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Details for New Drug Application (NDA): 040528

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NDA 040528 describes MERCAPTOPURINE, which is a drug marketed by Roxane, Dr Reddys Labs Intl, and Mylan, and is included in three NDAs. It is available from six suppliers. Additional details are available on the MERCAPTOPURINE profile page.

The generic ingredient in MERCAPTOPURINE 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: 040528

Therapeutic Class:Antineoplastics

Pharmacology for NDA: 040528

Suppliers and Packaging for NDA: 040528

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TABLET;ORAL 040528 ANDA West-Ward Pharmaceuticals Corp. 0054-4581 0054-4581-11 25 TABLET in 1 BOTTLE, PLASTIC (0054-4581-11)
TABLET;ORAL 040528 ANDA West-Ward Pharmaceuticals Corp. 0054-4581 0054-4581-27 250 TABLET in 1 BOTTLE, PLASTIC (0054-4581-27)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG
Approval Date:Feb 13, 2004TE:ABRLD:Yes

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