Morphine Sulfate

Manages severe and persistent pain. ANDA 200411, held by Impax Labs Inc. Morphine Sulfate.

As of Nov 15, 2026, ANDA 200411 (Morphine Sulfate), held by Impax Labs Inc, was first approved by FDA on Apr 12, 2016, with 16 approved supplements and 0 published complete response letters.

First approved: Apr 12, 2016
Supplements approved: 16
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 17 submissions below

Date	Submission	Status	Documents
Apr 12, 2016	Original application	Approved	Other

Products

7 strengths and forms


Morphine Sulfate20MG · capsule, extended release;oral	Morphine Sulfate	Discontinued
Morphine Sulfate30MG · capsule, extended release;oral	Morphine Sulfate	Discontinued
Morphine Sulfate50MG · capsule, extended release;oral	Morphine Sulfate	Discontinued
Morphine Sulfate60MG · capsule, extended release;oral	Morphine Sulfate	Discontinued
Morphine Sulfate80MG · capsule, extended release;oral	Morphine Sulfate	Discontinued
Morphine Sulfate100MG · capsule, extended release;oral	Morphine Sulfate	Discontinued
Morphine Sulfate40MG · capsule, extended release;oral	Morphine Sulfate	Discontinued

All 17 submissions, including labeling and manufacturing supplements


Jun 18, 2026	Supplement 28REMS	Approved	None posted
Dec 22, 2025	Supplement 27Labeling · 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 22Labeling · Standard review	Approved	None posted
Dec 15, 2023	Supplement 23Labeling · Standard review	Approved	None posted
Dec 6, 2023	Supplement 14Labeling · Standard review	Approved	None posted
Dec 6, 2023	Supplement 18Labeling · Standard review	Approved	None posted
Dec 6, 2023	Supplement 20Labeling · Standard review	Approved	None posted
Dec 6, 2023	Supplement 21Labeling · Standard review	Approved	None posted
Sep 18, 2018	Supplement 10REMS	Approved	None posted
Jul 19, 2018	Supplement 5Labeling · Standard review	Approved	None posted
May 26, 2017	Supplement 6REMS	Approved	None posted
May 19, 2017	Supplement 4Manufacturing	Approved	None posted
Sep 30, 2016	Supplement 3REMS	Approved	None posted
Apr 20, 2016	Supplement 1REMS	Approved	None posted
Apr 12, 2016	Original application	Approved	Other

Identifiers

Application: ANDA 200411
Drugs@FDA: Overview at FDA
Company: Impax 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