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Novartis
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US Department of Justice
Harvard Business School
Baxter
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Generated: October 20, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 064124

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NDA 064124 describes CEFUROXIME SODIUM, which is a drug marketed by Fresenius Kabi Usa, Hospira Inc, Acs Dobfar Spa, 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: 064124

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

Pharmacology for NDA: 064124

Ingredient-typeCephalosporins

Suppliers and Packaging for NDA: 064124

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CEFUROXIME SODIUM
cefuroxime sodium
INJECTABLE;INJECTION 064124 ANDA WG Critical Care, LLC 44567-712 44567-712-10 10 VIAL in 1 CARTON (44567-712-10) > 80 mL in 1 VIAL
CEFUROXIME SODIUM
cefuroxime sodium
INJECTABLE;INJECTION 064124 ANDA APP Pharmaceuticals, LLC 63323-354 63323-354-45 10 VIAL in 1 CARTON (63323-354-45) > 80 mL in 1 VIAL

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 7.5GM BASE/VIAL
Approval Date:May 30, 1997TE:APRLD:No


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Serving leading biopharmaceutical companies globally:

AstraZeneca
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Chinese Patent Office

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