Morphine Sulfate

ANDA 77855, held by Nesher Pharms. Morphine Sulfate.

As of Nov 15, 2026, ANDA 77855 (Morphine Sulfate), held by Nesher Pharms, was first approved by FDA on Sep 27, 2007, with 11 approved supplements and 0 published complete response letters.

First approved: Sep 27, 2007
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
Sep 27, 2007	Original application	Approved	None posted

Products

2 strengths and forms


Morphine Sulfate100MG · tablet, extended release;oral	Morphine Sulfate	Discontinued
Morphine Sulfate200MG · tablet, extended release;oral	Morphine Sulfate	Discontinued

All 12 submissions, including labeling and manufacturing supplements


Dec 10, 2019	Supplement 22Labeling · Standard review	Approved	None posted
Dec 10, 2019	Supplement 21Labeling · Standard review	Approved	None posted
Dec 10, 2019	Supplement 19Labeling · Standard review	Approved	None posted
Sep 18, 2018	Supplement 20REMS	Approved	None posted
May 26, 2017	Supplement 18REMS	Approved	None posted
Sep 30, 2016	Supplement 17REMS	Approved	None posted
Apr 20, 2016	Supplement 16REMS	Approved	None posted
Jun 26, 2015	Supplement 13REMS	Approved	None posted
May 8, 2015	Supplement 8Labeling	Approved	None posted
Apr 22, 2015	Supplement 7Labeling	Approved	None posted
Jan 10, 2008	Supplement 3Labeling	Approved	None posted
Sep 27, 2007	Original application	Approved	None posted

Identifiers

Application: ANDA 77855
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