U.S. flag An official website of the United States government
  1. Home
  2. Drug Databases
  3. Drugs@FDA

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 071063
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.

04/25/2016 SUPPL-24 Labeling-Package Insert

Label is not available on this site.

01/17/2015 SUPPL-23 Labeling-Package Insert

Label is not available on this site.

07/18/2014 SUPPL-22 Labeling-Package Insert

Label is not available on this site.

12/06/2012 SUPPL-21 Labeling-Package Insert

Label is not available on this site.

12/16/2002 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

08/08/2001 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

04/02/2001 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

04/03/2000 SUPPL-13 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

10/07/1999 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

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.

04/13/1999 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

10/28/1997 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

12/05/1996 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

04/26/1996 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

04/10/1995 SUPPL-5 Labeling

Label is not available on this site.

01/24/1994 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

06/29/1993 SUPPL-3 Labeling

Label is not available on this site.

09/09/1988 SUPPL-2 Labeling

Label is not available on this site.

Back to Top