Methadone Hydrochloride

Manages severe and persistent pain. ANDA 87393, held by Hikma. Methadone Hydrochloride.

As of Nov 15, 2026, ANDA 87393 (Methadone Hydrochloride), held by Hikma, was first approved by FDA on May 22, 1981, with 41 approved supplements and 0 published complete response letters.

First approved: May 22, 1981
Supplements approved: 41
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 42 submissions below

Date	Submission	Status	Documents
May 22, 1981	Original application	Approved	Other

Products

1 strengths and forms

Product	Active ingredient	Marketing
Methadone Hydrochloride5MG/5ML · solution;oral	Methadone Hydrochloride	RxReference drug

All 42 submissions, including labeling and manufacturing supplements


Jun 18, 2026	Supplement 55REMS	Approved	None posted
Dec 22, 2025	Supplement 54Labeling · Standard review	Approved	None posted
Dec 22, 2025	Supplement 52Labeling · Standard review	Approved	None posted
Oct 31, 2024	Supplement 53REMS	Approved	None posted
Dec 15, 2023	Supplement 51Labeling · Standard review	Approved	None posted
Jun 2, 2021	Supplement 49Labeling · Standard review	Approved	None posted
Oct 9, 2019	Supplement 48Labeling · Standard review	Approved	None posted
Sep 21, 2018	Supplement 47Labeling · Standard review	Approved	None posted
Sep 18, 2018	Supplement 46REMS	Approved	None posted
Feb 1, 2018	Supplement 45Labeling · Standard review	Approved	None posted
Jan 31, 2018	Supplement 44Labeling · Standard review	Approved	None posted
May 26, 2017	Supplement 43REMS	Approved	None posted
Dec 16, 2016	Supplement 40Labeling · Standard review	Approved	None posted
Dec 16, 2016	Supplement 39Labeling · Standard review	Approved	None posted
Dec 15, 2016	Supplement 37Labeling · Standard review	Approved	None posted
Sep 30, 2016	Supplement 41REMS	Approved	None posted
Apr 20, 2016	Supplement 38REMS	Approved	None posted
Jun 26, 2015	Supplement 36REMS	Approved	None posted
Aug 19, 2014	Supplement 35REMS	Approved	None posted
Apr 16, 2014	Supplement 33Labeling · Standard review	Approved	Label
Apr 15, 2013	Supplement 32REMS	Approved	None posted
Jul 9, 2012	Supplement 31REMS	Approved	None posted
Jul 9, 2012	Supplement 30Labeling	Approved	None posted
Jan 2, 2008	Supplement 28Labeling	Approved	None posted
Jun 7, 2007	Supplement 27Labeling	Approved	None posted
Nov 17, 1999	Supplement 24Manufacturing	Approved	None posted
Nov 17, 1999	Supplement 23Manufacturing	Approved	None posted
Feb 17, 1999	Supplement 22Manufacturing	Approved	None posted
Feb 17, 1999	Supplement 18Manufacturing	Approved	None posted
Mar 9, 1998	Supplement 21Manufacturing	Approved	None posted
Mar 9, 1998	Supplement 20Manufacturing	Approved	None posted
Mar 9, 1998	Supplement 19Manufacturing	Approved	None posted
Aug 28, 1996	Supplement 17Manufacturing	Approved	None posted
Jul 17, 1991	Supplement 9Manufacturing	Approved	None posted
May 10, 1991	Supplement 16Labeling	Approved	None posted
Apr 2, 1991	Supplement 14Labeling	Approved	None posted
Feb 23, 1988	Supplement 8Manufacturing	Approved	None posted
Nov 4, 1987	Supplement 5Manufacturing	Approved	None posted
Nov 4, 1987	Supplement 4Manufacturing	Approved	None posted
Nov 4, 1987	Supplement 3Manufacturing	Approved	None posted
Aug 6, 1984	Supplement 2Manufacturing	Approved	None posted
May 22, 1981	Original application	Approved	Other

Identifiers

Application: ANDA 87393
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