Perphenazine And Amitriptyline Hydrochloride

ANDA 71063, held by Fosun Pharma. Amitriptyline Hydrochloride; Perphenazine.

As of Nov 15, 2026, ANDA 71063 (Perphenazine And Amitriptyline Hydrochloride), held by Fosun Pharma, was first approved by FDA on Nov 27, 1987, with 22 approved supplements and 0 published complete response letters.

First approved: Nov 27, 1987
Supplements approved: 22
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 23 submissions below

Date	Submission	Status	Documents
Nov 27, 1987	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Perphenazine And Amitriptyline Hydrochloride25MG;2MG · tablet;oral	Amitriptyline Hydrochloride; Perphenazine	Discontinued

All 23 submissions, including labeling and manufacturing supplements


Jun 24, 2025	Supplement 27Labeling · Standard review	Approved	None posted
Jan 22, 2025	Supplement 26Labeling · Standard review	Approved	None posted
Feb 23, 2017	Supplement 25Labeling · Standard review	Approved	None posted
Apr 25, 2016	Supplement 24Labeling · Standard review	Approved	None posted
Jan 17, 2015	Supplement 23Labeling · Standard review	Approved	None posted
Jul 18, 2014	Supplement 22Labeling · Standard review	Approved	None posted
Dec 6, 2012	Supplement 21Labeling	Approved	None posted
Dec 16, 2002	Supplement 16Manufacturing	Approved	None posted
Aug 8, 2001	Supplement 15Manufacturing	Approved	None posted
Apr 2, 2001	Supplement 14Manufacturing	Approved	None posted
Apr 3, 2000	Supplement 13Manufacturing	Approved	None posted
Oct 7, 1999	Supplement 12Manufacturing	Approved	None posted
May 5, 1999	Supplement 11Manufacturing	Approved	None posted
Apr 13, 1999	Supplement 10Labeling	Approved	None posted
Apr 13, 1999	Supplement 9Manufacturing	Approved	None posted
Oct 28, 1997	Supplement 8Manufacturing	Approved	None posted
Dec 5, 1996	Supplement 7Manufacturing	Approved	None posted
Apr 26, 1996	Supplement 6Manufacturing	Approved	None posted
Apr 10, 1995	Supplement 5Labeling	Approved	None posted
Jan 24, 1994	Supplement 4Manufacturing	Approved	None posted
Jun 29, 1993	Supplement 3Labeling	Approved	None posted
Sep 9, 1988	Supplement 2Labeling	Approved	None posted
Nov 27, 1987	Original application	Approved	None posted

Identifiers

Application: ANDA 71063
Drugs@FDA: Overview at FDA
Company: Fosun Pharma

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters