Methadone Hydrochloride

Manages severe and persistent pain. ANDA 90065, held by Epic Pharma LLC. Methadone Hydrochloride.

As of Nov 15, 2026, ANDA 90065 (Methadone Hydrochloride), held by Epic Pharma LLC, was first approved by FDA on Aug 18, 2015, with 14 approved supplements and 0 published complete response letters.

First approved: Aug 18, 2015
Supplements approved: 14
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Methadone hydrochloride tablets are indicated for the: 1. Management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids. Limitations of Use

Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy, reserve opioid analgesics, including methadone hydrochloride tablets for use in patients for whom alternative analgesic treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 15 submissions below

Date	Submission	Status	Documents
Aug 18, 2015	Original application	Approved	REMS

Products

2 strengths and forms


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

All 15 submissions, including labeling and manufacturing supplements


Jun 18, 2026	Supplement 18REMS	Approved	None posted
Dec 22, 2025	Supplement 16Labeling · Standard review	Approved	None posted
Dec 22, 2025	Supplement 17Labeling · Standard review	Approved	None posted
Oct 31, 2024	Supplement 15REMS	Approved	None posted
Jan 12, 2024	Supplement 14Labeling · Standard review	Approved	None posted
Dec 8, 2023	Supplement 5Labeling · Standard review	Approved	None posted
Dec 8, 2023	Supplement 8Labeling · Standard review	Approved	None posted
Dec 8, 2023	Supplement 10Labeling · Standard review	Approved	None posted
Dec 8, 2023	Supplement 11Labeling · Standard review	Approved	None posted
Dec 8, 2023	Supplement 13Labeling · Standard review	Approved	None posted
Sep 18, 2018	Supplement 9REMS	Approved	None posted
May 26, 2017	Supplement 6REMS	Approved	None posted
Sep 30, 2016	Supplement 4REMS	Approved	None posted
Apr 20, 2016	Supplement 1REMS	Approved	None posted
Aug 18, 2015	Original application	Approved	REMS

Identifiers

Application: ANDA 90065
Drugs@FDA: Overview at FDA
Company: Epic Pharma

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