Morphine Sulfate

Manages severe and persistent pain. ANDA 202104, held by Upsher Smith Labs. Morphine Sulfate.

As of Nov 15, 2026, ANDA 202104 (Morphine Sulfate), held by Upsher Smith Labs, was first approved by FDA on Jun 3, 2013, with 15 approved supplements and 0 published complete response letters.

First approved: Jun 3, 2013
Supplements approved: 15
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 extended treatment period with a daily opioid analgesic and for which alternative treatment options are inadequate.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 16 submissions below

Date	Submission	Status	Documents
Jun 3, 2013	Original application	Approved	Other

Products

7 strengths and forms


Morphine Sulfate10MG · capsule, extended release;oral	Morphine Sulfate	Rx
Morphine Sulfate20MG · capsule, extended release;oral	Morphine Sulfate	Rx
Morphine Sulfate30MG · capsule, extended release;oral	Morphine Sulfate	Rx
Morphine Sulfate50MG · capsule, extended release;oral	Morphine Sulfate	Rx
Morphine Sulfate60MG · capsule, extended release;oral	Morphine Sulfate	Rx
Morphine Sulfate80MG · capsule, extended release;oral	Morphine Sulfate	Rx
Morphine Sulfate100MG · capsule, extended release;oral	Morphine Sulfate	Rx

All 16 submissions, including labeling and manufacturing supplements


Jun 18, 2026	Supplement 29REMS	Approved	None posted
Dec 22, 2025	Supplement 26Labeling · Standard review	Approved	None posted
Oct 9, 2025	Supplement 24Labeling · Standard review	Approved	None posted
Oct 31, 2024	Supplement 25REMS	Approved	None posted
Dec 15, 2023	Supplement 23Labeling · Standard review	Approved	None posted
Dec 15, 2021	Supplement 13Labeling · Standard review	Approved	None posted
Dec 15, 2021	Supplement 14Labeling · Standard review	Approved	None posted
Dec 15, 2021	Supplement 18Labeling · Standard review	Approved	None posted
Sep 18, 2018	Supplement 11REMS	Approved	None posted
May 26, 2017	Supplement 9REMS	Approved	None posted
Sep 30, 2016	Supplement 7REMS	Approved	None posted
Apr 20, 2016	Supplement 6REMS	Approved	None posted
Jun 26, 2015	Supplement 5REMS	Approved	None posted
Aug 19, 2014	Supplement 4REMS	Approved	None posted
Jul 15, 2014	Supplement 2Labeling · Standard review	Approved	None posted
Jun 3, 2013	Original application	Approved	Other

Identifiers

Application: ANDA 202104
Drugs@FDA: Overview at FDA
Company: Upsher-Smith Laboratories

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