Morphine Sulfate

ANDA 203519, held by Tris Pharma Inc. Morphine Sulfate.

As of Nov 15, 2026, ANDA 203519 (Morphine Sulfate), held by Tris Pharma Inc, was first approved by FDA on May 18, 2016, with 1 approved supplement and 0 published complete response letters.

First approved: May 18, 2016
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
May 18, 2016	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Morphine Sulfate20MG/5ML · solution;oral	Morphine Sulfate	Discontinued

All 2 submissions, including labeling and manufacturing supplements


Sep 18, 2018	Supplement 2REMS · Standard review	Approved	None posted
May 18, 2016	Original application	Approved	None posted

Identifiers

Application: ANDA 203519
Drugs@FDA: Overview at FDA
Company: Tris 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