Perphenazine And Amitriptyline Hydrochloride

ANDA 71064, held by Fosun Pharma. Amitriptyline Hydrochloride; Perphenazine.

As of Nov 15, 2026, ANDA 71064 (Perphenazine And Amitriptyline Hydrochloride), held by Fosun Pharma, was first approved by FDA on Nov 27, 1987, with 17 approved supplements and 0 published complete response letters.

First approved: Nov 27, 1987
Supplements approved: 17
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 18 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;4MG · tablet;oral	Amitriptyline Hydrochloride; Perphenazine	Discontinued

All 18 submissions, including labeling and manufacturing supplements


Jun 24, 2025	Supplement 22Labeling · Standard review	Approved	None posted
Jan 22, 2025	Supplement 21Labeling · Standard review	Approved	None posted
Feb 23, 2017	Supplement 20Labeling · Standard review	Approved	None posted
Apr 25, 2016	Supplement 19Labeling · Standard review	Approved	None posted
Jan 17, 2015	Supplement 18Labeling · Standard review	Approved	None posted
Jul 18, 2014	Supplement 17Labeling · Standard review	Approved	None posted
Dec 6, 2012	Supplement 16Labeling	Approved	None posted
Aug 8, 2001	Supplement 11Manufacturing	Approved	None posted
Apr 2, 2001	Supplement 10Manufacturing	Approved	None posted
May 5, 1999	Supplement 9Manufacturing	Approved	None posted
Oct 28, 1997	Supplement 8Manufacturing	Approved	None posted
May 14, 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 71064
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