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Generated: July 17, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 064125

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NDA 064125 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 064125
Tradename:CEFUROXIME SODIUM
Applicant:Acs Dobfar Spa
Ingredient:cefuroxime sodium
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 064125
Ingredient-typeCephalosporins
Suppliers and Packaging for NDA: 064125
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CEFUROXIME SODIUM cefuroxime sodium INJECTABLE;INJECTION 064125 ANDA Sagent Pharmaceuticals 25021-118 N 25021-118-10
CEFUROXIME SODIUM cefuroxime sodium INJECTABLE;INJECTION 064125 ANDA Sagent Pharmaceuticals 25021-119 N 25021-119-20

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAMUSCULAR, INTRAVENOUSStrengthEQ 750MG BASE/VIAL
Approval Date:May 30, 1997TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 1.5GM BASE/VIAL
Approval Date:May 30, 1997TE:APRLD:No

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Covington
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