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FDA Drug Approval, N217388, WAINUA (AUTOINJECTOR)
FDA Drug Approval, N217388, WAINUA (AUTOINJECTOR)
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NDA: 217388
Company: ASTRAZENECA AB
Drug Name: WAINUA (AUTOINJECTOR)
Active Ingredients: EPLONTERSEN SODIUM
Strength: EQ 45MG BASE/0.8ML (EQ 45MG BASE/0.8ML)
Dosage Form/Route: SOLUTION;SUBCUTANEOUS
Action Date: 12/21/2023
Marketing Status: Prescription
Submission Classification: Type 1 - New Molecular Entity
Company: ASTRAZENECA AB
Drug Name: WAINUA (AUTOINJECTOR)
Active Ingredients: EPLONTERSEN SODIUM
Strength: EQ 45MG BASE/0.8ML (EQ 45MG BASE/0.8ML)
Dosage Form/Route: SOLUTION;SUBCUTANEOUS
Action Date: 12/21/2023
Marketing Status: Prescription
Submission Classification: Type 1 - New Molecular Entity
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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