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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 218037

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VOYDEYA (DANICOPAN)
50MG
Marketing Status: Prescription
Active Ingredient: DANICOPAN
Proprietary Name: VOYDEYA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 50MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N218037
Product Number: 001
Approval Date: Mar 29, 2024
Applicant Holder Full Name: ALEXION PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
VOYDEYA (DANICOPAN)
100MG
Marketing Status: Prescription
Active Ingredient: DANICOPAN
Proprietary Name: VOYDEYA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 100MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N218037
Product Number: 002
Approval Date: Mar 29, 2024
Applicant Holder Full Name: ALEXION PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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