling-Package Insert |
Label is not available on this site. |
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| 01/17/2015 | SUPPL-23 | Labeling-Package Insert |
Label is not available on this site. |
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| 07/18/2014 | SUPPL-22 | Labeling-Package Insert |
Label is not available on this site. |
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| 12/06/2012 | SUPPL-21 | Labeling-Package Insert |
Label is not available on this site. |
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| 12/16/2002 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 08/08/2001 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 04/02/2001 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 04/03/2000 | SUPPL-13 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
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| 10/07/1999 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/05/1999 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/13/1999 | SUPPL-10 | Labeling |
Label is not available on this site. |
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| 04/13/1999 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/28/1997 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/05/1996 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/26/1996 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/10/1995 | SUPPL-5 | Labeling |
Label is not available on this site. |
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| 01/24/1994 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/29/1993 | SUPPL-3 | Labeling |
Label is not available on this site. |
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| 09/09/1988 | SUPPL-2 | Labeling |
Label is not available on this site. |