Morphine Sulfate

Manages pain severe enough to require an opioid analgesic. NDA 202515, held by Hospira Inc. Morphine Sulfate.

As of Nov 14, 2026, NDA 202515 (Morphine Sulfate), held by Hospira Inc, was first approved by FDA on Nov 14, 2011, with 8 approved supplements and 0 published complete response letters.

First approved: Nov 14, 2011
Review: Standard
Supplements approved: 8
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Morphine Sulfate Injection is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 9 submissions below


Apr 29, 2021	Supplement 25Efficacy (new indication or use) · Standard review	Approved	Label Letter
Nov 14, 2011	Original applicationTYPE 7 · Standard review	Approved	Review Summary Review Letter Label

Products

6 strengths and forms


Morphine Sulfate2MG/ML · injectable;injection	Morphine Sulfate	RxReference drug
Morphine Sulfate4MG/ML · injectable;injection	Morphine Sulfate	RxReference drug
Morphine Sulfate8MG/ML · injectable;injection	Morphine Sulfate	RxReference drug
Morphine Sulfate10MG/ML · injectable;injection	Morphine Sulfate	RxReference drug
Morphine Sulfate15MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · injectable;injection	Morphine Sulfate	DiscontinuedReference drug
Morphine Sulfate50MG/ML · injectable;injection	Morphine Sulfate	RxReference drug

All 9 submissions, including labeling and manufacturing supplements


Dec 22, 2025	Supplement 46Labeling · Standard review	Approved	Label Letter
Dec 15, 2023	Supplement 37Labeling · Standard review	Approved	Letter Label
Apr 28, 2022	Supplement 33Labeling · Standard review	Approved	Label Letter
Apr 29, 2021	Supplement 25Efficacy (new indication or use) · Standard review	Approved	Label Letter
Aug 17, 2020	Supplement 7Manufacturing	Approved	Label Letter
Oct 7, 2019	Supplement 17Labeling · Standard review	Approved	Letter Label
Dec 16, 2016	Supplement 6Labeling · Standard review	Approved	Letter Label
Aug 14, 2013	Supplement 3Manufacturing · Standard review	Approved	None posted
Nov 14, 2011	Original applicationTYPE 7 · Standard review	Approved	Review Summary Review Letter Label

Identifiers

Application: NDA 202515
Drugs@FDA: Overview at FDA
Company: Hospira

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