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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 216834

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ZILBRYSQ (ZILUCOPLAN SODIUM)
EQ 16.6MG BASE/0.416ML (EQ 16.6MG BASE/0.416ML)
Marketing Status: Prescription
Active Ingredient: ZILUCOPLAN SODIUM
Proprietary Name: ZILBRYSQ
Dosage Form; Route of Administration: SOLUTION; SUBCUTANEOUS
Strength: EQ 16.6MG BASE/0.416ML (EQ 16.6MG BASE/0.416ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N216834
Product Number: 001
Approval Date: Oct 17, 2023
Applicant Holder Full Name: UCB INC
Marketing Status:  Prescription
Patent and Exclusivity Information
ZILBRYSQ (ZILUCOPLAN SODIUM)
EQ 23MG BASE/0.574ML (EQ 23MG BASE/0.574ML)
Marketing Status: Prescription
Active Ingredient: ZILUCOPLAN SODIUM
Proprietary Name: ZILBRYSQ
Dosage Form; Route of Administration: SOLUTION; SUBCUTANEOUS
Strength: EQ 23MG BASE/0.574ML (EQ 23MG BASE/0.574ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N216834
Product Number: 002
Approval Date: Oct 17, 2023
Applicant Holder Full Name: UCB INC
Marketing Status:  Prescription
Patent and Exclusivity Information
ZILBRYSQ (ZILUCOPLAN SODIUM)
EQ 32.4MG BASE/0.81ML (EQ 32.4 BASE/0.81ML)
Marketing Status: Prescription
Active Ingredient: ZILUCOPLAN SODIUM
Proprietary Name: ZILBRYSQ
Dosage Form; Route of Administration: SOLUTION; SUBCUTANEOUS
Strength: EQ 32.4MG BASE/0.81ML (EQ 32.4 BASE/0.81ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N216834
Product Number: 003
Approval Date: Oct 17, 2023
Applicant Holder Full Name: UCB INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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