Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 212156

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MICAFUNGIN (MICAFUNGIN SODIUM)
EQ 50MG BASE/VIAL
Marketing Status: Prescription

Active Ingredient: MICAFUNGIN SODIUM
Proprietary Name: MICAFUNGIN
Dosage Form; Route of Administration: POWDER; INTRAVENOUS
Strength: EQ 50MG BASE/VIAL
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N212156
Product Number: 001
Approval Date: Jun 16, 2021
Applicant Holder Full Name: PAR STERILE PRODUCTS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

MICAFUNGIN (MICAFUNGIN SODIUM)
EQ 100MG BASE/VIAL
Marketing Status: Prescription

Active Ingredient: MICAFUNGIN SODIUM
Proprietary Name: MICAFUNGIN
Dosage Form; Route of Administration: POWDER; INTRAVENOUS
Strength: EQ 100MG BASE/VIAL
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N212156
Product Number: 002
Approval Date: Jun 16, 2021
Applicant Holder Full Name: PAR STERILE PRODUCTS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information