Methadone Hydrochloride

Manages severe and persistent pain. ANDA 211228, held by Ascent Pharms Inc. Methadone Hydrochloride.

As of Nov 15, 2026, ANDA 211228 (Methadone Hydrochloride), held by Ascent Pharms Inc, was first approved by FDA on Jan 3, 2019, with 8 approved supplements and 0 published complete response letters.

First approved: Jan 3, 2019
Review: Standard
Supplements approved: 8
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 extended treatment period with a daily opioid analgesic and for which alternative treatment options are inadequate. Limitations of Use Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration, reserve methadone hydrochloride tablets for use in patients for whom alternative analgesic treatment options (e.g., non-opioid analgesics or opioid combination products) 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
Jan 3, 2019	Original application	Approved	REMS

Products

2 strengths and forms


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

All 9 submissions, including labeling and manufacturing supplements


Jun 18, 2026	Supplement 10REMS	Approved	None posted
Dec 22, 2025	Supplement 5Labeling · Standard review	Approved	None posted
Dec 22, 2025	Supplement 9Labeling · Standard review	Approved	None posted
Oct 31, 2024	Supplement 6REMS	Approved	None posted
Dec 15, 2023	Supplement 3Labeling · Standard review	Approved	None posted
Dec 15, 2023	Supplement 4Labeling · Standard review	Approved	None posted
Jun 2, 2021	Supplement 2Labeling · Standard review	Approved	None posted
Feb 19, 2021	Supplement 1Labeling · Standard review	Approved	None posted
Jan 3, 2019	Original application	Approved	REMS

Identifiers

Application: ANDA 211228
Drugs@FDA: Overview at FDA
Company: Ascent Pharmaceuticals, Inc.

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