Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 214938

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VOXZOGO (VOSORITIDE)
0.4MG/VIAL
Marketing Status: Prescription

Active Ingredient: VOSORITIDE
Proprietary Name: VOXZOGO
Dosage Form; Route of Administration: POWDER; SUBCUTANEOUS
Strength: 0.4MG/VIAL
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N214938
Product Number: 001
Approval Date: Nov 19, 2021
Applicant Holder Full Name: BIOMARIN PHARMACEUTICAL INC
Marketing Status:  Prescription
Patent and Exclusivity Information

VOXZOGO (VOSORITIDE)
0.56MG/VIAL
Marketing Status: Prescription

Active Ingredient: VOSORITIDE
Proprietary Name: VOXZOGO
Dosage Form; Route of Administration: POWDER; SUBCUTANEOUS
Strength: 0.56MG/VIAL
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N214938
Product Number: 002
Approval Date: Nov 19, 2021
Applicant Holder Full Name: BIOMARIN PHARMACEUTICAL INC
Marketing Status:  Prescription
Patent and Exclusivity Information

VOXZOGO (VOSORITIDE)
1.2MG/VIAL
Marketing Status: Prescription

Active Ingredient: VOSORITIDE
Proprietary Name: VOXZOGO
Dosage Form; Route of Administration: POWDER; SUBCUTANEOUS
Strength: 1.2MG/VIAL
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N214938
Product Number: 003
Approval Date: Nov 19, 2021
Applicant Holder Full Name: BIOMARIN PHARMACEUTICAL INC
Marketing Status:  Prescription
Patent and Exclusivity Information