Methadone Hydrochloride

Manages severe and persistent pain. ANDA 203502, held by Aurolife Pharma LLC. Methadone Hydrochloride.

As of Nov 15, 2026, ANDA 203502 (Methadone Hydrochloride), held by Aurolife Pharma LLC, was first approved by FDA on Aug 31, 2015, with 13 approved supplements and 0 published complete response letters.

First approved: Aug 31, 2015
Supplements approved: 13
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Methadone Hydrochloride Tablets are indicated forthe: 1. Management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids. 2. Limitations of Use Because of the risks of addiction, abuse, and misuse overdose, and death, which can occur at any dosage or duration and persist over the course of therapy, reserve opioid analgesics, including Methadone Hydrochloride Tablets, for use in patients for whom alternative analgesic treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 14 submissions below

Date	Submission	Status	Documents
Aug 31, 2015	Original application	Approved	REMS

Products

2 strengths and forms


Methadone Hydrochloride5MG · tablet;oral	Methadone Hydrochloride	Rx
Methadone Hydrochloride10MG · tablet;oral	Methadone Hydrochloride	Rx

All 14 submissions, including labeling and manufacturing supplements


Jun 18, 2026	Supplement 14REMS	Approved	None posted
Dec 22, 2025	Supplement 13Labeling · Standard review	Approved	None posted
Oct 31, 2024	Supplement 12REMS	Approved	None posted
Mar 19, 2024	Supplement 11Labeling · Standard review	Approved	None posted
Mar 18, 2024	Supplement 9Labeling · Standard review	Approved	None posted
Mar 18, 2024	Supplement 10Labeling · Standard review	Approved	None posted
Jun 2, 2021	Supplement 8Labeling · Standard review	Approved	None posted
Feb 18, 2021	Supplement 4Labeling · Standard review	Approved	None posted
Feb 18, 2021	Supplement 7Labeling · Standard review	Approved	None posted
Sep 18, 2018	Supplement 5REMS	Approved	None posted
May 26, 2017	Supplement 3REMS	Approved	None posted
Sep 30, 2016	Supplement 2REMS	Approved	None posted
Apr 20, 2016	Supplement 1REMS	Approved	None posted
Aug 31, 2015	Original application	Approved	REMS

Identifiers

Application: ANDA 203502
Drugs@FDA: Overview at FDA
Company: Aurolife Pharma

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