Morphine Sulfate

ANDA 76733, held by Nesher Pharms. Morphine Sulfate.

As of Nov 15, 2026, ANDA 76733 (Morphine Sulfate), held by Nesher Pharms, was first approved by FDA on May 19, 2004, with 11 approved supplements and 0 published complete response letters.

First approved: May 19, 2004
Supplements approved: 11
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 12 submissions below

Date	Submission	Status	Documents
May 19, 2004	Original application	Approved	Other

Products

1 strengths and forms

Product	Active ingredient	Marketing
Morphine Sulfate15MG · tablet, extended release;oral	Morphine Sulfate	Discontinued

All 12 submissions, including labeling and manufacturing supplements


Dec 10, 2019	Supplement 21Labeling · Standard review	Approved	None posted
Dec 10, 2019	Supplement 23Labeling · Standard review	Approved	None posted
Dec 10, 2019	Supplement 24Labeling · Standard review	Approved	None posted
Sep 18, 2018	Supplement 22REMS	Approved	None posted
May 26, 2017	Supplement 20REMS	Approved	None posted
Sep 30, 2016	Supplement 19REMS	Approved	None posted
Apr 20, 2016	Supplement 18REMS	Approved	None posted
Jun 26, 2015	Supplement 16REMS	Approved	None posted
May 8, 2015	Supplement 12Labeling	Approved	None posted
Apr 22, 2015	Supplement 11Labeling	Approved	None posted
Jan 10, 2008	Supplement 7Labeling	Approved	None posted
May 19, 2004	Original application	Approved	Other

Identifiers

Application: ANDA 76733
Drugs@FDA: Overview at FDA
Company: Nesher Pharmaceuticals

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