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FDA Drug Approval, N211801, IBSRELA
FDA Drug Approval, N211801, IBSRELA
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NDA: 211801
Company: ARDELYX INC
Drug Name: IBSRELA
Active Ingredients: TENAPANOR HYDROCHLORIDE
Strength: EQ 50MG BASE
Dosage Form/Route: TABLET;ORAL
Action Date: 09/12/2019
Marketing Status: Prescription
Submission Classification: Type 1 - New Molecular Entity
Company: ARDELYX INC
Drug Name: IBSRELA
Active Ingredients: TENAPANOR HYDROCHLORIDE
Strength: EQ 50MG BASE
Dosage Form/Route: TABLET;ORAL
Action Date: 09/12/2019
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 when the FOIA office is operating at regular capacity
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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