Amitriptyline Hydrochloride

ANDA 85742, held by Mutual Pharm. Amitriptyline Hydrochloride.

As of Nov 15, 2026, ANDA 85742 (Amitriptyline Hydrochloride), held by Mutual Pharm, was first approved by FDA on Jul 13, 1977, with 21 approved supplements and 0 published complete response letters.

First approved: Jul 13, 1977
Supplements approved: 21
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 22 submissions below

Date	Submission	Status	Documents
Jul 13, 1977	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Amitriptyline Hydrochloride100MG · tablet;oral	Amitriptyline Hydrochloride	Discontinued

All 22 submissions, including labeling and manufacturing supplements


Dec 1, 1998	Supplement 65Manufacturing	Approved	None posted
Oct 16, 1995	Supplement 64Labeling	Approved	None posted
Dec 23, 1994	Supplement 63Manufacturing	Approved	None posted
Oct 11, 1994	Supplement 62Manufacturing	Approved	None posted
Sep 3, 1993	Supplement 61Labeling	Approved	None posted
Apr 3, 1992	Supplement 60Manufacturing	Approved	None posted
Apr 3, 1992	Supplement 58Manufacturing	Approved	None posted
Jan 31, 1992	Supplement 57Labeling	Approved	None posted
Dec 30, 1991	Supplement 56Labeling	Approved	None posted
Feb 28, 1990	Supplement 55Labeling	Approved	None posted
Feb 28, 1990	Supplement 54Manufacturing	Approved	None posted
Apr 7, 1989	Supplement 34Manufacturing	Approved	None posted
Sep 29, 1987	Supplement 52Manufacturing	Approved	None posted
Sep 29, 1987	Supplement 51Manufacturing	Approved	None posted
Sep 29, 1987	Supplement 50Manufacturing	Approved	None posted
Mar 20, 1987	Supplement 49Manufacturing	Approved	None posted
Feb 3, 1986	Supplement 47Manufacturing	Approved	None posted
Nov 18, 1985	Supplement 46Manufacturing	Approved	None posted
Nov 18, 1985	Supplement 45Manufacturing	Approved	None posted
May 11, 1982	Supplement 31Manufacturing	Approved	None posted
May 11, 1982	Supplement 30Manufacturing	Approved	None posted
Jul 13, 1977	Original application	Approved	None posted

Identifiers

Application: ANDA 85742
Drugs@FDA: Overview at FDA
Company: Mutual Pharmaceutical Company

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