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FDA Drug Approval, N208193, OZOBAX DS
FDA Drug Approval, N208193, OZOBAX DS
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NDA: 208193
Company: METACEL PHARMS LLC
Drug Name: OZOBAX DS
Active Ingredients: BACLOFEN
Strength: 10MG/5ML
Dosage Form/Route: SOLUTION;ORAL
Action Date: 09/18/2019
Marketing Status: Prescription
Submission Classification: Type 3 - New Dosage Form
Company: METACEL PHARMS LLC
Drug Name: OZOBAX DS
Active Ingredients: BACLOFEN
Strength: 10MG/5ML
Dosage Form/Route: SOLUTION;ORAL
Action Date: 09/18/2019
Marketing Status: Prescription
Submission Classification: Type 3 - New Dosage Form
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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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