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Last Updated: September 26, 2020

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Details for New Drug Application (NDA): 078390

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NDA 078390 describes ALLOPURINOL, which is a drug marketed by Accord Hlthcare, Apotex Inc, Fosun Pharma, Indoco, Ipca Labs Ltd, Mutual Pharm, Mylan, Northstar Hlthcare, Puracap Pharm, Purepac Pharm, Sandoz, Sun Pharm Inds Inc, Sun Pharm Industries, Superpharm, Unichem Labs Ltd, Vintage Pharms, Watson Labs, Zydus Pharms, and West-ward Pharms Int, and is included in twenty-six NDAs. It is available from thirty-six 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. Three suppliers are listed for this compound. Additional details are available on the allopurinol sodium profile page.
Summary for 078390
Tradename:ALLOPURINOL
Applicant:Sun Pharm Inds Inc
Ingredient:allopurinol
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 078390

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength100MG
Approval Date:Aug 30, 2007TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength300MG
Approval Date:Aug 30, 2007TE:RLD:No

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