Methadone Hydrochloride

NDA 6383, held by Mallinckrodt Inc. Methadone Hydrochloride.

As of Nov 13, 2026, NDA 6383 (Methadone Hydrochloride), held by Mallinckrodt Inc, was first approved by FDA on Dec 15, 1947, with 8 approved supplements and 0 published complete response letters.

First approved: Dec 15, 1947
Supplements approved: 8
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 9 submissions below

Date	Submission	Status	Documents
Dec 15, 1947	Original application	Approved	None posted

Products

3 strengths and forms


Methadone Hydrochloride50GM/BOT · powder;for rx compounding	Methadone Hydrochloride	Discontinued
Methadone Hydrochloride100GM/BOT · powder;for rx compounding	Methadone Hydrochloride	Discontinued
Methadone Hydrochloride500GM/BOT · powder;for rx compounding	Methadone Hydrochloride	Discontinued

All 9 submissions, including labeling and manufacturing supplements


Feb 1, 2018	Supplement 18Labeling · Standard review	Approved	Letter Label
Dec 16, 2016	Supplement 17Labeling · Standard review	Approved	Label Letter
Jun 5, 2015	Supplement 16Manufacturing	Approved	None posted
Sep 22, 2014	Supplement 15Manufacturing	Approved	None posted
Jun 4, 1997	Supplement 10Manufacturing	Approved	None posted
Jun 2, 1993	Supplement 9Manufacturing	Approved	None posted
Feb 1, 1980	Supplement 6Manufacturing	Approved	None posted
Jun 10, 1977	Supplement 5Labeling	Approved	None posted
Dec 15, 1947	Original application	Approved	None posted

Identifiers

Application: NDA 6383
Drugs@FDA: Overview at FDA
Company: Mallinckrodt

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