Morphine Sulfate

NDA 19916, held by Icu Medical Inc. Morphine Sulfate.

As of Nov 13, 2026, NDA 19916 (Morphine Sulfate), held by Icu Medical Inc, was first approved by FDA on Oct 30, 1992, with 7 approved supplements and 0 published complete response letters.

First approved: Oct 30, 1992
Review: Standard
Supplements approved: 7
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 8 submissions below

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

Products

2 strengths and forms


Morphine Sulfate1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · injectable;injection	Morphine Sulfate	DiscontinuedReference drug
Morphine Sulfate5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · injectable;injection	Morphine Sulfate	DiscontinuedReference drug

All 8 submissions, including labeling and manufacturing supplements


Oct 7, 2019	Supplement 19Labeling · Standard review	Approved	Letter Label
Dec 16, 2016	Supplement 17Labeling · Standard review	Approved	Label Letter
Dec 16, 2016	Supplement 16Labeling · Standard review	Approved	Label Letter
Mar 9, 2016	Supplement 15Manufacturing · Standard review	Approved	None posted
Mar 18, 2008	Supplement 10Manufacturing	Approved	None posted
Oct 27, 2006	Supplement 4Manufacturing	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 19916
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