Details for New Drug Application (NDA): 206812

NDA 206812 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 206812

Tradename:	FONDAPARINUX SODIUM
Applicant:	Hengrui Pharma
Ingredient:	fondaparinux sodium
Patents:	0

Pharmacology for NDA: 206812

Mechanism of Action

Factor Xa Inhibitors

Suppliers and Packaging for NDA: 206812

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
FONDAPARINUX SODIUM	fondaparinux sodium	INJECTABLE;SUBCUTANEOUS	206812	ANDA	Sandoz Inc.	0781-3443	0781-3443-12	2 SYRINGE in 1 CARTON (0781-3443-12) / .5 mL in 1 SYRINGE (0781-3443-94)
FONDAPARINUX SODIUM	fondaparinux sodium	INJECTABLE;SUBCUTANEOUS	206812	ANDA	Sandoz Inc.	0781-3443	0781-3443-95	10 SYRINGE in 1 CARTON (0781-3443-95) / .5 mL in 1 SYRINGE (0781-3443-94)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;SUBCUTANEOUS			Strength	2.5MG/0.5ML
Approval Date:	May 15, 2018	TE:	AP	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;SUBCUTANEOUS			Strength	5MG/0.4ML
Approval Date:	May 15, 2018	TE:	AP	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;SUBCUTANEOUS			Strength	7.5MG/0.6ML
Approval Date:	May 15, 2018	TE:	AP	RLD:	No

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