Active Ingredient: NITISINONE
Proprietary Name: ORFADIN
Dosage Form; Route of Administration: SUSPENSION; ORAL
Strength: 4MG/ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code:
Application Number: N206356
Product Number: 001
Approval Date: Apr 22, 2016
Applicant Holder Full Name: SWEDISH ORPHAN BIOVITRUM AB PUBL
Marketing Status:
Prescription
Patent and Exclusivity Information