Methadone Hydrochloride

Manages severe and persistent pain. NDA 21624, held by Mylan Institutional. Methadone Hydrochloride.

As of Nov 14, 2026, NDA 21624 (Methadone Hydrochloride), held by Mylan Institutional, was first approved by FDA on Aug 13, 1947, with 8 approved supplements and 0 published complete response letters.

First approved: Aug 13, 1947
Supplements approved: 8
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE 1. Methadone Hydrochloride Injection 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 (see WARNINGS ), and persist over the course of therapy, reserve opioid analgesics, including Methadone Hydrochloride Injection, 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 9 submissions below

Date	Submission	Status	Documents
Aug 13, 1947	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Methadone Hydrochloride10MG/ML · injectable;injection	Methadone Hydrochloride	RxReference drug

All 9 submissions, including labeling and manufacturing supplements


Dec 22, 2025	Supplement 18Labeling · Standard review	Approved	Label Letter
Dec 15, 2023	Supplement 16Labeling · Standard review	Approved	Letter Label
May 24, 2022	Supplement 15Labeling · Standard review	Approved	Label Letter
Jun 2, 2021	Supplement 14Labeling · Standard review	Approved	Letter Label
Oct 7, 2019	Supplement 10Labeling · Standard review	Approved	Label
Dec 16, 2016	Supplement 6Labeling · Standard review	Approved	Label Letter
Jun 26, 2013	Supplement 5Manufacturing	Approved	None posted
Feb 12, 2004	Supplement 1Labeling · Standard review	Approved	Review Label Letter
Aug 13, 1947	Original application	Approved	None posted

Identifiers

Application: NDA 21624
Drugs@FDA: Overview at FDA
Company: Mylan Institutional

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