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Generated: August 22, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 065048

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NDA 065048 describes CEFUROXIME SODIUM, which is a drug marketed by Fresenius Kabi Usa, Hospira Inc, Facta Farma, Watson Labs Inc, Hikma Farmaceutica, Teva Pharms, 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. Five suppliers are listed for this compound. Additional details are available on the cefuroxime sodium profile page.

Summary for NDA: 065048

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 065048

Ingredient-typeCephalosporins

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 0143-9567-25 25 VIAL in 1 CARTON (0143-9567-25) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (0143-9567-01)
CEFUROXIME SODIUM
cefuroxime sodium
INJECTABLE;INJECTION 065048 ANDA West-Ward Pharmaceutical Corp 0143-9568 0143-9568-25 25 VIAL in 1 CARTON (0143-9568-25) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (0143-9568-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAMUSCULAR, INTRAVENOUSStrengthEQ 750MG BASE/VIAL
Approval Date:Jan 9, 2004TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 1.5GM BASE/VIAL
Approval Date:Jan 9, 2004TE:APRLD:No


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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.

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