Morphine Sulfate

ANDA 91357, held by Epic Pharma LLC. Morphine Sulfate.

As of Nov 15, 2026, ANDA 91357 (Morphine Sulfate), held by Epic Pharma LLC, was first approved by FDA on Jun 23, 2016, with 5 approved supplements and 0 published complete response letters.

First approved: Jun 23, 2016
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
Jun 23, 2016	Original application	Approved	Other

Products

5 strengths and forms


Morphine Sulfate15MG · tablet, extended release;oral	Morphine Sulfate	Discontinued
Morphine Sulfate30MG · tablet, extended release;oral	Morphine Sulfate	Discontinued
Morphine Sulfate60MG · tablet, extended release;oral	Morphine Sulfate	Discontinued
Morphine Sulfate100MG · tablet, extended release;oral	Morphine Sulfate	Discontinued
Morphine Sulfate200MG · tablet, extended release;oral	Morphine Sulfate	Discontinued

All 6 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 4REMS	Approved	None posted
May 26, 2017	Supplement 3REMS	Approved	None posted
Sep 30, 2016	Supplement 1REMS	Approved	None posted
Jun 23, 2016	Original application	Approved	Other

Identifiers

Application: ANDA 91357
Drugs@FDA: Overview at FDA
Company: Epic Pharma

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