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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 217388

WAINUA (AUTOINJECTOR) (EPLONTERSEN SODIUM)
EQ 45MG BASE/0.8ML (EQ 45MG BASE/0.8ML)
Marketing Status: Prescription
Active Ingredient: EPLONTERSEN SODIUM
Proprietary Name: WAINUA (AUTOINJECTOR)
Dosage Form; Route of Administration: SOLUTION; SUBCUTANEOUS
Strength: EQ 45MG BASE/0.8ML (EQ 45MG BASE/0.8ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N217388
Product Number: 001
Approval Date: Dec 21, 2023
Applicant Holder Full Name: ASTRAZENECA AB
Marketing Status:  Prescription
Patent and Exclusivity Information
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