Morphine Sulfate

Manages pain severe enough to require use of an opioid analgesic. ANDA 73510, held by Hospira. Morphine Sulfate.

As of Nov 15, 2026, ANDA 73510 (Morphine Sulfate), held by Hospira, was first approved by FDA on Sep 30, 1992, with 10 approved supplements and 0 published complete response letters.

First approved: Sep 30, 1992
Supplements approved: 10
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Preservative-free morphine sulfate injection is indicated for:

the management of pain severe enough to require use of an opioid analgesic by intravenous administration, and for which alternative treatments are not expected to be adequate.
the epidural or intrathecal management of pain without attendant loss of motor, sensory, or sympathetic function. Preservative-free morphine sulfate injection is an opioid agonist, indicated for: 1. the management of pain severe enough to require use of an opioid analgesic by intravenous administration and for which alternative treatments are not expected to be adequate. 2.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 11 submissions below

Date	Submission	Status	Documents
Sep 30, 1992	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Morphine Sulfate1MG/ML · injectable;injection	Morphine Sulfate	Rx

All 11 submissions, including labeling and manufacturing supplements


Feb 10, 2020	Supplement 20Labeling · Standard review	Approved	None posted
Oct 25, 2002	Supplement 10Manufacturing	Approved	None posted
Mar 22, 2001	Supplement 8Manufacturing	Approved	None posted
Mar 22, 2001	Supplement 9Manufacturing	Approved	None posted
Jan 7, 2000	Supplement 5Manufacturing	Approved	None posted
Jan 7, 2000	Supplement 6Labeling	Approved	None posted
Jul 22, 1999	Supplement 7Manufacturing	Approved	None posted
Oct 22, 1996	Supplement 3Manufacturing	Approved	None posted
Oct 3, 1996	Supplement 4Manufacturing	Approved	None posted
Nov 9, 1995	Supplement 1Manufacturing	Approved	None posted
Sep 30, 1992	Original application	Approved	None posted

Identifiers

Application: ANDA 73510
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