Perphenazine And Amitriptyline Hydrochloride

ANDA 71079, held by Sun Pharm Industries. Amitriptyline Hydrochloride; Perphenazine.

As of Nov 15, 2026, ANDA 71079 (Perphenazine And Amitriptyline Hydrochloride), held by Sun Pharm Industries, was first approved by FDA on Nov 12, 1986, with 22 approved supplements and 0 published complete response letters.

First approved: Nov 12, 1986
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 12, 1986	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 23 submissions, including labeling and manufacturing supplements


Jun 24, 2025	Supplement 31Labeling · Standard review	Approved	None posted
Jan 22, 2025	Supplement 30Labeling · Standard review	Approved	None posted
Feb 23, 2017	Supplement 29Labeling · Standard review	Approved	None posted
Apr 25, 2016	Supplement 28Labeling · Standard review	Approved	None posted
Jul 17, 2014	Supplement 27Labeling · Standard review	Approved	None posted
Sep 30, 2010	Supplement 26Labeling	Approved	None posted
Dec 1, 1998	Supplement 25Manufacturing	Approved	None posted
Sep 19, 1995	Supplement 24Labeling	Approved	None posted
Dec 23, 1994	Supplement 23Manufacturing	Approved	None posted
Oct 11, 1994	Supplement 22Manufacturing	Approved	None posted
Oct 19, 1993	Supplement 21Labeling	Approved	None posted
Apr 3, 1992	Supplement 20Manufacturing	Approved	None posted
Apr 3, 1992	Supplement 18Manufacturing	Approved	None posted
Jan 22, 1991	Supplement 10Manufacturing	Approved	None posted
Jan 22, 1991	Supplement 9Labeling	Approved	None posted
May 3, 1990	Supplement 14Bioequivalence	Approved	None posted
Nov 28, 1989	Supplement 12Labeling	Approved	None posted
Jan 6, 1989	Supplement 8Manufacturing	Approved	None posted
Jan 6, 1989	Supplement 7Manufacturing	Approved	None posted
Jan 6, 1989	Supplement 6Manufacturing	Approved	None posted
Jan 6, 1989	Supplement 5Manufacturing	Approved	None posted
Jan 26, 1988	Supplement 3Manufacturing	Approved	None posted
Nov 12, 1986	Original application	Approved	None posted

Identifiers

Application: ANDA 71079
Drugs@FDA: Overview at FDA
Company: Sun Pharmaceutical Industries

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