Morphine Sulfate

ANDA 206308, held by Rhodes Pharms. Morphine Sulfate.

As of Nov 15, 2026, ANDA 206308 (Morphine Sulfate), held by Rhodes Pharms, was first approved by FDA on Jun 22, 2017, with 2 approved supplements and 0 published complete response letters.

First approved: Jun 22, 2017
Review: Standard
Supplements approved: 2
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below

Date	Submission	Status	Documents
Jun 22, 2017	Original application	Approved	REMS Letter

Products

2 strengths and forms


Morphine Sulfate10MG/5ML · solution;oral	Morphine Sulfate	Discontinued
Morphine Sulfate100MG/5ML · solution;oral	Morphine Sulfate	Discontinued

All 3 submissions, including labeling and manufacturing supplements


Jun 18, 2026	Supplement 4REMS	Approved	None posted
Sep 18, 2018	Supplement 1REMS	Approved	None posted
Jun 22, 2017	Original application	Approved	REMS Letter

Identifiers

Application: ANDA 206308
Drugs@FDA: Overview at FDA
Company: Rhodes 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