Amitriptyline Hydrochloride

ANDA 89400, held by Mutual Pharm. Amitriptyline Hydrochloride.

As of Nov 15, 2026, ANDA 89400 (Amitriptyline Hydrochloride), held by Mutual Pharm, was first approved by FDA on Jul 14, 1987, with 19 approved supplements and 0 published complete response letters.

First approved: Jul 14, 1987
Supplements approved: 19
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 20 submissions below

Date	Submission	Status	Documents
Jul 14, 1987	Original application	Approved	None posted

Products

1 strengths and forms

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

All 20 submissions, including labeling and manufacturing supplements


Nov 21, 2007	Supplement 32Labeling	Approved	None posted
Jul 16, 2007	Supplement 30Labeling	Approved	None posted
Jun 29, 2007	Supplement 31Labeling	Approved	None posted
Aug 26, 2005	Supplement 24Labeling	Approved	None posted
May 5, 2005	Supplement 23Labeling	Approved	None posted
Sep 30, 2002	Supplement 15Manufacturing	Approved	None posted
Aug 22, 2001	Supplement 13Labeling	Approved	None posted
Jul 5, 2001	Supplement 12Manufacturing	Approved	None posted
Mar 22, 2001	Supplement 11Manufacturing	Approved	None posted
May 16, 2000	Supplement 10Manufacturing	Approved	None posted
May 16, 2000	Supplement 9Manufacturing	Approved	None posted
Dec 5, 1997	Supplement 8Manufacturing	Approved	None posted
Feb 24, 1997	Supplement 7Manufacturing	Approved	None posted
Aug 22, 1995	Supplement 6Labeling	Approved	None posted
Jun 22, 1995	Supplement 5Manufacturing	Approved	None posted
Jan 12, 1994	Supplement 4Manufacturing	Approved	None posted
Aug 16, 1993	Supplement 3Labeling	Approved	None posted
May 15, 1992	Supplement 2Labeling	Approved	None posted
Feb 27, 1992	Supplement 1Manufacturing	Approved	None posted
Jul 14, 1987	Original application	Approved	None posted

Identifiers

Application: ANDA 89400
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