Amitriptyline Hydrochloride

ANDA 86010, held by Mylan. Amitriptyline Hydrochloride.

As of Nov 15, 2026, ANDA 86010 (Amitriptyline Hydrochloride), held by Mylan, was first approved by FDA on Apr 10, 1978, with 24 approved supplements and 0 published complete response letters.

First approved: Apr 10, 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 10, 1978	Original application	Approved	None posted

Products

1 strengths and forms

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

All 25 submissions, including labeling and manufacturing supplements


May 7, 2002	Supplement 53Labeling	Approved	None posted
Jan 29, 2001	Supplement 52Labeling	Approved	None posted
Mar 12, 1999	Supplement 51Manufacturing	Approved	None posted
Mar 12, 1999	Supplement 50Manufacturing	Approved	None posted
Feb 25, 1998	Supplement 49Manufacturing	Approved	None posted
Feb 5, 1998	Supplement 48Manufacturing	Approved	None posted
Jun 1, 1995	Supplement 47Labeling	Approved	None posted
Jun 1, 1995	Supplement 45Manufacturing	Approved	None posted
Jun 1, 1995	Supplement 44Manufacturing	Approved	None posted
Jun 1, 1995	Supplement 43Manufacturing	Approved	None posted
Apr 24, 1995	Supplement 46Labeling	Approved	None posted
Nov 24, 1993	Supplement 42Manufacturing	Approved	None posted
Jul 2, 1993	Supplement 55Labeling	Approved	None posted
Nov 14, 1991	Supplement 41Labeling	Approved	None posted
Aug 17, 1989	Supplement 40Bioequivalence	Approved	None posted
Aug 17, 1989	Supplement 39Bioequivalence	Approved	None posted
Jul 11, 1989	Supplement 38Manufacturing	Approved	None posted
Jul 11, 1989	Supplement 37Manufacturing	Approved	None posted
Feb 18, 1988	Supplement 33Manufacturing	Approved	None posted
Jul 2, 1986	Supplement 32Manufacturing	Approved	None posted
Nov 23, 1984	Supplement 30Manufacturing	Approved	None posted
Jun 15, 1984	Supplement 28Manufacturing	Approved	None posted
Jan 21, 1983	Supplement 27Manufacturing	Approved	None posted
Jan 21, 1983	Supplement 26Manufacturing	Approved	None posted
Apr 10, 1978	Original application	Approved	None posted

Identifiers

Application: ANDA 86010
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