Morphine Sulfate

NDA 22195, held by Hikma. Morphine Sulfate.

As of Nov 14, 2026, NDA 22195 (Morphine Sulfate), held by Hikma, was first approved by FDA on Mar 17, 2008, with 18 approved supplements and 0 published complete response letters.

First approved: Mar 17, 2008
Review: Standard
Supplements approved: 18
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Morphine Sulfate Oral Solution 2 mg/mL and 4 mg/mL is indicated for the management of: adults with acute and chronic pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. pediatric patients 2 years of age and older with acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Morphine Sulfate Oral Solution 20 mg/mL is indicated for the relief of acute and chronic pain in opioid-tolerant adult patients.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 19 submissions below


Jun 2, 2021	Supplement 10Efficacy (new indication or use) · Standard review	Approved	Letter Label
Jan 25, 2010	Supplement 2Efficacy (new indication or use) · Priority review	Approved	Letter Label
Mar 17, 2008	Original applicationTYPE 7 · Standard review	Approved	REMS Review Summary Review Label

Products

3 strengths and forms


Morphine Sulfate10MG/5ML · solution;oral	Morphine Sulfate	RxReference drug
Morphine Sulfate20MG/5ML · solution;oral	Morphine Sulfate	RxReference drug
Morphine Sulfate100MG/5ML · solution;oral	Morphine Sulfate	RxReference drug

All 19 submissions, including labeling and manufacturing supplements


Jun 18, 2026	Supplement 25REMS	Approved	Letter
Dec 22, 2025	Supplement 24Labeling · Standard review	Approved	Label Letter
Oct 31, 2024	Supplement 23REMS	Approved	Letter
Dec 15, 2023	Supplement 21Labeling · Standard review	Approved	Letter Label Medication Guide
Jul 22, 2021	Supplement 20Labeling · Standard review	Approved	Letter Label
Jun 2, 2021	Supplement 10Efficacy (new indication or use) · Standard review	Approved	Letter Label
Mar 4, 2021	Supplement 19Labeling · Standard review	Approved	Label Letter
Oct 7, 2019	Supplement 18Labeling · Standard review	Approved	Letter Label
Sep 18, 2018	Supplement 16Labeling · Standard review	Approved	Label Letter
Sep 18, 2018	Supplement 14REMS	Approved	Label Letter
Dec 16, 2016	Supplement 11Labeling · Standard review	Approved	Label Letter
Apr 21, 2015	Supplement 7Manufacturing · Standard review	Approved	Label Letter
Apr 18, 2014	Supplement 8Manufacturing · Standard review	Approved	None posted
Jan 9, 2014	Supplement 9Labeling · Standard review	Approved	Letter
Jan 23, 2012	Supplement 6Labeling · Standard review	Approved	Letter Label
Oct 18, 2011	Supplement 5Labeling · Standard review	Approved	Letter
Jun 10, 2011	Supplement 4Labeling	Approved	None posted
Jan 25, 2010	Supplement 2Efficacy (new indication or use) · Priority review	Approved	Letter Label
Mar 17, 2008	Original applicationTYPE 7 · Standard review	Approved	REMS Review Summary Review Label

Identifiers

Application: NDA 22195
Drugs@FDA: Overview at FDA
Company: Hikma

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