Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 215014

EMPAVELI (PEGCETACOPLAN)
1080MG/20ML (54MG/ML)
Marketing Status: Prescription
Active Ingredient: PEGCETACOPLAN
Proprietary Name: EMPAVELI
Dosage Form; Route of Administration: SOLUTION; SUBCUTANEOUS
Strength: 1080MG/20ML (54MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N215014
Product Number: 001
Approval Date: May 14, 2021
Applicant Holder Full Name: APELLIS PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

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