FDA Drug Approval, N213138, DIFICID
FDA Drug Approval, N213138, DIFICID
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NDA: 213138
Company: CUBIST PHARMS LLC
Drug Name: DIFICID
Active Ingredients: FIDAXOMICIN
Strength: 40MG/ML
Dosage Form/Route: FOR SUSPENSION;ORAL
Action Date: 01/24/2020
Marketing Status: Prescription
Submission Classification: Type 5 - New Formulation or New Manufacturer
Company: CUBIST PHARMS LLC
Drug Name: DIFICID
Active Ingredients: FIDAXOMICIN
Strength: 40MG/ML
Dosage Form/Route: FOR SUSPENSION;ORAL
Action Date: 01/24/2020
Marketing Status: Prescription
Submission Classification: Type 5 - New Formulation or New Manufacturer
- 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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