Methadone Hydrochloride

Manages pain severe enough to require daily, around-the-clock, long-term opioid treatment. ANDA 90635, held by Thepharmanetwork LLC. Methadone Hydrochloride.

As of Nov 15, 2026, ANDA 90635 (Methadone Hydrochloride), held by Thepharmanetwork LLC, was first approved by FDA on Nov 25, 2009, with 21 approved supplements and 0 published complete response letters.

First approved: Nov 25, 2009
Supplements approved: 21
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Methadone hydrochloride tablets, USP are indicated for the: 1. Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Limitations of Use

Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with long-acting opioids, reserve methadone hydrochloride tablets, USP for use in patients for whom alternative analgesic treatment options (e.g.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 22 submissions below

Date	Submission	Status	Documents
Nov 25, 2009	Original application	Approved	Other

Products

2 strengths and forms


Methadone Hydrochloride10MG · tablet;oral	Methadone Hydrochloride	Rx
Methadone Hydrochloride5MG · tablet;oral	Methadone Hydrochloride	Rx

All 22 submissions, including labeling and manufacturing supplements


Jun 18, 2026	Supplement 38REMS	Approved	None posted
Dec 22, 2025	Supplement 37Labeling · Standard review	Approved	None posted
Oct 31, 2024	Supplement 34REMS	Approved	None posted
Mar 8, 2024	Supplement 32Labeling · Standard review	Approved	None posted
Mar 8, 2024	Supplement 31Labeling · Standard review	Approved	None posted
Dec 4, 2023	Supplement 29Labeling · Standard review	Approved	None posted
Dec 4, 2023	Supplement 25Labeling · Standard review	Approved	None posted
Jul 16, 2019	Supplement 22Labeling · Standard review	Approved	None posted
Jul 16, 2019	Supplement 21Labeling · Standard review	Approved	None posted
Jul 16, 2019	Supplement 19Labeling · Standard review	Approved	None posted
Sep 18, 2018	Supplement 20REMS	Approved	None posted
May 26, 2017	Supplement 16REMS	Approved	None posted
Sep 30, 2016	Supplement 14REMS	Approved	None posted
Apr 20, 2016	Supplement 13REMS	Approved	None posted
Jun 26, 2015	Supplement 10REMS	Approved	None posted
Jun 4, 2015	Supplement 11Labeling · Standard review	Approved	None posted
Aug 19, 2014	Supplement 9REMS	Approved	None posted
Jul 23, 2014	Supplement 7Labeling · Standard review	Approved	None posted
Apr 15, 2013	Supplement 5REMS	Approved	None posted
Jul 9, 2012	Supplement 4Labeling	Approved	None posted
Jul 9, 2012	Supplement 3Labeling	Approved	None posted
Nov 25, 2009	Original application	Approved	Other

Identifiers

Application: ANDA 90635
Drugs@FDA: Overview at FDA
Company: THEPHARMANETWORK LLC

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