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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 216157

OXBRYTA (VOXELOTOR)
300MG
Marketing Status: Prescription
Active Ingredient: VOXELOTOR
Proprietary Name: OXBRYTA
Dosage Form; Route of Administration: TABLET, FOR SUSPENSION; ORAL
Strength: 300MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N216157
Product Number: 001
Approval Date: Dec 17, 2021
Applicant Holder Full Name: GLOBAL BLOOD THERAPEUTICS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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