Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 215192

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VAFSEO (VADADUSTAT)
150MG
Marketing Status: Prescription

Active Ingredient: VADADUSTAT
Proprietary Name: VAFSEO
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 150MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N215192
Product Number: 001
Approval Date: Mar 27, 2024
Applicant Holder Full Name: AKEBIA THERAPEUTICS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

VAFSEO (VADADUSTAT)
300MG
Marketing Status: Prescription

Active Ingredient: VADADUSTAT
Proprietary Name: VAFSEO
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 300MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N215192
Product Number: 002
Approval Date: Mar 27, 2024
Applicant Holder Full Name: AKEBIA THERAPEUTICS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

VAFSEO (VADADUSTAT)
450MG
Marketing Status: Prescription

Active Ingredient: VADADUSTAT
Proprietary Name: VAFSEO
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 450MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N215192
Product Number: 003
Approval Date: Mar 27, 2024
Applicant Holder Full Name: AKEBIA THERAPEUTICS INC
Marketing Status:  Prescription
Patent and Exclusivity Information