Aloprim

Manages leukemia, lymphoma, and solid tumor malignancies. NDA 20298, held by Mylan. Allopurinol Sodium.

As of Nov 13, 2026, NDA 20298 (Aloprim), held by Mylan, was first approved by FDA on May 17, 1996, with 7 approved supplements and 0 published complete response letters.

First approved: May 17, 1996
Review: Priority
Supplements approved: 7
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

ALOPRIM is indicated for the management of adult and pediatric patients with leukemia, lymphoma, and solid tumor malignancies who are receiving cancer therapy which causes elevations of serum and urinary uric acid levels and who cannot tolerate oral therapy.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 8 submissions below

Date	Submission	Status	Documents
May 17, 1996	Original applicationNew dosage form · Priority review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
AloprimEQ 500MG BASE/VIAL · injectable;injection	Allopurinol Sodium	RxReference drug

All 8 submissions, including labeling and manufacturing supplements


Feb 17, 2022	Supplement 12Labeling · Standard review	Approved	Label Patient Package Insert Letter
Dec 16, 2020	Supplement 13Labeling · Standard review	Approved	Label Letter
Aug 28, 2020	Supplement 10Labeling · Standard review	Approved	Label Letter
May 13, 2015	Supplement 6Manufacturing · Priority review	Approved	None posted
Aug 9, 2013	Supplement 5Manufacturing · Priority review	Approved	None posted
May 12, 2000	Supplement 1Labeling · Standard review	Approved	Label
Jan 28, 2000	Supplement 2Manufacturing · Priority review	Approved	None posted
May 17, 1996	Original applicationNew dosage form · Priority review	Approved	None posted

Identifiers

Application: NDA 20298
Drugs@FDA: Overview at FDA
Company: Mylan

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