Ms Contin

Manages severe and persistent pain. NDA 19516, held by Knoa Pharma. Morphine Sulfate.

As of Nov 13, 2026, NDA 19516 (Ms Contin), held by Knoa Pharma, was first approved by FDA on May 29, 1987, with 40 approved supplements and 0 published complete response letters.

First approved: May 29, 1987
Review: Priority
Supplements approved: 40
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

MS CONTIN is indicated for the 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 MS CONTIN, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. MS CONTIN is not indicated as an as-needed (prn) analgesic.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 41 submissions below

Date	Submission	Status	Documents
May 29, 1987	Original applicationNew dosage form · Priority review	Approved	Other

Products

5 strengths and forms


Ms Contin30MG · tablet, extended release;oral	Morphine Sulfate	RxReference drug
Ms Contin60MG · tablet, extended release;oral	Morphine Sulfate	RxReference drug
Ms Contin15MG · tablet, extended release;oral	Morphine Sulfate	RxReference drug
Ms Contin100MG · tablet, extended release;oral	Morphine Sulfate	DiscontinuedReference drug
Ms Contin200MG · tablet, extended release;oral	Morphine Sulfate	DiscontinuedReference drug

All 41 submissions, including labeling and manufacturing supplements


Jun 18, 2026	Supplement 63REMS	Approved	Letter
Dec 22, 2025	Supplement 62Labeling · Standard review	Approved	Label Medication Guide Letter
Oct 31, 2024	Supplement 60REMS	Approved	Letter
Dec 15, 2023	Supplement 58Labeling · Standard review	Approved	Letter Label
Mar 4, 2021	Supplement 57Labeling · Standard review	Approved	Label Letter
Oct 7, 2019	Supplement 55Labeling · Standard review	Approved	Label Letter
Sep 18, 2018	Supplement 54Labeling · Standard review	Approved	Label Letter
Sep 18, 2018	Supplement 53REMS	Approved	Label Letter
May 26, 2017	Supplement 52REMS	Approved	Letter
Dec 16, 2016	Supplement 49Labeling · Standard review	Approved	Label Letter
Sep 30, 2016	Supplement 50REMS	Approved	Letter
Apr 20, 2016	Supplement 47REMS	Approved	Letter
Jun 26, 2015	Supplement 46REMS	Approved	Letter
Oct 22, 2014	Supplement 43Labeling · Standard review	Approved	Letter Label
Aug 19, 2014	Supplement 44REMS	Approved	Letter
Jun 2, 2014	Supplement 40Manufacturing · Priority review	Approved	None posted
Apr 16, 2014	Supplement 42Labeling	Approved	Letter Label
Apr 15, 2013	Supplement 38REMS	Approved	Letter
Jul 9, 2012	Supplement 37Labeling · Standard review	Approved	Label Letter
Jul 9, 2012	Supplement 36REMS	Approved	Label Letter
May 11, 2010	Supplement 34Labeling	Approved	Label Letter
May 11, 2007	Supplement 30Labeling · Standard review	Approved	Letter
Aug 6, 2003	Supplement 21Labeling · Standard review	Approved	Letter
Feb 21, 2003	Supplement 19Manufacturing · Priority review	Approved	Letter
Dec 18, 2001	Supplement 16Labeling · Standard review	Approved	None posted
Feb 12, 2001	Supplement 15Labeling · Standard review	Approved	None posted
Jun 27, 2000	Supplement 13Manufacturing · Priority review	Approved	None posted
May 12, 2000	Supplement 8Manufacturing · Priority review	Approved	None posted
May 2, 2000	Supplement 9Manufacturing · Priority review	Approved	None posted
May 2, 2000	Supplement 10Manufacturing · Priority review	Approved	None posted
May 2, 2000	Supplement 11Manufacturing · Priority review	Approved	None posted
May 2, 2000	Supplement 12Manufacturing · Priority review	Approved	None posted
May 2, 2000	Supplement 14Manufacturing · Priority review	Approved	None posted
Apr 29, 1997	Supplement 7Manufacturing · Priority review	Approved	None posted
Nov 8, 1993	Supplement 4Manufacturing · Priority review	Approved	None posted
Apr 12, 1990	Supplement 6Manufacturing · Priority review	Approved	None posted
Jan 16, 1990	Supplement 3Manufacturing · Priority review	Approved	None posted
Sep 12, 1989	Supplement 2Manufacturing · Priority review	Approved	None posted
May 2, 1988	Supplement 5Manufacturing · Priority review	Approved	None posted
Apr 8, 1988	Supplement 1Manufacturing · Priority review	Approved	None posted
May 29, 1987	Original applicationNew dosage form · Priority review	Approved	Other

Identifiers

Application: NDA 19516
Drugs@FDA: Overview at FDA
Company: KNOA 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