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FDA Drug Approval, N019594, ACTIGALL
FDA Drug Approval, N019594, ACTIGALL
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NDA: 019594
Company: TEVA BRANDED PHARM
Drug Name: ACTIGALL
Active Ingredients: URSODIOL
Strength: CAPSULE;ORAL
Dosage Form/Route: Prescription
Action Date: ORIG-1
Marketing Status: AB
Submission Classification: PRIORITY; Orphan
Company: TEVA BRANDED PHARM
Drug Name: ACTIGALL
Active Ingredients: URSODIOL
Strength: CAPSULE;ORAL
Dosage Form/Route: Prescription
Action Date: ORIG-1
Marketing Status: AB
Submission Classification: PRIORITY; Orphan
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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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