Morphine Sulfate

For acute pain severe enough to require an opioid analgesic. NDA 22207, held by Hikma. Morphine Sulfate.

As of Nov 13, 2026, NDA 22207 (Morphine Sulfate), held by Hikma, was first approved by FDA on Mar 17, 2008, with 12 approved supplements and 0 published complete response letters.

First approved: Mar 17, 2008
Review: Standard
Supplements approved: 12
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Morphine Sulfate Tablets are indicated for the management of:

adult and pediatric patients weighing at least 50 kg and above with acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
adults with chronic 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 13 submissions below


Jun 2, 2021	Supplement 5Efficacy (new indication or use) · Standard review	Approved	Label Letter
Mar 17, 2008	Original applicationTYPE 7 · Standard review	Approved	REMS Summary Review Review Label

Products

2 strengths and forms


Morphine Sulfate15MG · tablet;oral	Morphine Sulfate	RxReference drug
Morphine Sulfate30MG · tablet;oral	Morphine Sulfate	RxReference drug

All 13 submissions, including labeling and manufacturing supplements


Jun 18, 2026	Supplement 16REMS	Approved	Letter
Dec 22, 2025	Supplement 14Labeling · Standard review	Approved	Label Letter
Oct 31, 2024	Supplement 13REMS	Approved	Letter
Dec 15, 2023	Supplement 11Labeling · Standard review	Approved	Letter Label Medication Guide
Jun 2, 2021	Supplement 5Efficacy (new indication or use) · Standard review	Approved	Label Letter
Mar 4, 2021	Supplement 10Labeling · Standard review	Approved	Label Letter
Oct 7, 2019	Supplement 9Labeling · Standard review	Approved	Letter Label
Sep 18, 2018	Supplement 7REMS	Approved	Letter Label
Sep 18, 2018	Supplement 8Labeling · Standard review	Approved	Letter Label
Dec 16, 2016	Supplement 6Labeling · Standard review	Approved	Label Letter
Jan 23, 2012	Supplement 4Labeling	Approved	Letter Label
Apr 15, 2010	Supplement 2Labeling	Approved	Letter
Mar 17, 2008	Original applicationTYPE 7 · Standard review	Approved	REMS Summary Review Review Label

Identifiers

Application: NDA 22207
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