Amitriptyline Hydrochloride

ANDA 218389, held by Unique Pharm. Amitriptyline Hydrochloride.

As of Nov 15, 2026, ANDA 218389 (Amitriptyline Hydrochloride), held by Unique Pharm, was first approved by FDA on Jun 23, 2025, with 1 approved supplement and 0 published complete response letters.

First approved: Jun 23, 2025
Review: Standard
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
Jun 23, 2025	Original application	Approved	None posted

Products

6 strengths and forms


Amitriptyline Hydrochloride10MG · tablet;oral	Amitriptyline Hydrochloride	Rx
Amitriptyline Hydrochloride25MG · tablet;oral	Amitriptyline Hydrochloride	Rx
Amitriptyline Hydrochloride50MG · tablet;oral	Amitriptyline Hydrochloride	Rx
Amitriptyline Hydrochloride75MG · tablet;oral	Amitriptyline Hydrochloride	Rx
Amitriptyline Hydrochloride100MG · tablet;oral	Amitriptyline Hydrochloride	Rx
Amitriptyline Hydrochloride150MG · tablet;oral	Amitriptyline Hydrochloride	Rx

All 2 submissions, including labeling and manufacturing supplements


Jan 9, 2026	Supplement 1Labeling · Standard review	Approved	None posted
Jun 23, 2025	Original application	Approved	None posted

Identifiers

Application: ANDA 218389
Drugs@FDA: Overview at FDA
Company: Unique Pharmaceutical 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