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Generated: November 19, 2018

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Details for New Drug Application (NDA): 205919

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NDA 205919 describes PURIXAN, which is a drug marketed by Nova Labs Ltd and is included in one NDA. It is available from one supplier. Additional details are available on the PURIXAN profile page.

The generic ingredient in PURIXAN is mercaptopurine. There are ten drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the mercaptopurine profile page.
Summary for 205919
Tradename:PURIXAN
Applicant:Nova Labs Ltd
Ingredient:mercaptopurine
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 205919
Suppliers and Packaging for NDA: 205919
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PURIXAN mercaptopurine SUSPENSION;ORAL 205919 NDA Nova Laboratories, Ltd 62484-0020 62484-0020-2 1 BOTTLE in 1 CARTON (62484-0020-2) > 100 mL in 1 BOTTLE (62484-0020-1)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION;ORALStrength20MG/ML
Approval Date:Apr 28, 2014TE:RLD:Yes
Regulatory Exclusivity Expiration:Apr 28, 2021
Regulatory Exclusivity Use:TREATMENT OF PATIENTS WITH ACUTE LYMPHOBLASTIC LEUKEMIA AS PART OF A COMBINATION REGIMEN.

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