Amitriptyline Hydrochloride

Relieves symptoms of depression. ANDA 89399, held by Sun Pharm Inds Inc. Amitriptyline Hydrochloride.

As of Nov 15, 2026, ANDA 89399 (Amitriptyline Hydrochloride), held by Sun Pharm Inds Inc, was first approved by FDA on Jul 14, 1987, with 26 approved supplements and 0 published complete response letters.

First approved: Jul 14, 1987
Supplements approved: 26
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 27 submissions below

Date	Submission	Status	Documents
Jul 14, 1987	Original application	Approved	None posted

Products

6 strengths and forms


Amitriptyline Hydrochloride25MG · tablet;oral	Amitriptyline Hydrochloride	Rx
Amitriptyline Hydrochloride10MG · tablet;oral	Amitriptyline Hydrochloride	Rx
Amitriptyline Hydrochloride50MG · 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 27 submissions, including labeling and manufacturing supplements


Jun 24, 2025	Supplement 52Labeling · Standard review	Approved	None posted
Mar 19, 2019	Supplement 45Manufacturing	Approved	None posted
Apr 25, 2016	Supplement 43Labeling · Standard review	Approved	None posted
Jul 17, 2014	Supplement 39Labeling · Standard review	Approved	None posted
Nov 21, 2007	Supplement 34Labeling	Approved	None posted
Jun 29, 2007	Supplement 33Labeling	Approved	None posted
Apr 12, 2007	Supplement 32Labeling	Approved	None posted
Apr 12, 2007	Supplement 30Manufacturing	Approved	None posted
Aug 26, 2005	Supplement 26Labeling	Approved	None posted
May 5, 2005	Supplement 25Labeling	Approved	None posted
Sep 30, 2002	Supplement 17Manufacturing	Approved	None posted
Aug 7, 2001	Supplement 15Manufacturing	Approved	None posted
Aug 7, 2001	Supplement 14Manufacturing	Approved	None posted
Aug 7, 2001	Supplement 13Labeling	Approved	None posted
Jul 5, 2001	Supplement 12Manufacturing	Approved	None posted
Mar 22, 2001	Supplement 11Manufacturing	Approved	None posted
May 16, 2000	Supplement 10Manufacturing	Approved	None posted
May 16, 2000	Supplement 9Manufacturing	Approved	None posted
Dec 5, 1997	Supplement 8Manufacturing	Approved	None posted
Feb 24, 1997	Supplement 7Manufacturing	Approved	None posted
Aug 22, 1995	Supplement 6Labeling	Approved	None posted
Jun 22, 1995	Supplement 5Manufacturing	Approved	None posted
Jan 12, 1994	Supplement 4Manufacturing	Approved	None posted
Aug 16, 1993	Supplement 3Labeling	Approved	None posted
May 15, 1992	Supplement 2Labeling	Approved	None posted
Feb 27, 1992	Supplement 1Manufacturing	Approved	None posted
Jul 14, 1987	Original application	Approved	None posted

Identifiers

Application: ANDA 89399
Drugs@FDA: Overview at FDA
Company: Sun Pharmaceutical Industries

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