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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021856

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ULORIC (FEBUXOSTAT)
40MG
Marketing Status: Prescription
Active Ingredient: FEBUXOSTAT
Proprietary Name: ULORIC
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 40MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021856
Product Number: 001
Approval Date: Feb 13, 2009
Applicant Holder Full Name: TAKEDA PHARMACEUTICALS USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information
ULORIC (FEBUXOSTAT)
80MG
Marketing Status: Prescription
Active Ingredient: FEBUXOSTAT
Proprietary Name: ULORIC
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 80MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N021856
Product Number: 002
Approval Date: Feb 13, 2009
Applicant Holder Full Name: TAKEDA PHARMACEUTICALS USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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