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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 205065

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KUVAN (SAPROPTERIN DIHYDROCHLORIDE)
100MG/PACKET
Marketing Status: Prescription
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
KUVAN (SAPROPTERIN DIHYDROCHLORIDE)
500MG/PACKET
Marketing Status: Prescription
Active Ingredient: SAPROPTERIN DIHYDROCHLORIDE
Proprietary Name: KUVAN
Dosage Form; Route of Administration: POWDER; ORAL
Strength: 500MG/PACKET
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N205065
Product Number: 002
Approval Date: Oct 27, 2015
Applicant Holder Full Name: BIOMARIN PHARMACEUTICAL INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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