Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 213674

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XTANDI (ENZALUTAMIDE)
40MG
Marketing Status: Prescription

Active Ingredient: ENZALUTAMIDE
Proprietary Name: XTANDI
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 40MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N213674
Product Number: 001
Approval Date: Aug 4, 2020
Applicant Holder Full Name: ASTELLAS PHARMA US INC
Marketing Status:  Prescription
Patent and Exclusivity Information

XTANDI (ENZALUTAMIDE)
80MG
Marketing Status: Prescription

Active Ingredient: ENZALUTAMIDE
Proprietary Name: XTANDI
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 80MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N213674
Product Number: 002
Approval Date: Aug 4, 2020
Applicant Holder Full Name: ASTELLAS PHARMA US INC
Marketing Status:  Prescription
Patent and Exclusivity Information