Active Ingredient: CYSTEAMINE BITARTRATE
Proprietary Name: PROCYSBI
Dosage Form; Route of Administration: GRANULE, DELAYED RELEASE; ORAL
Strength: EQ 300MG BASE/PACKET
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code:
Application Number: N213491
Product Number: 002
Approval Date: Feb 14, 2020
Applicant Holder Full Name: HORIZON THERAPEUTICS USA INC
Marketing Status:
Prescription
Patent and Exclusivity Information