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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 213137

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OXBRYTA (VOXELOTOR)
300MG
Marketing Status: Prescription
Active Ingredient: VOXELOTOR
Proprietary Name: OXBRYTA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 300MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N213137
Product Number: 002
Approval Date: Oct 14, 2022
Applicant Holder Full Name: GLOBAL BLOOD THERAPEUTICS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
OXBRYTA (VOXELOTOR)
500MG
Marketing Status: Prescription
Active Ingredient: VOXELOTOR
Proprietary Name: OXBRYTA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 500MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N213137
Product Number: 001
Approval Date: Nov 25, 2019
Applicant Holder Full Name: GLOBAL BLOOD THERAPEUTICS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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