Amitriptyline Hydrochloride

ANDA 85032, held by Ani Pharms Inc. Amitriptyline Hydrochloride.

As of Nov 15, 2026, ANDA 85032 (Amitriptyline Hydrochloride), held by Ani Pharms Inc, was first approved by FDA on Nov 19, 1976, with 34 approved supplements and 0 published complete response letters.

First approved: Nov 19, 1976
Supplements approved: 34
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 35 submissions below

Date	Submission	Status	Documents
Nov 19, 1976	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Amitriptyline Hydrochloride50MG · tablet;oral	Amitriptyline Hydrochloride	Discontinued

All 35 submissions, including labeling and manufacturing supplements


Apr 25, 2016	Supplement 309Labeling · Standard review	Approved	None posted
Nov 17, 2014	Supplement 308Labeling · Standard review	Approved	None posted
Jun 18, 1997	Supplement 307Manufacturing	Approved	None posted
Jul 11, 1995	Supplement 306Labeling	Approved	None posted
Feb 16, 1995	Supplement 304Manufacturing	Approved	None posted
Feb 15, 1995	Supplement 305Manufacturing	Approved	None posted
Nov 30, 1994	Supplement 303Manufacturing	Approved	None posted
Sep 6, 1994	Supplement 302Manufacturing	Approved	None posted
Jun 17, 1994	Supplement 301Manufacturing	Approved	None posted
Mar 23, 1994	Supplement 300Manufacturing	Approved	None posted
Aug 18, 1993	Supplement 299Labeling	Approved	None posted
Jun 12, 1992	Supplement 298Labeling	Approved	None posted
Jun 10, 1992	Supplement 294Manufacturing	Approved	None posted
Dec 31, 1991	Supplement 295Labeling	Approved	None posted
Apr 5, 1989	Supplement 293Manufacturing	Approved	None posted
Apr 5, 1989	Supplement 292Manufacturing	Approved	None posted
Mar 31, 1988	Supplement 290Manufacturing	Approved	None posted
Nov 4, 1987	Supplement 287Manufacturing	Approved	None posted
Sep 30, 1987	Supplement 288Manufacturing	Approved	None posted
Sep 30, 1987	Supplement 285Manufacturing	Approved	None posted
Sep 30, 1987	Supplement 280Manufacturing	Approved	None posted
Apr 28, 1986	Supplement 284Manufacturing	Approved	None posted
Apr 28, 1986	Supplement 283Manufacturing	Approved	None posted
Mar 12, 1986	Supplement 282Manufacturing	Approved	None posted
Mar 12, 1986	Supplement 281Manufacturing	Approved	None posted
Dec 6, 1985	Supplement 279Manufacturing	Approved	None posted
Dec 6, 1985	Supplement 275Manufacturing	Approved	None posted
Sep 11, 1985	Supplement 278Manufacturing	Approved	None posted
Dec 21, 1984	Supplement 276Manufacturing	Approved	None posted
Jul 27, 1984	Supplement 274Manufacturing	Approved	None posted
Mar 15, 1984	Supplement 273Manufacturing	Approved	None posted
Dec 16, 1983	Supplement 271Manufacturing	Approved	None posted
Dec 12, 1983	Supplement 263Manufacturing	Approved	None posted
Feb 28, 1983	Supplement 270Manufacturing	Approved	None posted
Nov 19, 1976	Original application	Approved	None posted

Identifiers

Application: ANDA 85032
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