Details for New Drug Application (NDA): 017029

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NDA 017029 describes HEPARIN SODIUM PRESERVATIVE FREE, which is a drug marketed by Dr Reddys, Fresenius Kabi Usa, Hospira, Nanjing King-friend, Pfizer, Pharma Serve Ny, Sagent Pharms, and Shenzhen Techdow, and is included in nine NDAs. It is available from twelve suppliers. Additional details are available on the HEPARIN SODIUM PRESERVATIVE FREE profile page.

The generic ingredient in HEPARIN SODIUM PRESERVATIVE FREE is heparin sodium. There are seventy-seven drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the heparin sodium profile page.

Tradename:	HEPARIN SODIUM PRESERVATIVE FREE
Applicant:	Fresenius Kabi Usa
Ingredient:	heparin sodium
Patents:	0

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
HEPARIN SODIUM	heparin sodium	INJECTABLE;INJECTION	017029	NDA	Henry Schein, Inc.	0404-9979	0404-9979-01	1 VIAL, MULTI-DOSE in 1 BAG (0404-9979-01) / 1 mL in 1 VIAL, MULTI-DOSE
HEPARIN SODIUM	heparin sodium	INJECTABLE;INJECTION	017029	NDA	HF Acquisition Co LLC, DBA HealthFirst	51662-1409	51662-1409-1	5 mL in 1 VIAL (51662-1409-1)

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	1,000 UNITS/ML
Approval Date:	Approved Prior to Jan 1, 1982	TE:	AP	RLD:	Yes

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	5,000 UNITS/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	No

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	10,000 UNITS/ML
Approval Date:	Approved Prior to Jan 1, 1982	TE:	AP	RLD:	Yes

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