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Details for New Drug Application (NDA): 090637

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NDA 090637 describes ALLOPURINOL, which is a drug marketed by Watson Labs, Ipca Labs Ltd, Puracap Pharm, Mutual Pharm, Sun Pharm Inds, Superpharm, Apotex Inc, Northstar Hlthcare, Accord Hlthcare, Mylan, Indoco Remedies, Sandoz, Purepac Pharm, Sun Pharm Inds Inc, Vintage Pharms, and Eurohlth Intl Sarl, and is included in twenty-five NDAs. It is available from thirty-seven suppliers. Additional details are available on the ALLOPURINOL profile page.

The generic ingredient in ALLOPURINOL is allopurinol sodium. There are twenty-one drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the allopurinol sodium profile page.

Summary for NDA: 090637

Ipca Labs Ltd
Therapeutic Class:Antigout Agents

Pharmacology for NDA: 090637

Mechanism of ActionXanthine Oxidase Inhibitors

Suppliers and Packaging for NDA: 090637

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TABLET;ORAL 090637 ANDA Blenheim Pharmacal, Inc. 10544-545 10544-545-30 30 TABLET in 1 BOTTLE (10544-545-30)
TABLET;ORAL 090637 ANDA Blenheim Pharmacal, Inc. 10544-545 10544-545-90 90 TABLET in 1 BOTTLE (10544-545-90)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength100MG
Approval Date:Mar 16, 2011TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength300MG
Approval Date:Mar 16, 2011TE:ABRLD:No

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