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Last Updated: November 21, 2024

Details for New Drug Application (NDA): 211713


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NDA 211713 describes MICAFUNGIN SODIUM, which is a drug marketed by Apotex, Biocon Pharma, Fresenius Kabi Usa, Hikma, Jiangsu Hansoh Pharm, Meitheal, Xellia Pharms Aps, and Zydus Pharms, and is included in eight NDAs. It is available from ten suppliers. Additional details are available on the MICAFUNGIN SODIUM profile page.

The generic ingredient in MICAFUNGIN SODIUM is micafungin sodium. There are eight drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the micafungin sodium profile page.
Summary for 211713
Tradename:MICAFUNGIN SODIUM
Applicant:Xellia Pharms Aps
Ingredient:micafungin sodium
Patents:0
Pharmacology for NDA: 211713
Suppliers and Packaging for NDA: 211713
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MICAFUNGIN SODIUM micafungin sodium INJECTABLE;INTRAVENOUS 211713 ANDA Xellia Pharmaceuticals USA LLC 70594-036 70594-036-01 1 VIAL, GLASS in 1 CARTON (70594-036-01) / 5 mL in 1 VIAL, GLASS
MICAFUNGIN SODIUM micafungin sodium INJECTABLE;INTRAVENOUS 211713 ANDA Xellia Pharmaceuticals USA LLC 70594-037 70594-037-01 1 VIAL, GLASS in 1 CARTON (70594-037-01) / 5 mL in 1 VIAL, GLASS

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAVENOUSStrengthEQ 50MG BASE/VIAL
Approval Date:Jun 2, 2021TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAVENOUSStrengthEQ 100MG BASE/VIAL
Approval Date:Jun 2, 2021TE:APRLD:No

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