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 | 50MG;4MG | 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 |
---|---|---|---|---|---|---|---|
12/21/1987 | 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-19 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
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04/25/2016 | SUPPL-18 | Labeling-Package Insert |
Label is not available on this site. |
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01/17/2015 | SUPPL-17 | Labeling-Package Insert |
Label is not available on this site. |
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07/18/2014 | SUPPL-16 | Labeling-Package Insert |
Label is not available on this site. |
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12/06/2012 | SUPPL-15 | Labeling-Package Insert |
Label is not available on this site. |
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04/26/2001 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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10/07/1999 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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05/05/1999 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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10/28/1997 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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11/20/1995 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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04/26/1996 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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04/10/1995 | SUPPL-3 | Labeling |
Label is not available on this site. |
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06/29/1993 | SUPPL-2 | Labeling |
Label is not available on this site. |
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09/09/1988 | SUPPL-1 | Labeling |
Label is not available on this site. |