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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

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 Physicians Total Care, Inc. 54868-5501 54868-5501-0 10 SYRINGE in 1 CARTON (54868-5501-0) > .6 mL in 1 SYRINGE
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

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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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 verifification 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.