Morphine Sulfate

NDA 19917, held by Icu Medical Inc. Morphine Sulfate.

As of Nov 13, 2026, NDA 19917 (Morphine Sulfate), held by Icu Medical Inc, was first approved by FDA on Oct 30, 1992, with 4 approved supplements and 0 published complete response letters.

First approved: Oct 30, 1992
Review: Standard
Supplements approved: 4
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 5 submissions below

Date	Submission	Status	Documents
Oct 30, 1992	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Morphine Sulfate0.5MG/ML · injectable;injection	Morphine Sulfate	Discontinued

All 5 submissions, including labeling and manufacturing supplements


Oct 7, 2019	Supplement 12Labeling · Standard review	Approved	Letter Label
Dec 16, 2016	Supplement 10Labeling · Standard review	Approved	Label Letter
Dec 16, 2016	Supplement 11Labeling · Standard review	Approved	Label Letter
Jan 19, 1996	Supplement 1Manufacturing · Standard review	Approved	None posted
Oct 30, 1992	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 19917
Drugs@FDA: Overview at FDA
Company: ICU Medical

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