Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 073009
Company: HERITAGE PHARMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE 10MG;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
10/17/1991 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-27 Labeling-Package Insert

Label is not available on this site.

04/25/2016 SUPPL-26 Labeling-Package Insert

Label is not available on this site.

01/16/2015 SUPPL-25 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

07/17/2014 SUPPL-24 Labeling-Package Insert

Label is not available on this site.

11/03/2015 SUPPL-23 Labeling-Package Insert

Label is not available on this site.

04/25/2001 SUPPL-22 Labeling

Label is not available on this site.

02/28/2001 SUPPL-21 Labeling

Label is not available on this site.

04/12/2001 SUPPL-20 Manufacturing (CMC)-Facility

Label is not available on this site.

03/21/2000 SUPPL-18 Manufacturing (CMC)-Facility

Label is not available on this site.

05/07/1999 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

06/16/1998 SUPPL-16 Labeling

Label is not available on this site.

06/16/1998 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

06/16/1998 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

07/08/1997 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

12/31/1996 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

12/31/1996 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

04/29/1996 SUPPL-7 Labeling

Label is not available on this site.

03/26/1997 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

03/26/1997 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

03/26/1997 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

03/26/1997 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

08/29/1995 SUPPL-2 Labeling

Label is not available on this site.

08/31/1993 SUPPL-1 Labeling

Label is not available on this site.

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