Morphine Sulfate

ANDA 71849, held by Hospira. Morphine Sulfate.

As of Nov 15, 2026, ANDA 71849 (Morphine Sulfate), held by Hospira, was first approved by FDA on May 11, 1988, with 6 approved supplements and 0 published complete response letters.

First approved: May 11, 1988
Supplements approved: 6
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 7 submissions below

Date	Submission	Status	Documents
May 11, 1988	Original application	Approved	None posted

Products

1 strengths and forms

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

All 7 submissions, including labeling and manufacturing supplements


Feb 10, 2020	Supplement 13Labeling · Standard review	Approved	None posted
Oct 3, 1996	Supplement 7Manufacturing	Approved	None posted
Nov 26, 1993	Supplement 5Manufacturing	Approved	None posted
Jun 4, 1992	Supplement 4Manufacturing	Approved	None posted
Feb 11, 1991	Supplement 3Manufacturing	Approved	None posted
Apr 27, 1990	Supplement 2Manufacturing	Approved	None posted
May 11, 1988	Original application	Approved	None posted

Identifiers

Application: ANDA 71849
Drugs@FDA: Overview at FDA
Company: Hospira

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