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Product Details for NDA 213138

DIFICID (FIDAXOMICIN)
40MG/ML
Marketing Status: Prescription
Active Ingredient: FIDAXOMICIN
Proprietary Name: DIFICID
Dosage Form; Route of Administration: FOR SUSPENSION; ORAL
Strength: 40MG/ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N213138
Product Number: 001
Approval Date: Jan 24, 2020
Applicant Holder Full Name: CUBIST PHARMACEUTICALS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
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