Amitriptyline Hydrochloride

Relieves symptoms of depression. ANDA 86009, held by Aurobindo Pharma USA. Amitriptyline Hydrochloride.

As of Nov 15, 2026, ANDA 86009 (Amitriptyline Hydrochloride), held by Aurobindo Pharma USA, was first approved by FDA on Apr 10, 1978, with 32 approved supplements and 0 published complete response letters.

First approved: Apr 10, 1978
Supplements approved: 32
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE: For the relief of symptoms of depression. Endogenous depression is more likely to be alleviated than are other depressive states.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 33 submissions below

Date	Submission	Status	Documents
Apr 10, 1978	Original application	Approved	None posted

Products

6 strengths and forms


Amitriptyline Hydrochloride50MG · tablet;oral	Amitriptyline Hydrochloride	Rx
Amitriptyline Hydrochloride10MG · tablet;oral	Amitriptyline Hydrochloride	Rx
Amitriptyline Hydrochloride25MG · tablet;oral	Amitriptyline Hydrochloride	Rx
Amitriptyline Hydrochloride75MG · tablet;oral	Amitriptyline Hydrochloride	Rx
Amitriptyline Hydrochloride100MG · tablet;oral	Amitriptyline Hydrochloride	Rx
Amitriptyline Hydrochloride150MG · tablet;oral	Amitriptyline Hydrochloride	Rx

All 33 submissions, including labeling and manufacturing supplements


Jun 24, 2025	Supplement 71Labeling · Standard review	Approved	None posted
Apr 25, 2016	Supplement 67Labeling · Standard review	Approved	None posted
Jul 17, 2014	Supplement 66Labeling · Standard review	Approved	None posted
Apr 14, 2008	Supplement 59Labeling	Approved	None posted
Nov 21, 2007	Supplement 61Labeling	Approved	None posted
Jul 11, 2007	Supplement 58Labeling	Approved	None posted
Jul 8, 2005	Supplement 51Labeling	Approved	None posted
May 7, 2002	Supplement 49Labeling	Approved	None posted
Jan 29, 2001	Supplement 48Labeling	Approved	None posted
Mar 12, 1999	Supplement 47Manufacturing	Approved	None posted
Mar 12, 1999	Supplement 46Manufacturing	Approved	None posted
Feb 25, 1998	Supplement 45Manufacturing	Approved	None posted
Feb 5, 1998	Supplement 44Manufacturing	Approved	None posted
Jun 1, 1995	Supplement 43Labeling	Approved	None posted
Jun 1, 1995	Supplement 41Manufacturing	Approved	None posted
Jun 1, 1995	Supplement 40Manufacturing	Approved	None posted
Jun 1, 1995	Supplement 39Manufacturing	Approved	None posted
Apr 24, 1995	Supplement 42Labeling	Approved	None posted
Nov 24, 1993	Supplement 38Manufacturing	Approved	None posted
Jul 2, 1993	Supplement 37Labeling	Approved	None posted
Nov 14, 1991	Supplement 35Labeling	Approved	None posted
Aug 17, 1989	Supplement 34Bioequivalence	Approved	None posted
Aug 17, 1989	Supplement 33Bioequivalence	Approved	None posted
Jul 11, 1989	Supplement 32Manufacturing	Approved	None posted
Jul 11, 1989	Supplement 31Manufacturing	Approved	None posted
Feb 18, 1988	Supplement 27Manufacturing	Approved	None posted
Jul 2, 1986	Supplement 26Manufacturing	Approved	None posted
Nov 23, 1984	Supplement 24Manufacturing	Approved	None posted
Jun 15, 1984	Supplement 22Manufacturing	Approved	None posted
Jan 19, 1983	Supplement 21Manufacturing	Approved	None posted
Jan 19, 1983	Supplement 20Manufacturing	Approved	None posted
May 4, 1982	Supplement 17Manufacturing	Approved	None posted
Apr 10, 1978	Original application	Approved	None posted

Identifiers

Application: ANDA 86009
Drugs@FDA: Overview at FDA
Company: Aurobindo Pharma USA

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