You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: November 5, 2024

Details for New Drug Application (NDA): 211713


✉ Email this page to a colleague

« Back to Dashboard


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

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.