Morphine Sulfate

Manages severe and persistent pain. ANDA 76438, held by Specgx LLC. Morphine Sulfate.

As of Nov 15, 2026, ANDA 76438 (Morphine Sulfate), held by Specgx LLC, was first approved by FDA on Jul 3, 2003, with 25 approved supplements and 0 published complete response letters.

First approved: Jul 3, 2003
Supplements approved: 25
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Morphine sulfate extended-release tablets are 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 morphine sulfate extended-release tablets, for use in patients for whom alternative 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 26 submissions below

Date	Submission	Status	Documents
Jul 3, 2003	Original application	Approved	Other

Products

2 strengths and forms


Morphine Sulfate100MG · tablet, extended release;oral	Morphine Sulfate	Rx
Morphine Sulfate200MG · tablet, extended release;oral	Morphine Sulfate	Rx

All 26 submissions, including labeling and manufacturing supplements


Sep 11, 2026	Supplement 45Labeling · Standard review	Approved	None posted
Sep 11, 2026	Supplement 42Labeling · Standard review	Approved	None posted
Sep 11, 2026	Supplement 36Labeling · Standard review	Approved	None posted
Sep 11, 2026	Supplement 30Labeling · Standard review	Approved	None posted
Sep 11, 2026	Supplement 27Labeling · Standard review	Approved	None posted
Sep 11, 2026	Supplement 24Labeling · Standard review	Approved	None posted
Jun 18, 2026	Supplement 44REMS	Approved	None posted
Oct 31, 2024	Supplement 41REMS	Approved	None posted
Sep 18, 2018	Supplement 25REMS	Approved	None posted
May 26, 2017	Supplement 23REMS	Approved	None posted
Nov 3, 2016	Supplement 21Labeling · Standard review	Approved	None posted
Sep 30, 2016	Supplement 22REMS	Approved	None posted
Apr 20, 2016	Supplement 19REMS	Approved	None posted
Jun 26, 2015	Supplement 17REMS	Approved	None posted
May 16, 2015	Supplement 16Labeling · Standard review	Approved	None posted
Aug 19, 2014	Supplement 15REMS	Approved	None posted
Aug 13, 2014	Supplement 9Labeling	Approved	None posted
Jun 25, 2014	Supplement 13Labeling · Standard review	Approved	None posted
Apr 15, 2013	Supplement 12REMS	Approved	None posted
Jul 9, 2012	Supplement 11Labeling	Approved	None posted
Jul 9, 2012	Supplement 10REMS	Approved	None posted
Jul 22, 2009	Supplement 7Labeling	Approved	None posted
Sep 30, 2004	Supplement 5Labeling	Approved	None posted
Mar 19, 2004	Supplement 2Labeling	Approved	None posted
Nov 6, 2003	Supplement 3Labeling	Approved	None posted
Jul 3, 2003	Original application	Approved	Other

Identifiers

Application: ANDA 76438
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