Morphine Sulfate

Manages severe and persistent pain. ANDA 74769, held by Rhodes Pharms. Morphine Sulfate.

As of Nov 15, 2026, ANDA 74769 (Morphine Sulfate), held by Rhodes Pharms, was first approved by FDA on Jul 2, 1998, with 17 approved supplements and 0 published complete response letters.

First approved: Jul 2, 1998
Supplements approved: 17
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.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 18 submissions below

Date	Submission	Status	Documents
Jul 2, 1998	Original application	Approved	Other Review Letter Label

Products

2 strengths and forms


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

All 18 submissions, including labeling and manufacturing supplements


Jun 18, 2026	Supplement 35REMS	Approved	None posted
Sep 18, 2018	Supplement 29REMS	Approved	None posted
May 26, 2017	Supplement 28REMS	Approved	None posted
Sep 30, 2016	Supplement 27REMS	Approved	None posted
Apr 20, 2016	Supplement 24REMS	Approved	None posted
Jun 26, 2015	Supplement 22REMS	Approved	None posted
Aug 19, 2014	Supplement 20REMS	Approved	None posted
Jul 21, 2014	Supplement 19Labeling · Standard review	Approved	None posted
Apr 15, 2013	Supplement 13REMS	Approved	None posted
Sep 28, 2012	Supplement 12Labeling	Approved	None posted
Jul 9, 2012	Supplement 10REMS	Approved	None posted
Jul 11, 2000	Supplement 2Manufacturing	Approved	None posted
Jul 11, 2000	Supplement 3Manufacturing	Approved	None posted
Jul 11, 2000	Supplement 4Manufacturing	Approved	None posted
Jul 11, 2000	Supplement 5Manufacturing	Approved	None posted
Jul 11, 2000	Supplement 6Manufacturing	Approved	None posted
Jul 11, 2000	Supplement 7Manufacturing	Approved	None posted
Jul 2, 1998	Original application	Approved	Other Review Letter Label

Identifiers

Application: ANDA 74769
Drugs@FDA: Overview at FDA
Company: Rhodes Pharmaceuticals

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