Amitriptyline Hydrochloride

ANDA 88885, held by Pliva. Amitriptyline Hydrochloride.

As of Nov 15, 2026, ANDA 88885 (Amitriptyline Hydrochloride), held by Pliva, was first approved by FDA on Sep 26, 1984, with 13 approved supplements and 0 published complete response letters.

First approved: Sep 26, 1984
Supplements approved: 13
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 14 submissions below

Date	Submission	Status	Documents
Sep 26, 1984	Original application	Approved	None posted

Products

1 strengths and forms

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

All 14 submissions, including labeling and manufacturing supplements


Jun 25, 2001	Supplement 17Labeling	Approved	None posted
Oct 5, 2000	Supplement 15Labeling	Approved	None posted
Jul 7, 2000	Supplement 14Manufacturing	Approved	None posted
Jul 14, 1995	Supplement 12Labeling	Approved	None posted
May 24, 1995	Supplement 13Labeling	Approved	None posted
May 11, 1994	Supplement 11Manufacturing	Approved	None posted
Nov 4, 1993	Supplement 10Labeling	Approved	None posted
May 26, 1992	Supplement 9Labeling	Approved	None posted
Jul 29, 1991	Supplement 6Manufacturing	Approved	None posted
Mar 22, 1988	Supplement 5Manufacturing	Approved	None posted
Jun 17, 1985	Supplement 3Manufacturing	Approved	None posted
Jun 17, 1985	Supplement 2Manufacturing	Approved	None posted
Jun 17, 1985	Supplement 1Manufacturing	Approved	None posted
Sep 26, 1984	Original application	Approved	None posted

Identifiers

Application: ANDA 88885
Drugs@FDA: Overview at FDA
Company: PLIVA

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