Methadone Hydrochloride

Treats opioid addiction (heroin or other morphine-like drugs). NDA 17058, held by Hikma. Methadone Hydrochloride.

As of Nov 14, 2026, NDA 17058 (Methadone Hydrochloride), held by Hikma, was first approved by FDA on Mar 14, 1973, with 22 approved supplements and 0 published complete response letters.

First approved: Mar 14, 1973
Review: Standard
Supplements approved: 22
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

DISKETS Dispersible Tablets contain methadone, an opioid agonist indicated for the:

Detoxification treatment of opioid addiction (heroin or other morphine-like drugs).
Maintenance treatment of opioid addiction (heroin or other morphine-like drugs), in conjunction with appropriate social and medical services. Limitations of Use Methadone products used for the treatment of opioid addiction in detoxification or maintenance programs are subject to the conditions for distribution and use required under 42 CFR 8.12.

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 14, 1973	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Methadone Hydrochloride40MG · tablet, for suspension;oral	Methadone Hydrochloride	RxReference drug

All 23 submissions, including labeling and manufacturing supplements


Dec 22, 2025	Supplement 29Labeling · Standard review	Approved	Label Letter
Dec 15, 2023	Supplement 28Labeling · Standard review	Approved	Letter Label
Jun 2, 2021	Supplement 27Labeling · Standard review	Approved	Letter Label
Oct 7, 2019	Supplement 26Labeling · Standard review	Approved	Label Letter
Feb 1, 2018	Supplement 25Labeling · Standard review	Approved	Letter Label
Dec 16, 2016	Supplement 23Labeling · Standard review	Approved	Label Letter
Dec 16, 2016	Supplement 22Labeling · Standard review	Approved	Label Letter
Aug 24, 2015	Supplement 20Manufacturing · Standard review	Approved	None posted
Sep 19, 2013	Supplement 21Labeling	Approved	Label Letter
Feb 4, 2008	Supplement 19Labeling · Standard review	Approved	Label Letter
Dec 7, 2006	Supplement 17Labeling · Standard review	Approved	Letter Label
Sep 18, 2000	Supplement 15Manufacturing · Standard review	Approved	None posted
Mar 30, 1999	Supplement 14Manufacturing · Standard review	Approved	None posted
Sep 22, 1998	Supplement 13Manufacturing · Standard review	Approved	None posted
Sep 28, 1995	Supplement 12Manufacturing · Standard review	Approved	None posted
Oct 31, 1986	Supplement 8Manufacturing · Standard review	Approved	None posted
Oct 10, 1986	Supplement 7Manufacturing · Standard review	Approved	None posted
Jan 28, 1986	Supplement 6Labeling	Approved	None posted
Apr 25, 1985	Supplement 5Manufacturing · Standard review	Approved	None posted
Mar 25, 1980	Supplement 3Manufacturing · Standard review	Approved	None posted
Mar 25, 1977	Supplement 2Labeling	Approved	None posted
May 4, 1976	Supplement 1Labeling	Approved	None posted
Mar 14, 1973	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 17058
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