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Generated: December 18, 2018

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Details for New Drug Application (NDA): 020298

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NDA 020298 describes ALOPRIM, which is a drug marketed by Mylan Institutional and is included in one NDA. It is available from two suppliers. Additional details are available on the ALOPRIM profile page.

The generic ingredient in ALOPRIM is allopurinol sodium. There are twenty-two drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the allopurinol sodium profile page.
Summary for 020298
Tradename:ALOPRIM
Applicant:Mylan Institutional
Ingredient:allopurinol sodium
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 020298
Mechanism of ActionXanthine Oxidase Inhibitors
Suppliers and Packaging for NDA: 020298
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ALOPRIM allopurinol sodium INJECTABLE;INJECTION 020298 NDA HF Acquisition Co LLC, DBA HealthFirst 51662-1323 51662-1323-1 1 KIT in 1 KIT (51662-1323-1) * 1 mL in 1 VIAL * 1 mL in 1 SYRINGE
ALOPRIM allopurinol sodium INJECTABLE;INJECTION 020298 NDA Mylan Institutional LLC 67457-187 67457-187-50 1 VIAL, GLASS in 1 CARTON (67457-187-50) > 25 mL in 1 VIAL, GLASS

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 500MG BASE/VIAL
Approval Date:May 17, 1996TE:APRLD:Yes

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