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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 216493

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NDA 216493 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 216493

Tradename:	FONDAPARINUX SODIUM
Applicant:	Hangzhou Zhongmei
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:	Aug 19, 2024	TE:	AP	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;SUBCUTANEOUS			Strength	5MG/0.4ML
Approval Date:	Aug 19, 2024	TE:	AP	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;SUBCUTANEOUS			Strength	7.5MG/0.6ML
Approval Date:	Aug 19, 2024	TE:	AP	RLD:	No

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