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FDA Drug Approval, N211150, WAKIX
FDA Drug Approval, N211150, WAKIX
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NDA: 211150
Company: HARMONY
Drug Name: WAKIX
Active Ingredients: PITOLISANT HYDROCHLORIDE
Strength: EQ 17.8MG BASE
Dosage Form/Route: TABLET;ORAL
Action Date: 08/14/2019
Marketing Status: Prescription
Submission Classification: Type 1 - New Molecular Entity
Company: HARMONY
Drug Name: WAKIX
Active Ingredients: PITOLISANT HYDROCHLORIDE
Strength: EQ 17.8MG BASE
Dosage Form/Route: TABLET;ORAL
Action Date: 08/14/2019
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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