Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving hundreds of leading biopharmaceutical companies globally:

Generated: June 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 065048

« Back to Dashboard

NDA 065048 describes CEFUROXIME SODIUM, which is a drug marketed by Acs Dobfar Spa, Fresenius Kabi Usa, Hikma Farmaceutica, Hospira Inc, Teva Pharms, Watson Labs Inc, and Samson Medcl, and is included in fourteen NDAs. It is available from four suppliers. Additional details are available on the CEFUROXIME SODIUM profile page.

The generic ingredient in CEFUROXIME SODIUM is cefuroxime sodium. There are sixty-one drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the cefuroxime sodium profile page.

Summary for 065048

Tradename:	CEFUROXIME SODIUM
Applicant:	Hikma Farmaceutica
Ingredient:	cefuroxime sodium
Patents:	0
Formulation / Manufacturing:	see details

Pharmacology for NDA: 065048

Ingredient-type	Cephalosporins

Suppliers and Packaging for NDA: 065048

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CEFUROXIME SODIUM	cefuroxime sodium	INJECTABLE;INJECTION	065048	ANDA	West-Ward Pharmaceutical Corp	0143-9567	N	0143-9567-25
CEFUROXIME SODIUM	cefuroxime sodium	INJECTABLE;INJECTION	065048	ANDA	West-Ward Pharmaceutical Corp	0143-9568	N	0143-9568-25

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INTRAMUSCULAR, INTRAVENOUS			Strength	EQ 750MG BASE/VIAL
Approval Date:	Jan 9, 2004	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	EQ 1.5GM BASE/VIAL
Approval Date:	Jan 9, 2004	TE:	AP	RLD:	No

Complete Access Available with Subscription

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Johnson and Johnson

Fish and Richardson

Teva

Baxter

Cipla

Dow

Colorcon

Julphar

McKesson

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.