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Last Updated: April 3, 2025

Details for New Drug Application (NDA): 218312

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NDA 218312 describes FONDAPARINUX SODIUM, which is a drug marketed by Brightgene, Dr Reddys Labs Ltd, Eugia Pharma, Hangzhou Zhongmei, Hengrui Pharma, and Scinopharm Taiwan, and is included in six 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 218312

Tradename:	FONDAPARINUX SODIUM
Applicant:	Brightgene
Ingredient:	fondaparinux sodium
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;SUBCUTANEOUS			Strength	2.5MG/0.5ML
Approval Date:	Dec 18, 2024	TE:	AP	RLD:	No

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