Methadone Hydrochloride

Manages severe and persistent pain. ANDA 207537, held by Specgx LLC. Methadone Hydrochloride.

As of Nov 15, 2026, ANDA 207537 (Methadone Hydrochloride), held by Specgx LLC, was first approved by FDA on Oct 2, 2019, with 9 approved supplements and 0 published complete response letters.

First approved: Oct 2, 2019
Review: Standard
Supplements approved: 9
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Methadone hydrochloride oral solution is indicated for the: 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 oral solution, 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 10 submissions below

Date	Submission	Status	Documents
Oct 2, 2019	Original application	Approved	REMS

Products

2 strengths and forms


Methadone Hydrochloride5MG/5ML · solution;oral	Methadone Hydrochloride	Rx
Methadone Hydrochloride10MG/5ML · solution;oral	Methadone Hydrochloride	Rx

All 10 submissions, including labeling and manufacturing supplements


Jun 18, 2026	Supplement 16REMS	Approved	None posted
Dec 22, 2025	Supplement 10Labeling · Standard review	Approved	None posted
Dec 22, 2025	Supplement 14Labeling · Standard review	Approved	None posted
Oct 31, 2024	Supplement 11REMS	Approved	None posted
Jan 3, 2024	Supplement 8Labeling · Standard review	Approved	None posted
Jan 3, 2024	Supplement 9Labeling · Standard review	Approved	None posted
Jun 2, 2021	Supplement 3Labeling · Standard review	Approved	None posted
Mar 4, 2021	Supplement 2Labeling · Standard review	Approved	None posted
Feb 8, 2021	Supplement 1Labeling · Standard review	Approved	None posted
Oct 2, 2019	Original application	Approved	REMS

Identifiers

Application: ANDA 207537
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