Details for New Drug Application (NDA): 212061

NDA 212061 describes HEPARIN SODIUM, which is a drug marketed by Abraxis Pharm, Aspen Global Inc, B Braun Medical, Be Pharms, Casi Pharms Inc, Chamberlin Parenterl, Dell Labs, Dr Reddys, Emerge Bioscience, Epic Pharma Llc, Fresenius Kabi Usa, Gland, Hikma, Hospira, Hospira Inc, Lilly, Luitpold, Parke Davis, Pfizer, Pharm Spec, Pharmacia And Upjohn, Pharmobedient, Plano Pharms, Sagent Pharms, 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 twenty-two 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-four suppliers are listed for this compound. Additional details are available on the heparin sodium profile page.

Summary for 212061

Tradename:	HEPARIN SODIUM
Applicant:	Emerge Bioscience
Ingredient:	heparin sodium
Patents:	0

Pharmacology for NDA: 212061

Suppliers and Packaging for NDA: 212061

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
HEPARIN SODIUM	heparin sodium	INJECTABLE;INJECTION	212061	ANDA	Meitheal Pharmaceuticals Inc.	71288-406	71288-406-82	24 BLISTER PACK in 1 CARTON (71288-406-82) / 1 SYRINGE, GLASS in 1 BLISTER PACK / 1 mL in 1 SYRINGE, GLASS (71288-406-81)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	5,000 UNITS/ML
Approval Date:	Jul 15, 2020	TE:	AP	RLD:	No

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