Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 210951

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ERLEADA (APALUTAMIDE)
60MG
Marketing Status: Prescription

Active Ingredient: APALUTAMIDE
Proprietary Name: ERLEADA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 60MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N210951
Product Number: 001
Approval Date: Feb 14, 2018
Applicant Holder Full Name: JANSSEN BIOTECH INC
Marketing Status:  Prescription
Patent and Exclusivity Information

ERLEADA (APALUTAMIDE)
240MG
Marketing Status: Prescription

Active Ingredient: APALUTAMIDE
Proprietary Name: ERLEADA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 240MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N210951
Product Number: 002
Approval Date: Feb 17, 2023
Applicant Holder Full Name: JANSSEN BIOTECH INC
Marketing Status:  Prescription
Patent and Exclusivity Information