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Last Updated: April 25, 2024

Details for New Drug Application (NDA): 009053

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NDA 009053 describes PURINETHOL, which is a drug marketed by Stason Pharms and is included in one NDA. It is available from two suppliers. Additional details are available on the PURINETHOL profile page.

The generic ingredient in PURINETHOL is mercaptopurine. There are ten drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the mercaptopurine profile page.
Summary for 009053
Applicant:Stason Pharms
Formulation / Manufacturing:see details
Pharmacology for NDA: 009053
Suppliers and Packaging for NDA: 009053
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PURINETHOL mercaptopurine TABLET;ORAL 009053 NDA Stason Pharmaceuticals, Inc. 60763-601 60763-601-13 25 TABLET in 1 BOTTLE, PLASTIC (60763-601-13)
PURINETHOL mercaptopurine TABLET;ORAL 009053 NDA AUTHORIZED GENERIC Quinn Pharmaceuticals 69076-913 69076-913-02 25 TABLET in 1 BOTTLE, PLASTIC (69076-913-02)

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:Yes

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