Amitriptyline Hydrochloride

ANDA 86157, held by Mylan. Amitriptyline Hydrochloride.

As of Nov 15, 2026, ANDA 86157 (Amitriptyline Hydrochloride), held by Mylan, was first approved by FDA on Apr 26, 1978, with 23 approved supplements and 0 published complete response letters.

First approved: Apr 26, 1978
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
Apr 26, 1978	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Amitriptyline Hydrochloride10MG · tablet; oral	Amitriptyline Hydrochloride	Rx

All 24 submissions, including labeling and manufacturing supplements


May 7, 2002	Supplement 47Labeling	Approved	None posted
Jan 29, 2001	Supplement 46Labeling	Approved	None posted
Mar 12, 1999	Supplement 45Manufacturing	Approved	None posted
Mar 12, 1999	Supplement 44Manufacturing	Approved	None posted
Feb 25, 1998	Supplement 43Manufacturing	Approved	None posted
Feb 5, 1998	Supplement 42Manufacturing	Approved	None posted
Jun 1, 1995	Supplement 41Labeling	Approved	None posted
Jun 1, 1995	Supplement 39Manufacturing	Approved	None posted
Jun 1, 1995	Supplement 38Manufacturing	Approved	None posted
Jun 1, 1995	Supplement 37Manufacturing	Approved	None posted
Apr 24, 1995	Supplement 40Labeling	Approved	None posted
Nov 24, 1993	Supplement 36Manufacturing	Approved	None posted
Jul 2, 1993	Supplement 35Labeling	Approved	None posted
Nov 14, 1991	Supplement 33Labeling	Approved	None posted
Dec 28, 1990	Supplement 49Labeling	Approved	None posted
Dec 28, 1990	Supplement 32Labeling	Approved	None posted
Jul 11, 1989	Supplement 31Manufacturing	Approved	None posted
Feb 18, 1988	Supplement 26Manufacturing	Approved	None posted
Jun 15, 1984	Supplement 20Manufacturing	Approved	None posted
May 24, 1984	Supplement 21Manufacturing	Approved	None posted
Jun 21, 1983	Supplement 19Manufacturing	Approved	None posted
Jan 24, 1983	Supplement 18Manufacturing	Approved	None posted
Jan 24, 1983	Supplement 17Manufacturing	Approved	None posted
Apr 26, 1978	Original application	Approved	None posted

Identifiers

Application: ANDA 86157
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