Amitriptyline Hydrochloride

ANDA 86148, held by Roxane. Amitriptyline Hydrochloride.

As of Nov 15, 2026, ANDA 86148 (Amitriptyline Hydrochloride), held by Roxane, was first approved by FDA on Jan 23, 1978, with 1 approved supplement and 0 published complete response letters.

First approved: Jan 23, 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
Jan 23, 1978	Original application	Approved	None posted

Products

1 strengths and forms

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

All 2 submissions, including labeling and manufacturing supplements


Jan 13, 1984	Supplement 10Manufacturing	Approved	None posted
Jan 23, 1978	Original application	Approved	None posted

Identifiers

Application: ANDA 86148
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