Methadone Hydrochloride

Manages severe and persistent pain. ANDA 88109, held by Hikma. Methadone Hydrochloride.

As of Nov 15, 2026, ANDA 88109 (Methadone Hydrochloride), held by Hikma, was first approved by FDA on Mar 8, 1983, with 22 approved supplements and 0 published complete response letters.

First approved: Mar 8, 1983
Supplements approved: 22
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 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 Tablets, 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 23 submissions below

Date	Submission	Status	Documents
Mar 8, 1983	Original application	Approved	REMS

Products

2 strengths and forms


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

All 23 submissions, including labeling and manufacturing supplements


Jun 18, 2026	Supplement 29REMS	Approved	None posted
Dec 22, 2025	Supplement 26Labeling · Standard review	Approved	None posted
Jun 25, 2025	Supplement 23Labeling · Standard review	Approved	None posted
Oct 31, 2024	Supplement 24REMS	Approved	None posted
Dec 15, 2023	Supplement 22Labeling · Standard review	Approved	None posted
Jun 2, 2021	Supplement 21Labeling · Standard review	Approved	None posted
May 5, 2020	Supplement 20REMS	Approved	None posted
Apr 1, 1998	Supplement 18Manufacturing	Approved	None posted
Apr 1, 1998	Supplement 17Manufacturing	Approved	None posted
Apr 1, 1998	Supplement 12Manufacturing	Approved	None posted
Apr 1, 1998	Supplement 11Manufacturing	Approved	None posted
Aug 28, 1996	Supplement 15Manufacturing	Approved	None posted
Aug 27, 1996	Supplement 16Manufacturing	Approved	None posted
Aug 25, 1995	Supplement 14Manufacturing	Approved	None posted
May 19, 1995	Supplement 13Labeling	Approved	None posted
May 12, 1992	Supplement 10Labeling	Approved	None posted
Jul 31, 1991	Supplement 9Manufacturing	Approved	None posted
Feb 26, 1990	Supplement 7Labeling	Approved	None posted
Sep 2, 1988	Supplement 5Manufacturing	Approved	None posted
Sep 2, 1988	Supplement 4Manufacturing	Approved	None posted
Sep 2, 1988	Supplement 1Bioequivalence	Approved	None posted
Oct 21, 1987	Supplement 3Labeling	Approved	None posted
Mar 8, 1983	Original application	Approved	REMS

Identifiers

Application: ANDA 88109
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