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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 213491

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PROCYSBI (CYSTEAMINE BITARTRATE)
EQ 75MG BASE/PACKET
Marketing Status: Prescription
Active Ingredient: CYSTEAMINE BITARTRATE
Proprietary Name: PROCYSBI
Dosage Form; Route of Administration: GRANULE, DELAYED RELEASE; ORAL
Strength: EQ 75MG BASE/PACKET
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N213491
Product Number: 001
Approval Date: Feb 14, 2020
Applicant Holder Full Name: HORIZON THERAPEUTICS USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information
PROCYSBI (CYSTEAMINE BITARTRATE)
EQ 300MG BASE/PACKET
Marketing Status: Prescription
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
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