Amitriptyline Hydrochloride

ANDA 85816, held by Watson Labs. Amitriptyline Hydrochloride.

As of Nov 15, 2026, ANDA 85816 (Amitriptyline Hydrochloride), held by Watson Labs, was first approved by FDA on Aug 15, 1978, with 1 approved supplement and 0 published complete response letters.

First approved: Aug 15, 1978
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Aug 15, 1978	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Amitriptyline Hydrochloride10MG · tablet;oral	Amitriptyline Hydrochloride	Discontinued

All 2 submissions, including labeling and manufacturing supplements


Mar 23, 1988	Supplement 28Labeling	Approved	None posted
Aug 15, 1978	Original application	Approved	None posted

Identifiers

Application: ANDA 85816
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