Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 070297
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-Medication Guide, Labeling-Package Insert

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.

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.

09/19/1995 SUPPL-24 Labeling

Label is not available on this site.

12/23/1994 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

10/11/1994 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

10/19/1993 SUPPL-21 Labeling

Label is not available on this site.

04/03/1992 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

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.

11/28/1989 SUPPL-11 Labeling

Label is not available on this site.

01/22/1991 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

01/22/1991 SUPPL-8 Labeling

Label is not available on this site.

01/06/1989 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

01/06/1989 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

01/06/1989 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

01/06/1989 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

01/26/1988 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

03/31/1987 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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