Amitriptyline Hydrochloride

ANDA 86090, held by Roxane. Amitriptyline Hydrochloride.

As of Nov 15, 2026, ANDA 86090 (Amitriptyline Hydrochloride), held by Roxane, was first approved by FDA on Oct 28, 1977, with 4 approved supplements and 0 published complete response letters.

First approved: Oct 28, 1977
Supplements approved: 4
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 5 submissions below

Date	Submission	Status	Documents
Oct 28, 1977	Original application	Approved	None posted

Products

1 strengths and forms

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

All 5 submissions, including labeling and manufacturing supplements


Aug 24, 1993	Supplement 28Labeling	Approved	None posted
Mar 11, 1993	Supplement 27Labeling	Approved	None posted
Apr 26, 1991	Supplement 26Labeling	Approved	None posted
Mar 30, 1988	Supplement 21Labeling	Approved	None posted
Oct 28, 1977	Original application	Approved	None posted

Identifiers

Application: ANDA 86090
Drugs@FDA: Overview at FDA
Company: Roxane 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