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FDA Drug Approval, N215935, TARPEYO
FDA Drug Approval, N215935, TARPEYO
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NDA: 215935
Company: CALLIDITAS
Drug Name: TARPEYO
Active Ingredients: BUDESONIDE
Strength: 4MG
Dosage Form/Route: CAPSULE, DELAYED RELEASE;ORAL
Action Date: 12/15/2021
Marketing Status: Prescription
Submission Classification: Type 5 - New Formulation or New Manufacturer
Company: CALLIDITAS
Drug Name: TARPEYO
Active Ingredients: BUDESONIDE
Strength: 4MG
Dosage Form/Route: CAPSULE, DELAYED RELEASE;ORAL
Action Date: 12/15/2021
Marketing Status: Prescription
Submission Classification: Type 5 - New Formulation or New Manufacturer
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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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