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Last Updated: November 24, 2024

Details for New Drug Application (NDA): 018877


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NDA 018877 describes ALLOPURINOL, which is a drug marketed by Accord Hlthcare, Aiping Pharm Inc, Chartwell, Endo Operations, Harman Finochem, Hetero Labs Ltd V, Indoco, Ipca Labs Ltd, Lupin Ltd, Mutual Pharm, Mylan, Northstar Hlthcare, Puracap Pharm, Purepac Pharm, Sandoz, Sun Pharm Inds Inc, Sun Pharm Industries, Superpharm, Unichem, Watson Labs, Zydus Pharms, Gland Pharma Ltd, and Hikma, and is included in thirty NDAs. It is available from thirty-nine suppliers. Additional details are available on the ALLOPURINOL profile page.

The generic ingredient in ALLOPURINOL is allopurinol sodium. There are twenty-two drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the allopurinol sodium profile page.
Summary for 018877
Tradename:ALLOPURINOL
Applicant:Watson Labs
Ingredient:allopurinol
Patents:0
Pharmacology for NDA: 018877
Mechanism of ActionXanthine Oxidase Inhibitors
Medical Subject Heading (MeSH) Categories for 018877
Suppliers and Packaging for NDA: 018877
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ALLOPURINOL allopurinol TABLET;ORAL 018877 NDA Actavis Pharma, Inc. 0591-5544 0591-5544-01 100 TABLET in 1 BOTTLE, PLASTIC (0591-5544-01)
ALLOPURINOL allopurinol TABLET;ORAL 018877 NDA Actavis Pharma, Inc. 0591-5544 0591-5544-05 500 TABLET in 1 BOTTLE, PLASTIC (0591-5544-05)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength300MG
Approval Date:Sep 28, 1984TE:ABRLD:No

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