Amitriptyline Hydrochloride

ANDA 85820, held by Watson Labs. Amitriptyline Hydrochloride.

As of Nov 15, 2026, ANDA 85820 (Amitriptyline Hydrochloride), held by Watson Labs, was first approved by FDA on Sep 1, 1978, with 1 approved supplement and 0 published complete response letters.

First approved: Sep 1, 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
Sep 1, 1978	Original application	Approved	None posted

Products

1 strengths and forms

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

All 2 submissions, including labeling and manufacturing supplements


Mar 23, 1988	Supplement 29Labeling	Approved	None posted
Sep 1, 1978	Original application	Approved	None posted

Identifiers

Application: ANDA 85820
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