Amitriptyline Hydrochloride

ANDA 86153, held by Mylan. Amitriptyline Hydrochloride.

As of Nov 15, 2026, ANDA 86153 (Amitriptyline Hydrochloride), held by Mylan, was first approved by FDA on Apr 26, 1978, with 20 approved supplements and 0 published complete response letters.

First approved: Apr 26, 1978
Supplements approved: 20
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 21 submissions below

Date	Submission	Status	Documents
Apr 26, 1978	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Amitriptyline Hydrochloride150MG · tablet; oral	Amitriptyline Hydrochloride	Rx

All 21 submissions, including labeling and manufacturing supplements


May 7, 2002	Supplement 39Labeling	Approved	None posted
Jan 29, 2001	Supplement 38Labeling	Approved	None posted
Mar 12, 1999	Supplement 37Manufacturing	Approved	None posted
Mar 12, 1999	Supplement 36Manufacturing	Approved	None posted
Feb 25, 1998	Supplement 35Manufacturing	Approved	None posted
Feb 5, 1998	Supplement 34Manufacturing	Approved	None posted
Jun 1, 1995	Supplement 33Labeling	Approved	None posted
Jun 1, 1995	Supplement 31Manufacturing	Approved	None posted
Jun 1, 1995	Supplement 30Manufacturing	Approved	None posted
Jun 1, 1995	Supplement 29Manufacturing	Approved	None posted
Apr 24, 1995	Supplement 32Labeling	Approved	None posted
Nov 24, 1993	Supplement 28Manufacturing	Approved	None posted
Jul 2, 1993	Supplement 27Labeling	Approved	None posted
Nov 14, 1991	Supplement 25Labeling	Approved	None posted
Jan 31, 1990	Supplement 24Manufacturing	Approved	None posted
Feb 18, 1988	Supplement 20Manufacturing	Approved	None posted
Jul 2, 1986	Supplement 19Manufacturing	Approved	None posted
Jun 15, 1984	Supplement 15Manufacturing	Approved	None posted
Jan 19, 1983	Supplement 14Manufacturing	Approved	None posted
Jan 19, 1983	Supplement 13Manufacturing	Approved	None posted
Apr 26, 1978	Original application	Approved	None posted

Identifiers

Application: ANDA 86153
Drugs@FDA: Overview at FDA
Company: Mylan

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