Methadone Hydrochloride

Treats opioid addiction (heroin or other morphine-like drugs). ANDA 40088, held by Vistapharm LLC. Methadone Hydrochloride.

As of Nov 15, 2026, ANDA 40088 (Methadone Hydrochloride), held by Vistapharm LLC, was first approved by FDA on Nov 30, 1994, with 12 approved supplements and 0 published complete response letters.

First approved: Nov 30, 1994
Supplements approved: 12
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Methadone hydrochloride oral concentrate contains 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 21 CFR, Title 42, Sec 8.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 13 submissions below

Date	Submission	Status	Documents
Nov 30, 1994	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Methadone Hydrochloride10MG/ML · concentrate;oral	Methadone Hydrochloride	Rx

All 13 submissions, including labeling and manufacturing supplements


Sep 14, 2026	Supplement 33Labeling · Standard review	Approved	None posted
Jan 30, 2025	Supplement 29Manufacturing	Approved	None posted
Jun 18, 2024	Supplement 28Labeling · Standard review	Approved	None posted
Dec 14, 2022	Supplement 20Labeling · Standard review	Approved	None posted
Dec 14, 2022	Supplement 18Labeling · Standard review	Approved	None posted
Dec 14, 2022	Supplement 15Labeling · Standard review	Approved	None posted
Dec 14, 2022	Supplement 11Labeling · Standard review	Approved	None posted
Dec 14, 2022	Supplement 10Labeling · Standard review	Approved	None posted
Oct 21, 2011	Supplement 8Manufacturing	Approved	None posted
Sep 27, 2002	Supplement 2Manufacturing	Approved	None posted
Mar 13, 2002	Supplement 3Labeling	Approved	None posted
Dec 6, 2001	Supplement 1Manufacturing	Approved	None posted
Nov 30, 1994	Original application	Approved	None posted

Identifiers

Application: ANDA 40088
Drugs@FDA: Overview at FDA
Company: VistaPharm

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