Morphine Sulfate

ANDA 75656, held by Watson Labs. Morphine Sulfate.

As of Nov 15, 2026, ANDA 75656 (Morphine Sulfate), held by Watson Labs, was first approved by FDA on Jan 30, 2001, with 5 approved supplements and 0 published complete response letters.

First approved: Jan 30, 2001
Supplements approved: 5
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 6 submissions below

Date	Submission	Status	Documents
Jan 30, 2001	Original application	Approved	Review Letter

Products

1 strengths and forms

Product	Active ingredient	Marketing
Morphine Sulfate100MG · tablet, extended release;oral	Morphine Sulfate	Discontinued

All 6 submissions, including labeling and manufacturing supplements


Jan 15, 2015	Supplement 7Labeling · Standard review	Approved	None posted
Oct 10, 2003	Supplement 4Labeling	Approved	None posted
Jul 15, 2002	Supplement 3Manufacturing	Approved	None posted
May 8, 2002	Supplement 2Manufacturing	Approved	None posted
Mar 27, 2002	Supplement 1Manufacturing	Approved	None posted
Jan 30, 2001	Original application	Approved	Review Letter

Identifiers

Application: ANDA 75656
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