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FDA NDA · NDA020298

ALOPRIM

allopurinol

Sponsor: MYLAN

APPLICATION
NDA020298
TYPE
NDA
ORIGINAL APPROVAL
1996-05-17
LATEST ACTION
2022-02-17
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

ALOPRIM · ReferencePrescription
ALLOPURINOL SODIUM EQ 500MG BASE/VIAL · INJECTABLE · INJECTION

Approval history

2022-02-17Labeling · Supplement 12 · standard — Patient Package Insert ↗AP
2020-12-16Labeling · Supplement 13 · standard — Letter ↗AP
2020-08-28Labeling · Supplement 10 · standard — Letter ↗AP
2015-05-13Manufacturing (CMC) · Supplement 6 · priorityAP
2013-08-09Manufacturing (CMC) · Supplement 5 · priorityAP
2000-05-12Labeling · Supplement 1 · standard — Label ↗AP
2000-01-28Manufacturing (CMC) · Supplement 2 · priorityAP
1996-05-17Type 3 - New Dosage Form · Original · priorityAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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