Methadone Hydrochloride Intensol

Manages pain severe enough to require daily, around-the-clock, long-term opioid treatment. ANDA 89897, held by Hikma. Methadone Hydrochloride.

As of Nov 15, 2026, ANDA 89897 (Methadone Hydrochloride Intensol), held by Hikma, was first approved by FDA on Sep 6, 1988, with 38 approved supplements and 0 published complete response letters.

First approved: Sep 6, 1988
Supplements approved: 38
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Methadone Hydrochloride Oral Concentrate ( Intensol ) contains methadone, an opioid agonist indicated for the:

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 o 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 Intensol 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 39 submissions below

Date	Submission	Status	Documents
Sep 6, 1988	Original application	Approved	Other

Products

1 strengths and forms

Product	Active ingredient	Marketing
Methadone Hydrochloride Intensol10MG/ML · concentrate;oral	Methadone Hydrochloride	Rx

All 39 submissions, including labeling and manufacturing supplements


Jun 18, 2026	Supplement 50REMS	Approved	None posted
Oct 31, 2024	Supplement 48REMS	Approved	None posted
May 31, 2024	Supplement 46Labeling · Standard review	Approved	None posted
May 31, 2024	Supplement 45Labeling · Standard review	Approved	None posted
May 31, 2024	Supplement 42Labeling · Standard review	Approved	None posted
May 31, 2024	Supplement 40Labeling · Standard review	Approved	None posted
May 31, 2024	Supplement 33Labeling · Standard review	Approved	None posted
Apr 14, 2021	Supplement 44Manufacturing	Approved	None posted
Sep 18, 2018	Supplement 39REMS	Approved	None posted
Jun 27, 2017	Supplement 36Labeling · Standard review	Approved	None posted
May 26, 2017	Supplement 38REMS	Approved	None posted
Sep 30, 2016	Supplement 35REMS	Approved	None posted
Apr 20, 2016	Supplement 34REMS	Approved	None posted
Jun 26, 2015	Supplement 32REMS	Approved	None posted
Aug 19, 2014	Supplement 31REMS	Approved	None posted
Apr 16, 2014	Supplement 28Labeling · Standard review	Approved	Label
Apr 15, 2013	Supplement 27REMS	Approved	None posted
Jul 9, 2012	Supplement 26REMS	Approved	None posted
Jul 9, 2012	Supplement 25Labeling · Standard review	Approved	None posted
Aug 27, 2008	Supplement 22Labeling	Approved	None posted
Jan 14, 2008	Supplement 21Labeling	Approved	None posted
Jan 14, 2008	Supplement 20Labeling	Approved	None posted
Dec 12, 2007	Supplement 19Labeling	Approved	None posted
May 9, 2007	Supplement 18Labeling	Approved	None posted
Mar 21, 2001	Supplement 14Manufacturing	Approved	None posted
Sep 5, 2000	Supplement 13Manufacturing	Approved	None posted
Feb 1, 2000	Supplement 12Manufacturing	Approved	None posted
Apr 23, 1999	Supplement 5Manufacturing	Approved	None posted
Apr 23, 1999	Supplement 4Manufacturing	Approved	None posted
Mar 12, 1999	Supplement 11Manufacturing	Approved	None posted
Mar 12, 1999	Supplement 10Manufacturing	Approved	None posted
Jan 29, 1997	Supplement 8Manufacturing	Approved	None posted
Jan 29, 1997	Supplement 7Labeling	Approved	None posted
Jan 29, 1997	Supplement 6Manufacturing	Approved	None posted
Aug 28, 1996	Supplement 9Manufacturing	Approved	None posted
Jun 15, 1993	Supplement 3Manufacturing	Approved	None posted
Jun 15, 1993	Supplement 2Manufacturing	Approved	None posted
Jun 15, 1993	Supplement 1Labeling	Approved	None posted
Sep 6, 1988	Original application	Approved	Other

Identifiers

Application: ANDA 89897
Drugs@FDA: Overview at FDA
Company: Hikma

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