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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 one supplier. 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. Eight suppliers are listed for this compound. Additional details are available on the mercaptopurine profile page.

Summary for NDA: 009053

Tradename:
PURINETHOL
Applicant:
Stason Pharms
Ingredient:
mercaptopurine
Patents:0
Therapeutic Class:Antineoplastics
Formulation / Manufacturing:see details

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 AUTHORIZED GENERIC Quinn Pharmaceuticals, LLC 69076-913 69076-913-02 25 TABLET in 1 BOTTLE, PLASTIC (69076-913-02)
PURINETHOL
mercaptopurine
TABLET;ORAL 009053 NDA AUTHORIZED GENERIC Quinn Pharmaceuticals, LLC 69076-913 69076-913-25 250 TABLET in 1 BOTTLE, PLASTIC (69076-913-25)

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:No


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