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Last Updated: April 18, 2024

Details for New Drug Application (NDA): 017651

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NDA 017651 describes HEPARIN SODIUM, which is a drug marketed by Abraxis Pharm, B Braun Medical Inc, Be Pharms, Casi Pharms Inc, Chamberlin Parenterl, Dell Labs, Dr Reddys, Epic Pharma Llc, Fresenius Kabi Usa, Gland, Hikma, Hospira, Hospira Inc, Lilly, Luitpold, Mylan Labs Ltd, Nanjing King-friend, Organon Usa Inc, Parke Davis, Pfizer, Pharm Spec, Pharmacia And Upjohn, Sagent Pharms, Sandoz, Shenzhen Techdow, Smith And Nephew, Solopak, Watson Labs Inc, Baxter Hlthcare, Mcgaw, B Braun, and Pharma Serve Ny, and is included in sixty-nine NDAs. It is available from eighteen suppliers. Additional details are available on the HEPARIN SODIUM profile page.

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

Summary for 017651

Tradename:	HEPARIN SODIUM
Applicant:	Fresenius Kabi Usa
Ingredient:	heparin sodium
Patents:	0
Formulation / Manufacturing:	see details

Pharmacology for NDA: 017651

Suppliers and Packaging for NDA: 017651

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
HEPARIN SODIUM	heparin sodium	INJECTABLE;INJECTION	017651	NDA	Fresenius Kabi USA, LLC	63323-047	63323-047-10	25 VIAL in 1 TRAY (63323-047-10) / 10 mL in 1 VIAL (63323-047-01)

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	10,000 UNITS/ML
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	No

Profile for product number 005

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	1,000 UNITS/ML
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	No

Profile for product number 006

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	5,000 UNITS/ML
Approval Date:	Approved Prior to Jan 1, 1982	TE:	AP	RLD:	Yes

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