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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 216962

VYALEV (FOSCARBIDOPA; FOSLEVODOPA)
120MG/10ML;2400MG/10ML (12MG/ML;240MG/ML)
Marketing Status: Prescription
Active Ingredient: FOSCARBIDOPA; FOSLEVODOPA
Proprietary Name: VYALEV
Dosage Form; Route of Administration: SOLUTION; SUBCUTANEOUS
Strength: 120MG/10ML;2400MG/10ML (12MG/ML;240MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N216962
Product Number: 001
Approval Date: Oct 16, 2024
Applicant Holder Full Name: ABBVIE INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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