Amitriptyline Hydrochloride

ANDA 40816, held by Sun Pharm Inds Inc. Amitriptyline Hydrochloride.

As of Nov 15, 2026, ANDA 40816 (Amitriptyline Hydrochloride), held by Sun Pharm Inds Inc, was first approved by FDA on Jun 27, 2008, with 3 approved supplements and 0 published complete response letters.

First approved: Jun 27, 2008
Supplements approved: 3
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below

Date	Submission	Status	Documents
Jun 27, 2008	Original application	Approved	None posted

Products

6 strengths and forms


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

All 4 submissions, including labeling and manufacturing supplements


Jun 24, 2025	Supplement 7Labeling · Standard review	Approved	None posted
Apr 25, 2016	Supplement 6Labeling · Standard review	Approved	None posted
Jul 17, 2014	Supplement 5Labeling · Standard review	Approved	None posted
Jun 27, 2008	Original application	Approved	None posted

Identifiers

Application: ANDA 40816
Drugs@FDA: Overview at FDA
Company: Sun Pharmaceutical Industries

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