Methadone Hydrochloride

Treats opioid addiction (heroin or other morphine-like drugs). ANDA 75082, held by Vistapharm LLC. Methadone Hydrochloride.

As of Nov 15, 2026, ANDA 75082 (Methadone Hydrochloride), held by Vistapharm LLC, was first approved by FDA on Mar 25, 1998, with 10 approved supplements and 0 published complete response letters.

First approved: Mar 25, 1998
Supplements approved: 10
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Methadone hydrochloride tablets for oral suspension 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 11 submissions below

Date	Submission	Status	Documents
Mar 25, 1998	Original application	Approved	Review

Products

1 strengths and forms

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

All 11 submissions, including labeling and manufacturing supplements


Aug 27, 2024	Supplement 7Labeling · Standard review	Approved	None posted
Aug 27, 2024	Supplement 9Labeling · Standard review	Approved	None posted
Aug 27, 2024	Supplement 14Labeling · Standard review	Approved	None posted
Aug 27, 2024	Supplement 15Labeling · Standard review	Approved	None posted
Aug 27, 2024	Supplement 17Labeling · Standard review	Approved	None posted
Sep 18, 2018	Supplement 8REMS	Approved	None posted
Aug 17, 2015	Supplement 6Labeling · Standard review	Approved	None posted
Dec 14, 2007	Supplement 5Labeling	Approved	None posted
Feb 2, 2000	Supplement 2Manufacturing	Approved	None posted
Aug 25, 1998	Supplement 1Labeling	Approved	None posted
Mar 25, 1998	Original application	Approved	Review

Identifiers

Application: ANDA 75082
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