Methadose

ANDA 40050, held by Specgx LLC. Methadone Hydrochloride.

As of Nov 15, 2026, ANDA 40050 (Methadose), held by Specgx LLC, was first approved by FDA on Apr 15, 1993, with 26 approved supplements and 0 published complete response letters.

First approved: Apr 15, 1993
Supplements approved: 26
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 27 submissions below

Date	Submission	Status	Documents
Apr 15, 1993	Original application	Approved	Other

Products

2 strengths and forms


Methadose5MG · tablet;oral	Methadone Hydrochloride	Discontinued
Methadose10MG · tablet;oral	Methadone Hydrochloride	Discontinued

All 27 submissions, including labeling and manufacturing supplements


Jun 18, 2026	Supplement 35REMS	Approved	None posted
Dec 23, 2025	Supplement 34Labeling · Standard review	Approved	None posted
Jun 24, 2025	Supplement 32Labeling · Standard review	Approved	None posted
Oct 31, 2024	Supplement 33REMS	Approved	None posted
Dec 15, 2023	Supplement 31Labeling · Standard review	Approved	None posted
Dec 15, 2023	Supplement 30Labeling · Standard review	Approved	None posted
Nov 23, 2022	Supplement 29Labeling · Standard review	Approved	None posted
Nov 23, 2022	Supplement 28Labeling · Standard review	Approved	None posted
Nov 23, 2022	Supplement 26Labeling · Standard review	Approved	None posted
Nov 23, 2022	Supplement 25Labeling · Standard review	Approved	None posted
Sep 18, 2018	Supplement 27REMS	Approved	None posted
May 26, 2017	Supplement 24REMS	Approved	None posted
Sep 30, 2016	Supplement 22REMS	Approved	None posted
Apr 20, 2016	Supplement 21REMS	Approved	None posted
Jun 26, 2015	Supplement 19REMS	Approved	None posted
Jun 1, 2015	Supplement 20Labeling · Standard review	Approved	None posted
Aug 19, 2014	Supplement 18REMS	Approved	None posted
Jul 23, 2014	Supplement 16Labeling · Standard review	Approved	None posted
Apr 15, 2013	Supplement 14REMS	Approved	None posted
Jul 9, 2012	Supplement 13Labeling	Approved	None posted
Jul 9, 2012	Supplement 12REMS	Approved	None posted
Jan 10, 2007	Supplement 10Labeling	Approved	None posted
Nov 14, 2000	Supplement 5Manufacturing	Approved	None posted
Mar 2, 1998	Supplement 3Manufacturing	Approved	None posted
Apr 24, 1995	Supplement 2Manufacturing	Approved	None posted
Sep 29, 1994	Supplement 1Manufacturing	Approved	None posted
Apr 15, 1993	Original application	Approved	Other

Identifiers

Application: ANDA 40050
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