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Last Updated: December 7, 2023

Details for New Drug Application (NDA): 021345

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NDA 021345 describes ARIXTRA, which is a drug marketed by Mylan Ireland Ltd and is included in one NDA. It is available from one supplier. Additional details are available on the ARIXTRA profile page.

The generic ingredient in ARIXTRA is fondaparinux sodium. There are fourteen drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the fondaparinux sodium profile page.
Summary for 021345
Applicant:Mylan Ireland Ltd
Ingredient:fondaparinux sodium
Formulation / Manufacturing:see details
Pharmacology for NDA: 021345
Mechanism of ActionFactor Xa Inhibitors
Suppliers and Packaging for NDA: 021345
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ARIXTRA fondaparinux sodium INJECTABLE;SUBCUTANEOUS 021345 NDA AUTHORIZED GENERIC Mylan Institutional LLC 67457-582 67457-582-10 10 SYRINGE in 1 CARTON (67457-582-10) / .5 mL in 1 SYRINGE (67457-582-00)
ARIXTRA fondaparinux sodium INJECTABLE;SUBCUTANEOUS 021345 NDA AUTHORIZED GENERIC Mylan Institutional LLC 67457-583 67457-583-04 10 SYRINGE in 1 CARTON (67457-583-04) / .4 mL in 1 SYRINGE (67457-583-00)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;SUBCUTANEOUSStrength2.5MG/0.5ML
Approval Date:Dec 7, 2001TE:APRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;SUBCUTANEOUSStrength5MG/0.4ML
Approval Date:May 28, 2004TE:APRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;SUBCUTANEOUSStrength7.5MG/0.6ML
Approval Date:May 28, 2004TE:APRLD:Yes

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