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Last Updated: March 29, 2024

Details for New Drug Application (NDA): 018659


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NDA 018659 describes ALLOPURINOL, which is a drug marketed by Accord Hlthcare, Aiping Pharm Inc, Chartwell, 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, Vintage Pharms, Watson Labs, Zydus Pharms, Gland Pharma Ltd, and Hikma, and is included in thirty NDAs. It is available from forty 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 018659
Tradename:ALLOPURINOL
Applicant:Mylan
Ingredient:allopurinol
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 018659
Mechanism of ActionXanthine Oxidase Inhibitors
Medical Subject Heading (MeSH) Categories for 018659
Suppliers and Packaging for NDA: 018659
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ALLOPURINOL allopurinol TABLET;ORAL 018659 ANDA Mylan Pharmaceuticals Inc. 0378-0137 0378-0137-01 100 TABLET in 1 BOTTLE (0378-0137-01)
ALLOPURINOL allopurinol TABLET;ORAL 018659 ANDA Mylan Pharmaceuticals Inc. 0378-0137 0378-0137-10 1000 TABLET in 1 BOTTLE (0378-0137-10)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength100MG
Approval Date:Oct 24, 1986TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength300MG
Approval Date:Oct 24, 1986TE:ABRLD:No

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