Amitriptyline Hydrochloride

ANDA 85970, held by Sandoz. Amitriptyline Hydrochloride.

As of Nov 15, 2026, ANDA 85970 (Amitriptyline Hydrochloride), held by Sandoz, was first approved by FDA on Nov 21, 1977, with 36 approved supplements and 0 published complete response letters.

First approved: Nov 21, 1977
Supplements approved: 36
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 37 submissions below

Date	Submission	Status	Documents
Nov 21, 1977	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Amitriptyline Hydrochloride150MG · tablet;oral	Amitriptyline Hydrochloride	Rx

All 37 submissions, including labeling and manufacturing supplements


Apr 25, 2016	Supplement 74Labeling · Standard review	Approved	None posted
Jul 17, 2014	Supplement 72Labeling · Standard review	Approved	Label
Nov 13, 2007	Supplement 65Labeling	Approved	None posted
Jun 29, 2007	Supplement 64Labeling	Approved	None posted
Jun 9, 2005	Supplement 62Labeling	Approved	None posted
Dec 16, 2002	Supplement 61Manufacturing	Approved	None posted
Jun 25, 2001	Supplement 60Labeling	Approved	None posted
Mar 23, 2001	Supplement 59Manufacturing	Approved	None posted
Aug 7, 2000	Supplement 58Labeling	Approved	None posted
May 5, 1999	Supplement 57Manufacturing	Approved	None posted
May 28, 1998	Supplement 56Manufacturing	Approved	None posted
Nov 18, 1996	Supplement 55Manufacturing	Approved	None posted
Apr 10, 1995	Supplement 54Labeling	Approved	None posted
Feb 1, 1995	Supplement 53Manufacturing	Approved	None posted
Aug 27, 1993	Supplement 52Labeling	Approved	None posted
Dec 15, 1992	Supplement 51Labeling	Approved	None posted
Jul 17, 1987	Supplement 50Manufacturing	Approved	None posted
Jul 17, 1987	Supplement 48Manufacturing	Approved	None posted
Jul 17, 1987	Supplement 45Manufacturing	Approved	None posted
Jul 17, 1987	Supplement 44Manufacturing	Approved	None posted
Jul 17, 1987	Supplement 43Manufacturing	Approved	None posted
Jul 17, 1987	Supplement 42Manufacturing	Approved	None posted
Jul 17, 1987	Supplement 41Manufacturing	Approved	None posted
Apr 27, 1987	Supplement 49Manufacturing	Approved	None posted
Jan 8, 1987	Supplement 47Manufacturing	Approved	None posted
Jan 8, 1987	Supplement 46Manufacturing	Approved	None posted
Jan 8, 1987	Supplement 40Manufacturing	Approved	None posted
Mar 22, 1985	Supplement 36Manufacturing	Approved	None posted
Mar 22, 1985	Supplement 35Manufacturing	Approved	None posted
Jan 25, 1984	Supplement 34Manufacturing	Approved	None posted
Jul 27, 1983	Supplement 32Manufacturing	Approved	None posted
Jul 27, 1983	Supplement 30Manufacturing	Approved	None posted
Jul 27, 1983	Supplement 29Manufacturing	Approved	None posted
Mar 21, 1983	Supplement 28Manufacturing	Approved	None posted
Jun 23, 1982	Supplement 27Manufacturing	Approved	None posted
Jun 23, 1982	Supplement 24Manufacturing	Approved	None posted
Nov 21, 1977	Original application	Approved	None posted

Identifiers

Application: ANDA 85970
Drugs@FDA: Overview at FDA
Company: Sandoz

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