Methadone Hydrochloride

Manages severe and persistent pain. ANDA 87997, held by Hikma. Methadone Hydrochloride.

As of Nov 15, 2026, ANDA 87997 (Methadone Hydrochloride), held by Hikma, was first approved by FDA on Aug 30, 1982, with 37 approved supplements and 0 published complete response letters.

First approved: Aug 30, 1982
Supplements approved: 37
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 38 submissions below

Date	Submission	Status	Documents
Aug 30, 1982	Original application	Approved	Other

Products

1 strengths and forms

Product	Active ingredient	Marketing
Methadone Hydrochloride10MG/5ML · solution;oral	Methadone Hydrochloride	RxReference drug

All 38 submissions, including labeling and manufacturing supplements


Jun 18, 2026	Supplement 47REMS	Approved	None posted
Dec 22, 2025	Supplement 46Labeling · Standard review	Approved	None posted
Dec 22, 2025	Supplement 44Labeling · Standard review	Approved	None posted
Oct 31, 2024	Supplement 45REMS	Approved	None posted
Dec 15, 2023	Supplement 43Labeling · Standard review	Approved	None posted
Jun 2, 2021	Supplement 41Labeling · Standard review	Approved	None posted
Oct 9, 2019	Supplement 40Labeling · Standard review	Approved	None posted
Sep 21, 2018	Supplement 39Labeling · Standard review	Approved	None posted
Sep 18, 2018	Supplement 38REMS	Approved	None posted
Feb 1, 2018	Supplement 37Labeling · Standard review	Approved	None posted
Jan 31, 2018	Supplement 36Labeling · Standard review	Approved	None posted
May 26, 2017	Supplement 35REMS	Approved	None posted
Mar 10, 2017	Supplement 33Labeling · Standard review	Approved	None posted
Dec 16, 2016	Supplement 31Labeling · Standard review	Approved	None posted
Dec 16, 2016	Supplement 30Labeling · Standard review	Approved	None posted
Dec 15, 2016	Supplement 28Labeling · Standard review	Approved	None posted
Sep 30, 2016	Supplement 32REMS	Approved	None posted
Apr 20, 2016	Supplement 29REMS	Approved	None posted
Jun 26, 2015	Supplement 27REMS	Approved	None posted
Aug 19, 2014	Supplement 26REMS	Approved	None posted
Apr 16, 2014	Supplement 24Labeling · Standard review	Approved	Label
Apr 15, 2013	Supplement 23REMS	Approved	None posted
Jul 9, 2012	Supplement 22REMS	Approved	None posted
Jul 9, 2012	Supplement 21Labeling	Approved	None posted
Jan 2, 2008	Supplement 19Labeling	Approved	None posted
Jun 7, 2007	Supplement 18Labeling	Approved	None posted
Feb 1, 2000	Supplement 15Manufacturing	Approved	None posted
Mar 3, 1999	Supplement 14Manufacturing	Approved	None posted
Mar 3, 1999	Supplement 12Manufacturing	Approved	None posted
Mar 2, 1998	Supplement 13Manufacturing	Approved	None posted
Mar 2, 1998	Supplement 11Manufacturing	Approved	None posted
Mar 2, 1998	Supplement 10Manufacturing	Approved	None posted
Aug 28, 1996	Supplement 9Manufacturing	Approved	None posted
Jan 31, 1994	Supplement 4Manufacturing	Approved	None posted
Dec 24, 1991	Supplement 8Labeling	Approved	None posted
Dec 24, 1991	Supplement 5Labeling	Approved	None posted
Feb 4, 1988	Supplement 3Manufacturing	Approved	None posted
Aug 30, 1982	Original application	Approved	Other

Identifiers

Application: ANDA 87997
Drugs@FDA: Overview at FDA
Company: Hikma

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