Morphine Sulfate

ANDA 208809, held by Hikma. Morphine Sulfate.

As of Nov 15, 2026, ANDA 208809 (Morphine Sulfate), held by Hikma, was first approved by FDA on Jul 6, 2017, with 5 approved supplements and 0 published complete response letters.

First approved: Jul 6, 2017
Review: Standard
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
Jul 6, 2017	Original application	Approved	REMS

Products

1 strengths and forms

Product	Active ingredient	Marketing
Morphine Sulfate100MG/5ML · solution;oral	Morphine Sulfate	Discontinued

All 6 submissions, including labeling and manufacturing supplements


Jun 18, 2026	Supplement 10REMS	Approved	None posted
Oct 31, 2024	Supplement 8REMS	Approved	None posted
Feb 10, 2020	Supplement 2Labeling · Standard review	Approved	None posted
Feb 10, 2020	Supplement 5Labeling · Standard review	Approved	None posted
Sep 18, 2018	Supplement 1REMS	Approved	None posted
Jul 6, 2017	Original application	Approved	REMS

Identifiers

Application: ANDA 208809
Drugs@FDA: Overview at FDA
Company: Hikma

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