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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 four suppliers. Additional details are available on the ARIXTRA profile page.

The generic ingredient in ARIXTRA is fondaparinux sodium. There are thirteen drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the fondaparinux sodium profile page.

Summary for NDA: 021345

Mylan Ireland Ltd
fondaparinux sodium
Therapeutic Class:Blood Products/Modifiers/ Volume Expanders
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
fondaparinux sodium
INJECTABLE;SUBCUTANEOUS 021345 NDA GlaxoSmithKline LLC 0007-3230 0007-3230-11 10 SYRINGE in 1 CARTON (0007-3230-11) > .5 mL in 1 SYRINGE
fondaparinux sodium
INJECTABLE;SUBCUTANEOUS 021345 NDA GlaxoSmithKline LLC 0007-3232 0007-3232-11 10 SYRINGE in 1 CARTON (0007-3232-11) > .4 mL in 1 SYRINGE

Summary for product number 001

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

Summary for product number 002

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

Summary for product number 003

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

Expired Orange Book Patents for NDA: 021345

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Mylan Ireland Ltd
fondaparinux sodium
INJECTABLE;SUBCUTANEOUS021345-001Dec 7, 20014,818,816<subscribe>
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