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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 207344

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MICAFUNGIN SODIUM (MICAFUNGIN SODIUM)
EQ 50MG BASE/VIAL
Marketing Status: Prescription
Active Ingredient: MICAFUNGIN SODIUM
Proprietary Name: MICAFUNGIN SODIUM
Dosage Form; Route of Administration: INJECTABLE; INTRAVENOUS
Strength: EQ 50MG BASE/VIAL
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A207344
Product Number: 001
Approval Date: May 17, 2019
Applicant Holder Full Name: FRESENIUS KABI USA LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
MICAFUNGIN SODIUM (MICAFUNGIN SODIUM)
EQ 100MG BASE/VIAL
Marketing Status: Prescription
Active Ingredient: MICAFUNGIN SODIUM
Proprietary Name: MICAFUNGIN SODIUM
Dosage Form; Route of Administration: INJECTABLE; INTRAVENOUS
Strength: EQ 100MG BASE/VIAL
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A207344
Product Number: 002
Approval Date: May 17, 2019
Applicant Holder Full Name: FRESENIUS KABI USA LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
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