Methadone Hydrochloride

Manages severe and persistent pain. ANDA 40517, held by Specgx LLC. Methadone Hydrochloride.

As of Nov 15, 2026, ANDA 40517 (Methadone Hydrochloride), held by Specgx LLC, was first approved by FDA on Apr 27, 2004, with 27 approved supplements and 0 published complete response letters.

First approved: Apr 27, 2004
Supplements approved: 27
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Methadone hydrochloride tablets are indicated for the: 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. Limitations of Use: Because of the risks of addiction, abuse, 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 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 28 submissions below

Date	Submission	Status	Documents
Apr 27, 2004	Original application	Approved	Other

Products

2 strengths and forms


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

All 28 submissions, including labeling and manufacturing supplements


Jun 18, 2026	Supplement 42REMS	Approved	None posted
Dec 22, 2025	Supplement 40Labeling · Standard review	Approved	None posted
Dec 22, 2025	Supplement 38Labeling · Standard review	Approved	None posted
Oct 31, 2024	Supplement 39REMS	Approved	None posted
Jan 3, 2024	Supplement 37Labeling · Standard review	Approved	None posted
Jan 3, 2024	Supplement 36Labeling · Standard review	Approved	None posted
Dec 31, 2023	Supplement 35Labeling · Standard review	Approved	None posted
Mar 16, 2022	Supplement 28Labeling · Standard review	Approved	None posted
Mar 16, 2022	Supplement 26Labeling · Standard review	Approved	None posted
Mar 16, 2022	Supplement 24Labeling · Standard review	Approved	None posted
Mar 16, 2022	Supplement 23Labeling · Standard review	Approved	None posted
Jun 2, 2021	Supplement 30Labeling · Standard review	Approved	None posted
Sep 18, 2018	Supplement 25REMS	Approved	None posted
May 26, 2017	Supplement 22REMS	Approved	None posted
Oct 28, 2016	Supplement 19Labeling · Standard review	Approved	None posted
Sep 30, 2016	Supplement 20REMS	Approved	None posted
Apr 20, 2016	Supplement 18REMS	Approved	None posted
Jun 26, 2015	Supplement 15REMS	Approved	None posted
Jun 1, 2015	Supplement 16Labeling · Standard review	Approved	None posted
Aug 19, 2014	Supplement 14REMS	Approved	None posted
Jul 23, 2014	Supplement 12Labeling · Standard review	Approved	None posted
Apr 15, 2013	Supplement 9REMS	Approved	None posted
Jul 9, 2012	Supplement 8Labeling	Approved	None posted
Jul 9, 2012	Supplement 7REMS	Approved	None posted
Jan 26, 2008	Supplement 4Manufacturing	Approved	None posted
Jan 10, 2007	Supplement 3Labeling	Approved	None posted
Mar 2, 2006	Supplement 2Labeling	Approved	None posted
Apr 27, 2004	Original application	Approved	Other

Identifiers

Application: ANDA 40517
Drugs@FDA: Overview at FDA
Company: SpecGx

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