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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 three suppliers. 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. Four suppliers are listed for this compound. Additional details are available on the fondaparinux sodium profile page.

Summary for NDA: 021345

Tradename:
ARIXTRA
Applicant:
Mylan Ireland Ltd
Ingredient:
fondaparinux sodium
Patents:0
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
ARIXTRA
fondaparinux sodium
INJECTABLE;SUBCUTANEOUS 021345 NDA Physicians Total Care, Inc. 54868-5501 54868-5501-0 10 SYRINGE in 1 CARTON (54868-5501-0) > .6 mL in 1 SYRINGE
ARIXTRA
fondaparinux sodium
INJECTABLE;SUBCUTANEOUS 021345 NDA Apotex Corp. 60505-6078 60505-6078-4 10 SYRINGE in 1 CARTON (60505-6078-4) > .5 mL in 1 SYRINGE (60505-6078-0)

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
ARIXTRA
fondaparinux sodium
INJECTABLE;SUBCUTANEOUS021345-001Dec 7, 20014,818,816► subscribe
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