Morphine Sulfate

Manages severe and persistent pain. ANDA 79040, held by Actavis Elizabeth. Morphine Sulfate.

As of Nov 15, 2026, ANDA 79040 (Morphine Sulfate), held by Actavis Elizabeth, was first approved by FDA on Jan 16, 2013, with 22 approved supplements and 0 published complete response letters.

First approved: Jan 16, 2013
Supplements approved: 22
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Morphine sulfate extended-release capsules 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 capsules 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 23 submissions below

Date	Submission	Status	Documents
Jan 16, 2013	Original application	Approved	Other Review

Products

6 strengths and forms


Morphine Sulfate30MG · capsule, extended release;oral	Morphine Sulfate	Rx
Morphine Sulfate45MG · capsule, extended release;oral	Morphine Sulfate	Rx
Morphine Sulfate60MG · capsule, extended release;oral	Morphine Sulfate	Rx
Morphine Sulfate75MG · capsule, extended release;oral	Morphine Sulfate	Rx
Morphine Sulfate90MG · capsule, extended release;oral	Morphine Sulfate	Rx
Morphine Sulfate120MG · capsule, extended release;oral	Morphine Sulfate	Rx

All 23 submissions, including labeling and manufacturing supplements


Jun 18, 2026	Supplement 39REMS	Approved	None posted
Dec 22, 2025	Supplement 37Labeling · Standard review	Approved	None posted
Oct 1, 2025	Supplement 29Labeling · Standard review	Approved	None posted
Apr 11, 2025	Supplement 32Manufacturing	Approved	None posted
Oct 31, 2024	Supplement 30REMS	Approved	None posted
Dec 15, 2023	Supplement 27Labeling · Standard review	Approved	None posted
Dec 15, 2023	Supplement 26Labeling · Standard review	Approved	None posted
Dec 4, 2023	Supplement 24Labeling · Standard review	Approved	None posted
Mar 11, 2021	Supplement 15Labeling · Standard review	Approved	None posted
Mar 11, 2021	Supplement 13Labeling · Standard review	Approved	None posted
Mar 4, 2021	Supplement 23Labeling · Standard review	Approved	None posted
Feb 2, 2021	Supplement 20Labeling · Standard review	Approved	None posted
Oct 11, 2019	Supplement 21Labeling · Standard review	Approved	None posted
Sep 18, 2018	Supplement 18REMS	Approved	None posted
May 26, 2017	Supplement 17REMS	Approved	None posted
Sep 30, 2016	Supplement 14REMS	Approved	None posted
Apr 20, 2016	Supplement 11REMS	Approved	None posted
Jun 26, 2015	Supplement 10REMS	Approved	None posted
Aug 19, 2014	Supplement 7REMS	Approved	None posted
Jul 3, 2014	Supplement 5Labeling · Standard review	Approved	None posted
Jul 2, 2014	Supplement 4Manufacturing	Approved	None posted
Apr 15, 2013	Supplement 3REMS	Approved	None posted
Jan 16, 2013	Original application	Approved	Other Review

Identifiers

Application: ANDA 79040
Drugs@FDA: Overview at FDA
Company: Actavis Elizabeth

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