Amitriptyline Hydrochloride

ANDA 85627, held by Mutual Pharm. Amitriptyline Hydrochloride.

As of Nov 15, 2026, ANDA 85627 (Amitriptyline Hydrochloride), held by Mutual Pharm, was first approved by FDA on May 10, 1977, with 23 approved supplements and 0 published complete response letters.

First approved: May 10, 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
May 10, 1977	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Amitriptyline Hydrochloride25MG · tablet;oral	Amitriptyline Hydrochloride	Discontinued

All 24 submissions, including labeling and manufacturing supplements


Dec 1, 1998	Supplement 95Manufacturing	Approved	None posted
Oct 16, 1995	Supplement 94Labeling	Approved	None posted
Dec 23, 1994	Supplement 93Manufacturing	Approved	None posted
Oct 11, 1994	Supplement 92Manufacturing	Approved	None posted
Sep 3, 1993	Supplement 91Labeling	Approved	None posted
Apr 3, 1992	Supplement 90Manufacturing	Approved	None posted
Apr 3, 1992	Supplement 88Manufacturing	Approved	None posted
Jan 31, 1992	Supplement 87Labeling	Approved	None posted
Dec 30, 1991	Supplement 86Labeling	Approved	None posted
Feb 28, 1990	Supplement 85Labeling	Approved	None posted
Feb 28, 1990	Supplement 84Manufacturing	Approved	None posted
Feb 28, 1990	Supplement 83Manufacturing	Approved	None posted
Feb 12, 1988	Supplement 82Manufacturing	Approved	None posted
Sep 29, 1987	Supplement 80Manufacturing	Approved	None posted
Sep 29, 1987	Supplement 79Manufacturing	Approved	None posted
Sep 29, 1987	Supplement 78Manufacturing	Approved	None posted
Mar 31, 1987	Supplement 74Manufacturing	Approved	None posted
Jul 11, 1986	Supplement 71Manufacturing	Approved	None posted
Mar 14, 1986	Supplement 73Manufacturing	Approved	None posted
Aug 12, 1985	Supplement 69Manufacturing	Approved	None posted
Aug 12, 1985	Supplement 68Manufacturing	Approved	None posted
Aug 12, 1985	Supplement 67Manufacturing	Approved	None posted
Aug 12, 1985	Supplement 66Manufacturing	Approved	None posted
May 10, 1977	Original application	Approved	None posted

Identifiers

Application: ANDA 85627
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