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Last Updated: November 22, 2024

Details for New Drug Application (NDA): 208615


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NDA 208615 describes FONDAPARINUX SODIUM, which is a drug marketed by Dr Reddys Labs Ltd, Eugia Pharma, Hangzhou Zhongmei, Hengrui Pharma, and Scinopharm Taiwan, and is included in five NDAs. It is available from six suppliers. Additional details are available on the FONDAPARINUX SODIUM profile page.

The generic ingredient in FONDAPARINUX SODIUM 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 208615
Tradename:FONDAPARINUX SODIUM
Applicant:Scinopharm Taiwan
Ingredient:fondaparinux sodium
Patents:0
Pharmacology for NDA: 208615
Mechanism of ActionFactor Xa Inhibitors
Suppliers and Packaging for NDA: 208615
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FONDAPARINUX SODIUM fondaparinux sodium INJECTABLE;SUBCUTANEOUS 208615 ANDA Italfarmaco S.p.A 11797-154 11797-154-06 10 SYRINGE in 1 CARTON (11797-154-06) / .5 mL in 1 SYRINGE (11797-154-02)
FONDAPARINUX SODIUM fondaparinux sodium INJECTABLE;SUBCUTANEOUS 208615 ANDA Italfarmaco S.p.A 11797-154 11797-154-09 2 SYRINGE in 1 CARTON (11797-154-09) / .5 mL in 1 SYRINGE (11797-154-02)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;SUBCUTANEOUSStrength2.5MG/0.5ML
Approval Date:Nov 14, 2018TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;SUBCUTANEOUSStrength5MG/0.4ML
Approval Date:Nov 14, 2018TE:APRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;SUBCUTANEOUSStrength7.5MG/0.6ML
Approval Date:Nov 14, 2018TE:APRLD:No

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