Methadose

Treats opioid addiction (heroin or other morphine-like drugs). NDA 17116, held by Specgx LLC. Methadone Hydrochloride.

As of Nov 13, 2026, NDA 17116 (Methadose), held by Specgx LLC, was first approved by FDA on Mar 14, 1973, with 23 approved supplements and 0 published complete response letters.

First approved: Mar 14, 1973
Review: Standard
Supplements approved: 23
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

METHADOSE 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. METHADOSE is an opioid agonist indicated for the: Detoxification treatment of opioid addiction (heroin or other morphine-like drugs).

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 24 submissions below

Date	Submission	Status	Documents
Mar 14, 1973	Original applicationNew dosage form · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Methadose10MG/ML · concentrate;oral	Methadone Hydrochloride	RxReference drug

All 24 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Dec 22, 2025	Supplement 48Labeling · Standard review	Approved	Label Letter
Dec 15, 2023	Supplement 45Labeling · Standard review	Approved	Letter Label
Sep 13, 2021	Supplement 43Labeling · Standard review	Approved	Label Letter
Jun 2, 2021	Supplement 41Labeling · Standard review	Approved	Letter Label
Oct 7, 2019	Supplement 38Labeling · Standard review	Approved	Label Letter
Feb 1, 2018	Supplement 32Labeling · Standard review	Approved	Letter Label
Dec 16, 2016	Supplement 29Labeling · Standard review	Approved	Letter Label
Sep 22, 2014	Supplement 27Manufacturing · Standard review	Approved	None posted
Jun 2, 2014	Supplement 26Manufacturing · Standard review	Approved	None posted
Feb 4, 2008	Supplement 21Labeling · Standard review	Approved	Label Letter
Aug 3, 2005	Supplement 19Manufacturing · Standard review	Approved	Letter
Aug 3, 2005	Supplement 18Manufacturing · Standard review	Approved	Letter
May 26, 2005	Supplement 16Labeling · Standard review	Approved	Letter Label
May 26, 2005	Supplement 15Labeling · Standard review	Approved	Letter Label
Mar 27, 2002	Supplement 14Manufacturing · Standard review	Approved	Letter
Apr 3, 2000	Supplement 13Manufacturing · Standard review	Approved	None posted
Apr 20, 1993	Supplement 12Labeling	Approved	None posted
Sep 7, 1982	Supplement 10Manufacturing · Standard review	Approved	None posted
Nov 25, 1981	Supplement 9Manufacturing · Standard review	Approved	None posted
Feb 6, 1980	Supplement 8Manufacturing · Standard review	Approved	None posted
Feb 6, 1980	Supplement 7Labeling	Approved	None posted
Feb 11, 1977	Supplement 2Labeling	Approved	None posted
Aug 6, 1976	Supplement 1Manufacturing · Standard review	Approved	None posted
Mar 14, 1973	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 17116
Drugs@FDA: Overview at FDA
Company: SpecGx

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