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Last Updated: April 19, 2024

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

Tradename:	ARIXTRA
Applicant:	Mylan Ireland Ltd
Ingredient:	fondaparinux sodium
Patents:	0
Formulation / Manufacturing:	see details

Pharmacology for NDA: 021345

Mechanism of Action	Factor 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:	RX	Dosage:	INJECTABLE;SUBCUTANEOUS			Strength	2.5MG/0.5ML
Approval Date:	Dec 7, 2001	TE:	AP	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;SUBCUTANEOUS			Strength	5MG/0.4ML
Approval Date:	May 28, 2004	TE:	AP	RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;SUBCUTANEOUS			Strength	7.5MG/0.6ML
Approval Date:	May 28, 2004	TE:	AP	RLD:	Yes

Expired US Patents for NDA 021345

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Mylan Ireland Ltd	ARIXTRA	fondaparinux sodium	INJECTABLE;SUBCUTANEOUS	021345-001	Dec 7, 2001	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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