Active Ingredient: SAPROPTERIN DIHYDROCHLORIDE
Proprietary Name: KUVAN
Dosage Form; Route of Administration: POWDER; ORAL
Strength: 100MG/PACKET
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N205065
Product Number: 001
Approval Date: Dec 19, 2013
Applicant Holder Full Name: BIOMARIN PHARMACEUTICAL INC
Marketing Status:
Prescription
Patent and Exclusivity Information
