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Generated: June 17, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203154

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NDA 203154 describes ALLOPURINOL, which is a drug marketed by Accord Hlthcare, Apotex Inc, Fosun Pharma, Indoco Remedies, 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 Usa Inc, and West-ward Pharms Int, and is included in twenty-six NDAs. It is available from forty-five 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 203154
Tradename:ALLOPURINOL
Applicant:Accord Hlthcare
Ingredient:allopurinol
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 203154
Mechanism of ActionXanthine Oxidase Inhibitors
Medical Subject Heading (MeSH) Categories for 203154
Suppliers and Packaging for NDA: 203154
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ALLOPURINOL allopurinol TABLET;ORAL 203154 ANDA Accord Healthcare Inc. 16729-134 16729-134-01 100 TABLET in 1 BOTTLE (16729-134-01)
ALLOPURINOL allopurinol TABLET;ORAL 203154 ANDA Accord Healthcare Inc. 16729-134 16729-134-16 500 TABLET in 1 BOTTLE (16729-134-16)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength100MG
Approval Date:May 6, 2013TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength300MG
Approval Date:May 6, 2013TE:ABRLD:No

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