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Generated: November 17, 2018

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Details for New Drug Application (NDA): 071586

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NDA 071586 describes LOPURIN, which is a drug marketed by Abbott and Dr Reddys La and is included in three NDAs. It is available from seven suppliers. Additional details are available on the LOPURIN profile page.

The generic ingredient in LOPURIN is allopurinol. There are twenty-two drug master file entries for this compound. Fifty suppliers are listed for this compound. Additional details are available on the allopurinol profile page.
Summary for 071586
Tradename:LOPURIN
Applicant:Dr Reddys La
Ingredient:allopurinol
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 071586
Mechanism of ActionXanthine Oxidase Inhibitors
Medical Subject Heading (MeSH) Categories for 071586
Suppliers and Packaging for NDA: 071586
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LOPURIN allopurinol TABLET;ORAL 071586 ANDA Major Pharmaceuticals 0904-6266 0904-6266-61 100 TABLET, COATED in 1 BOX, UNIT-DOSE (0904-6266-61)
LOPURIN allopurinol TABLET;ORAL 071586 ANDA Unit Dose Services 50436-3027 50436-3027-1 30 TABLET in 1 BOTTLE (50436-3027-1)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength100MG
Approval Date:Apr 2, 1987TE:ABRLD:No

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