Morphine Sulfate

ANDA 73376, held by Watson Labs. Morphine Sulfate.

As of Nov 15, 2026, ANDA 73376 (Morphine Sulfate), held by Watson Labs, was first approved by FDA on Sep 30, 1991, with 4 approved supplements and 0 published complete response letters.

First approved: Sep 30, 1991
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
Sep 30, 1991	Original application	Approved	None posted

Products

1 strengths and forms

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

All 5 submissions, including labeling and manufacturing supplements


Mar 12, 1999	Supplement 3Manufacturing	Approved	None posted
Feb 19, 1999	Supplement 4Manufacturing	Approved	None posted
Feb 2, 1999	Supplement 2Manufacturing	Approved	None posted
Mar 19, 1997	Supplement 1Manufacturing	Approved	None posted
Sep 30, 1991	Original application	Approved	None posted

Identifiers

Application: ANDA 73376
Drugs@FDA: Overview at FDA
Company: Watson Laboratories

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