Amitriptyline Hydrochloride

ANDA 85815, held by Watson Labs. Amitriptyline Hydrochloride.

As of Nov 15, 2026, ANDA 85815 (Amitriptyline Hydrochloride), held by Watson Labs, was first approved by FDA on May 11, 1978, with 3 approved supplements and 0 published complete response letters.

First approved: May 11, 1978
Supplements approved: 3
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below

Date	Submission	Status	Documents
May 11, 1978	Original application	Approved	None posted

Products

1 strengths and forms

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

All 4 submissions, including labeling and manufacturing supplements


Jun 28, 1993	Supplement 34Labeling	Approved	None posted
Dec 17, 1991	Supplement 33Labeling	Approved	None posted
Mar 23, 1988	Supplement 30Labeling	Approved	None posted
May 11, 1978	Original application	Approved	None posted

Identifiers

Application: ANDA 85815
Drugs@FDA: Overview at FDA
Company: Watson Laboratories

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