Amitriptyline Hydrochloride

ANDA 85836, held by Teva. Amitriptyline Hydrochloride.

As of Nov 15, 2026, ANDA 85836 (Amitriptyline Hydrochloride), held by Teva, was first approved by FDA on Aug 2, 1977, with 29 approved supplements and 0 published complete response letters.

First approved: Aug 2, 1977
Supplements approved: 29
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 30 submissions below

Date	Submission	Status	Documents
Aug 2, 1977	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Amitriptyline Hydrochloride100MG · tablet;oral	Amitriptyline Hydrochloride	Discontinued

All 30 submissions, including labeling and manufacturing supplements


Jun 18, 1997	Supplement 167Manufacturing	Approved	None posted
Jul 11, 1995	Supplement 166Labeling	Approved	None posted
Feb 16, 1995	Supplement 164Manufacturing	Approved	None posted
Feb 15, 1995	Supplement 165Manufacturing	Approved	None posted
Nov 30, 1994	Supplement 163Manufacturing	Approved	None posted
Sep 6, 1994	Supplement 162Manufacturing	Approved	None posted
Jun 17, 1994	Supplement 161Manufacturing	Approved	None posted
Mar 23, 1994	Supplement 160Manufacturing	Approved	None posted
Aug 18, 1993	Supplement 159Labeling	Approved	None posted
Jun 12, 1992	Supplement 158Labeling	Approved	None posted
Jun 10, 1992	Supplement 155Manufacturing	Approved	None posted
Dec 31, 1991	Supplement 156Labeling	Approved	None posted
Apr 5, 1989	Supplement 153Manufacturing	Approved	None posted
Mar 31, 1988	Supplement 152Manufacturing	Approved	None posted
Mar 31, 1988	Supplement 151Manufacturing	Approved	None posted
Nov 4, 1987	Supplement 148Manufacturing	Approved	None posted
Sep 30, 1987	Supplement 149Manufacturing	Approved	None posted
Sep 30, 1987	Supplement 146Manufacturing	Approved	None posted
May 9, 1986	Supplement 145Manufacturing	Approved	None posted
May 9, 1986	Supplement 144Manufacturing	Approved	None posted
Mar 12, 1986	Supplement 143Manufacturing	Approved	None posted
Mar 12, 1986	Supplement 142Manufacturing	Approved	None posted
Dec 6, 1985	Supplement 140Manufacturing	Approved	None posted
Dec 6, 1985	Supplement 137Manufacturing	Approved	None posted
Sep 11, 1985	Supplement 139Manufacturing	Approved	None posted
Dec 21, 1984	Supplement 138Manufacturing	Approved	None posted
Jul 27, 1984	Supplement 136Manufacturing	Approved	None posted
Mar 15, 1984	Supplement 135Manufacturing	Approved	None posted
Jul 7, 1982	Supplement 130Manufacturing	Approved	None posted
Aug 2, 1977	Original application	Approved	None posted

Identifiers

Application: ANDA 85836
Drugs@FDA: Overview at FDA
Company: Teva 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