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FDA Drug Approval, N016295, HYDREA
FDA Drug Approval, N016295, HYDREA
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NDA: 016295
Company: CHEPLAPHARM
Drug Name: HYDREA
Active Ingredients: HYDROXYUREA
Strength: CAPSULE;ORAL
Dosage Form/Route: Prescription
Action Date: ORIG-1
Marketing Status: AB
Submission Classification: PRIORITY
Company: CHEPLAPHARM
Drug Name: HYDREA
Active Ingredients: HYDROXYUREA
Strength: CAPSULE;ORAL
Dosage Form/Route: Prescription
Action Date: ORIG-1
Marketing Status: AB
Submission Classification: PRIORITY
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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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