Amitriptyline Hydrochloride

ANDA 86158, held by Mylan. Amitriptyline Hydrochloride.

As of Nov 15, 2026, ANDA 86158 (Amitriptyline Hydrochloride), held by Mylan, was first approved by FDA on Apr 26, 1978, with 24 approved supplements and 0 published complete response letters.

First approved: Apr 26, 1978
Supplements approved: 24
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 25 submissions below

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

Products

1 strengths and forms

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

All 25 submissions, including labeling and manufacturing supplements


May 7, 2002	Supplement 44Labeling	Approved	None posted
Jan 29, 2001	Supplement 43Labeling	Approved	None posted
Mar 12, 1999	Supplement 42Manufacturing	Approved	None posted
Mar 12, 1999	Supplement 41Manufacturing	Approved	None posted
Feb 25, 1998	Supplement 40Manufacturing	Approved	None posted
Feb 5, 1998	Supplement 39Manufacturing	Approved	None posted
Jun 1, 1995	Supplement 38Labeling	Approved	None posted
Jun 1, 1995	Supplement 36Manufacturing	Approved	None posted
Jun 1, 1995	Supplement 35Manufacturing	Approved	None posted
Jun 1, 1995	Supplement 34Manufacturing	Approved	None posted
Apr 24, 1995	Supplement 37Labeling	Approved	None posted
Nov 24, 1993	Supplement 33Manufacturing	Approved	None posted
Jul 2, 1993	Supplement 32Labeling	Approved	None posted
Nov 14, 1991	Supplement 30Labeling	Approved	None posted
Aug 17, 1989	Supplement 28Bioequivalence	Approved	None posted
Jul 24, 1989	Supplement 29Bioequivalence	Approved	None posted
Jul 11, 1989	Supplement 27Manufacturing	Approved	None posted
Jul 11, 1989	Supplement 26Manufacturing	Approved	None posted
Feb 18, 1988	Supplement 22Manufacturing	Approved	None posted
Jul 2, 1986	Supplement 21Manufacturing	Approved	None posted
Nov 26, 1984	Supplement 18Manufacturing	Approved	None posted
Jun 15, 1984	Supplement 17Manufacturing	Approved	None posted
Jan 19, 1983	Supplement 16Manufacturing	Approved	None posted
Jan 19, 1983	Supplement 15Manufacturing	Approved	None posted
Apr 26, 1978	Original application	Approved	None posted

Identifiers

Application: ANDA 86158
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