Duramorph Pf, Infumorph

Manages intractable chronic pain severe enough to require an opioid analgesic. NDA 18565, held by Hikma. Morphine Sulfate.

As of Nov 13, 2026, NDA 18565 (Duramorph Pf, Infumorph), held by Hikma, was first approved by FDA on Sep 18, 1984, with 23 approved supplements and 0 published complete response letters.

First approved: Sep 18, 1984
Review: Priority
Supplements approved: 23
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INFUMORPH is for use in continuous microinfusion devices and indicated only for intrathecal or epidural infusion in the management of intractable chronic pain severe enough to require an opioid analgesic and for which less invasive means of controlling pain are inadequate. Limitations of Use Not for single-dose intravenous, intramuscular, or subcutaneous administration due to the risk of overdose. Not for single-dose neuraxial injection because INFUMORPH is too concentrated for accurate delivery of the smaller doses used in this setting.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 24 submissions below

Date	Submission	Status	Documents
Sep 18, 1984	Original applicationNew dosage form · Priority review	Approved	None posted

Products

4 strengths and forms

Product	Active ingredient	Marketing
Duramorph Pf0.5MG/ML · injectable;injection	Morphine Sulfate	RxReference drug
Duramorph Pf1MG/ML · injectable;injection	Morphine Sulfate	RxReference drug
Infumorph10MG/ML · injectable;injection	Morphine Sulfate	RxReference drug
Infumorph25MG/ML · injectable;injection	Morphine Sulfate	RxReference drug

All 24 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Dec 22, 2025	Supplement 36Labeling · Standard review	Approved	Label Letter
Dec 22, 2025	Supplement 35Labeling · Standard review	Approved	Label Letter
Dec 15, 2023	Supplement 31Labeling · Standard review	Approved	Letter Label
Dec 15, 2023	Supplement 30Labeling · Standard review	Approved	Letter Label
Dec 15, 2023	Supplement 28Labeling · Standard review	Approved	Letter Label
Dec 15, 2023	Supplement 27Labeling · Standard review	Approved	Letter Label
Nov 8, 2023	Supplement 29Labeling · Standard review	Approved	Letter Label
Oct 7, 2019	Supplement 24Labeling · Standard review	Approved	Letter Label
Dec 16, 2016	Supplement 22Labeling · Standard review	Approved	Label Letter Label Letter
Jun 6, 2016	Supplement 21Manufacturing · Priority review	Approved	None posted
Oct 1, 2010	Supplement 20Labeling · Standard review	Approved	Label Letter
Jun 6, 2005	Supplement 14Labeling · Standard review	Approved	Letter Label
May 27, 2004	Supplement 12Labeling · Standard review	Approved	Label Letter
Jun 26, 2003	Supplement 10Labeling · Standard review	Approved	Letter
Dec 7, 2001	Supplement 9Labeling · Standard review	Approved	None posted
Jun 14, 1999	Supplement 8Manufacturing · Priority review	Approved	None posted
Apr 17, 1998	Supplement 7Manufacturing · Priority review	Approved	None posted
Feb 12, 1997	Supplement 6Manufacturing · Priority review	Approved	None posted
Apr 28, 1994	Supplement 5Labeling	Approved	None posted
Jul 19, 1991	Supplement 3Labeling	Approved	None posted
Jul 19, 1991	Supplement 2Manufacturing · Priority review	Approved	None posted
May 3, 1989	Supplement 4Labeling	Approved	None posted
Aug 22, 1985	Supplement 1Labeling	Approved	None posted
Sep 18, 1984	Original applicationNew dosage form · Priority review	Approved	None posted

Identifiers

Application: NDA 18565
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