Morphine Sulfate

ANDA 205509, held by Ani Pharms. Morphine Sulfate.

As of Nov 15, 2026, ANDA 205509 (Morphine Sulfate), held by Ani Pharms, was first approved by FDA on Apr 17, 2018, with 3 approved supplements and 0 published complete response letters.

First approved: Apr 17, 2018
Review: Standard
Supplements approved: 3
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below

Date	Submission	Status	Documents
Apr 17, 2018	Original application	Approved	REMS Letter

Products

3 strengths and forms


Morphine Sulfate10MG/5ML · solution;oral	Morphine Sulfate	Discontinued
Morphine Sulfate20MG/5ML · solution;oral	Morphine Sulfate	Discontinued
Morphine Sulfate100MG/5ML · solution;oral	Morphine Sulfate	Discontinued

All 4 submissions, including labeling and manufacturing supplements


Jun 18, 2026	Supplement 7REMS	Approved	None posted
Oct 31, 2024	Supplement 6REMS	Approved	None posted
Sep 18, 2018	Supplement 1REMS	Approved	None posted
Apr 17, 2018	Original application	Approved	REMS Letter

Identifiers

Application: ANDA 205509
Drugs@FDA: Overview at FDA
Company: ANI 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