Details for New Drug Application (NDA): 091316

NDA 091316 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 five 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. Six suppliers are listed for this compound. Additional details are available on the fondaparinux sodium profile page.

Summary for 091316

Tradename:	FONDAPARINUX SODIUM
Applicant:	Dr Reddys Labs Ltd
Ingredient:	fondaparinux sodium
Patents:	0

Pharmacology for NDA: 091316

Mechanism of Action

Factor Xa Inhibitors

Suppliers and Packaging for NDA: 091316

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
FONDAPARINUX SODIUM	fondaparinux sodium	INJECTABLE;SUBCUTANEOUS	091316	ANDA	Dr. Reddy's Laboratories Limited	55111-678	55111-678-02	2 SYRINGE in 1 CARTON (55111-678-02) / .5 mL in 1 SYRINGE (55111-678-11)
FONDAPARINUX SODIUM	fondaparinux sodium	INJECTABLE;SUBCUTANEOUS	091316	ANDA	Dr. Reddy's Laboratories Limited	55111-678	55111-678-10	10 SYRINGE in 1 CARTON (55111-678-10) / .5 mL in 1 SYRINGE (55111-678-11)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;SUBCUTANEOUS			Strength	2.5MG/0.5ML
Approval Date:	Jul 11, 2011	TE:	AP	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;SUBCUTANEOUS			Strength	5MG/0.4ML
Approval Date:	Jul 11, 2011	TE:	AP	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;SUBCUTANEOUS			Strength	7.5MG/0.6ML
Approval Date:	Jul 11, 2011	TE:	AP	RLD:	No

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