Amitriptyline Hydrochloride

ANDA 85031, held by Ani Pharms. Amitriptyline Hydrochloride.

As of Nov 15, 2026, ANDA 85031 (Amitriptyline Hydrochloride), held by Ani Pharms, was first approved by FDA on Nov 16, 1976, with 37 approved supplements and 0 published complete response letters.

First approved: Nov 16, 1976
Supplements approved: 37
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 38 submissions below

Date	Submission	Status	Documents
Nov 16, 1976	Original application	Approved	None posted

Products

4 strengths and forms


Amitriptyline Hydrochloride25MG · tablet;oral	Amitriptyline Hydrochloride	Discontinued
Amitriptyline Hydrochloride10MG · tablet;oral	Amitriptyline Hydrochloride	Discontinued
Amitriptyline Hydrochloride50MG · tablet;oral	Amitriptyline Hydrochloride	Discontinued
Amitriptyline Hydrochloride75MG · tablet;oral	Amitriptyline Hydrochloride	Discontinued

All 38 submissions, including labeling and manufacturing supplements


Jun 24, 2025	Supplement 289Labeling · Standard review	Approved	None posted
Jun 16, 2025	Supplement 288Labeling · Standard review	Approved	None posted
Apr 25, 2016	Supplement 287Labeling · Standard review	Approved	None posted
Nov 17, 2014	Supplement 286Labeling · Standard review	Approved	None posted
Jun 18, 1997	Supplement 285Manufacturing	Approved	None posted
Jun 11, 1995	Supplement 284Labeling	Approved	None posted
Feb 16, 1995	Supplement 282Manufacturing	Approved	None posted
Feb 15, 1995	Supplement 283Manufacturing	Approved	None posted
Nov 30, 1994	Supplement 281Manufacturing	Approved	None posted
Sep 6, 1994	Supplement 280Manufacturing	Approved	None posted
Jun 17, 1994	Supplement 279Manufacturing	Approved	None posted
Mar 23, 1994	Supplement 278Manufacturing	Approved	None posted
Aug 18, 1993	Supplement 277Labeling	Approved	None posted
Jun 12, 1992	Supplement 276Labeling	Approved	None posted
Jun 10, 1992	Supplement 272Manufacturing	Approved	None posted
Dec 31, 1991	Supplement 273Labeling	Approved	None posted
Apr 5, 1989	Supplement 271Manufacturing	Approved	None posted
Mar 31, 1988	Supplement 269Manufacturing	Approved	None posted
Mar 31, 1988	Supplement 268Manufacturing	Approved	None posted
Nov 4, 1987	Supplement 265Manufacturing	Approved	None posted
Sep 30, 1987	Supplement 266Manufacturing	Approved	None posted
Sep 30, 1987	Supplement 263Manufacturing	Approved	None posted
Apr 28, 1986	Supplement 262Manufacturing	Approved	None posted
Apr 28, 1986	Supplement 261Manufacturing	Approved	None posted
Mar 12, 1986	Supplement 260Manufacturing	Approved	None posted
Mar 12, 1986	Supplement 259Manufacturing	Approved	None posted
Dec 19, 1985	Supplement 257Manufacturing	Approved	None posted
Dec 6, 1985	Supplement 256Manufacturing	Approved	None posted
Dec 6, 1985	Supplement 255Manufacturing	Approved	None posted
Dec 6, 1985	Supplement 251Manufacturing	Approved	None posted
Sep 11, 1985	Supplement 254Manufacturing	Approved	None posted
Dec 21, 1984	Supplement 252Manufacturing	Approved	None posted
Jul 27, 1984	Supplement 250Manufacturing	Approved	None posted
Mar 15, 1984	Supplement 249Manufacturing	Approved	None posted
Dec 16, 1983	Supplement 248Manufacturing	Approved	None posted
Dec 12, 1983	Supplement 239Manufacturing	Approved	None posted
Jun 18, 1982	Supplement 244Manufacturing	Approved	None posted
Nov 16, 1976	Original application	Approved	None posted

Identifiers

Application: ANDA 85031
Drugs@FDA: Overview at FDA
Company: ANI Pharmaceuticals

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