Amitriptyline Hydrochloride

ANDA 85745, held by Mutual Pharm. Amitriptyline Hydrochloride.

As of Nov 15, 2026, ANDA 85745 (Amitriptyline Hydrochloride), held by Mutual Pharm, was first approved by FDA on Jul 11, 1977, with 23 approved supplements and 0 published complete response letters.

First approved: Jul 11, 1977
Supplements approved: 23
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 24 submissions below

Date	Submission	Status	Documents
Jul 11, 1977	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Amitriptyline Hydrochloride50MG · tablet;oral	Amitriptyline Hydrochloride	Discontinued

All 24 submissions, including labeling and manufacturing supplements


Dec 1, 1998	Supplement 88Manufacturing	Approved	None posted
Oct 16, 1995	Supplement 87Labeling	Approved	None posted
Dec 23, 1994	Supplement 86Manufacturing	Approved	None posted
Oct 11, 1994	Supplement 85Manufacturing	Approved	None posted
Sep 3, 1993	Supplement 84Labeling	Approved	None posted
Apr 3, 1992	Supplement 83Manufacturing	Approved	None posted
Apr 3, 1992	Supplement 81Manufacturing	Approved	None posted
Jan 31, 1992	Supplement 80Labeling	Approved	None posted
Dec 30, 1991	Supplement 79Labeling	Approved	None posted
Feb 28, 1990	Supplement 78Manufacturing	Approved	None posted
Feb 28, 1990	Supplement 77Manufacturing	Approved	None posted
Feb 28, 1990	Supplement 76Labeling	Approved	None posted
Feb 28, 1990	Supplement 75Manufacturing	Approved	None posted
Sep 29, 1987	Supplement 73Manufacturing	Approved	None posted
Sep 29, 1987	Supplement 72Manufacturing	Approved	None posted
Sep 29, 1987	Supplement 71Manufacturing	Approved	None posted
Mar 20, 1987	Supplement 70Manufacturing	Approved	None posted
Aug 12, 1985	Supplement 66Manufacturing	Approved	None posted
Aug 12, 1985	Supplement 65Manufacturing	Approved	None posted
Aug 12, 1985	Supplement 64Manufacturing	Approved	None posted
Aug 12, 1985	Supplement 63Manufacturing	Approved	None posted
May 11, 1982	Supplement 47Manufacturing	Approved	None posted
May 11, 1982	Supplement 46Manufacturing	Approved	None posted
Jul 11, 1977	Original application	Approved	None posted

Identifiers

Application: ANDA 85745
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