Morphine Sulfate

Manages pain severe enough to require an opioid analgesic. NDA 204223, held by Fresenius Kabi USA. Morphine Sulfate.

As of Nov 13, 2026, NDA 204223 (Morphine Sulfate), held by Fresenius Kabi USA, was first approved by FDA on Oct 30, 2013, with 9 approved supplements and 0 published complete response letters.

First approved: Oct 30, 2013
Review: Standard
Supplements approved: 9
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Morphine Sulfate Injection is an opioid agonist indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. 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 Injection, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. ( 1, 5.1 )

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 10 submissions below

Date	Submission	Status	Documents
Oct 30, 2013	Original applicationNew formulation or manufacturer · Standard review	Approved	Review Summary Review Letter Label

Products

6 strengths and forms


Morphine Sulfate2MG/ML (2MG/ML) · solution;intramuscular, intravenous	Morphine Sulfate	RxReference drug
Morphine Sulfate4MG/ML (4MG/ML) · solution;intramuscular, intravenous	Morphine Sulfate	RxReference drug
Morphine Sulfate5MG/ML (5MG/ML) · solution;intramuscular, intravenous	Morphine Sulfate	DiscontinuedReference drug
Morphine Sulfate8MG/ML (8MG/ML) · solution;intramuscular, intravenous	Morphine Sulfate	DiscontinuedReference drug
Morphine Sulfate10MG/ML (10MG/ML) · solution;intramuscular, intravenous	Morphine Sulfate	RxReference drug
Morphine Sulfate1MG/0.5ML (1MG/0.5ML) · solution;intramuscular, intravenous	Morphine Sulfate	DiscontinuedReference drug

All 10 submissions, including labeling and manufacturing supplements


May 29, 2026	Supplement 29Labeling · Standard review	Approved	Label
Dec 22, 2025	Supplement 28Labeling · Standard review	Approved	Label Letter
Dec 15, 2023	Supplement 25Labeling · Standard review	Approved	Letter Label
Oct 7, 2019	Supplement 15Labeling · Standard review	Approved	Letter Label
Jan 27, 2017	Supplement 7Labeling · Standard review	Approved	None posted
Dec 16, 2016	Supplement 6Labeling · Standard review	Approved	Letter Label
Mar 3, 2015	Supplement 4Manufacturing · Standard review	Approved	None posted
Nov 16, 2014	Supplement 3Manufacturing · Standard review	Approved	None posted
Jun 23, 2014	Supplement 1Manufacturing · Standard review	Approved	None posted
Oct 30, 2013	Original applicationNew formulation or manufacturer · Standard review	Approved	Review Summary Review Letter Label

Identifiers

Application: NDA 204223
Drugs@FDA: Overview at FDA
Company: Fresenius Kabi USA

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