Active Ingredient: FIDAXOMICIN
Proprietary Name: FIDAXOMICIN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 200MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A208443
Product Number: 001
Approval Date: Jan 16, 2024
Applicant Holder Full Name: ACTAVIS LABORATORIES FL INC AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC
Marketing Status:
Prescription
Patent and Exclusivity Information
