Morphine Sulfate

Manages pain severe enough to require daily, around-the-clock, long-term opioid treatment. ANDA 78761, held by Sun Pharm Inds Ltd. Morphine Sulfate.

As of Nov 15, 2026, ANDA 78761 (Morphine Sulfate), held by Sun Pharm Inds Ltd, was first approved by FDA on May 11, 2012, with 11 approved supplements and 0 published complete response letters.

First approved: May 11, 2012
Supplements approved: 11
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 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 extended-release opioid formulations, reserve morphine sulfate extended-release tablets for use in patients for whom alternative treatment options (e.g.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 12 submissions below

Date	Submission	Status	Documents
May 11, 2012	Original application	Approved	Other

Products

5 strengths and forms


Morphine Sulfate15MG · tablet, extended release;oral	Morphine Sulfate	Rx
Morphine Sulfate30MG · tablet, extended release;oral	Morphine Sulfate	Rx
Morphine Sulfate60MG · tablet, extended release;oral	Morphine Sulfate	Rx
Morphine Sulfate100MG · tablet, extended release;oral	Morphine Sulfate	Rx
Morphine Sulfate200MG · tablet, extended release;oral	Morphine Sulfate	Rx

All 12 submissions, including labeling and manufacturing supplements


Jun 18, 2026	Supplement 31REMS	Approved	None posted
Oct 31, 2024	Supplement 24REMS	Approved	None posted
Sep 18, 2018	Supplement 13REMS	Approved	None posted
May 26, 2017	Supplement 11REMS	Approved	None posted
Sep 30, 2016	Supplement 10REMS	Approved	None posted
Apr 20, 2016	Supplement 8REMS	Approved	None posted
Jun 26, 2015	Supplement 7REMS	Approved	None posted
Aug 19, 2014	Supplement 5REMS	Approved	None posted
Jun 23, 2014	Supplement 3Labeling · Standard review	Approved	None posted
Apr 15, 2013	Supplement 2Labeling · Standard review	Approved	None posted
Sep 28, 2012	Supplement 1Labeling · Standard review	Approved	None posted
May 11, 2012	Original application	Approved	Other

Identifiers

Application: ANDA 78761
Drugs@FDA: Overview at FDA
Company: Sun Pharmaceutical Industries

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