Morphine Sulfate

ANDA 201947, held by Vistapharm. Morphine Sulfate.

As of Nov 15, 2026, ANDA 201947 (Morphine Sulfate), held by Vistapharm, was first approved by FDA on Jan 5, 2012, with 1 approved supplement and 0 published complete response letters.

First approved: Jan 5, 2012
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
Jan 5, 2012	Original application	Approved	None posted

Products

2 strengths and forms


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

All 2 submissions, including labeling and manufacturing supplements


Sep 18, 2018	Supplement 4REMS	Approved	None posted
Jan 5, 2012	Original application	Approved	None posted

Identifiers

Application: ANDA 201947
Drugs@FDA: Overview at FDA
Company: VistaPharm

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