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Generated: April 24, 2018

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 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 two 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. Two suppliers are listed for this compound. Additional details are available on the cefuroxime sodium profile page.
Summary for 065048
Applicant:Hikma Farmaceutica
Ingredient:cefuroxime sodium
Formulation / Manufacturing:see details
Pharmacology for NDA: 065048
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

Approval Date:Jan 9, 2004TE:ABRLD:No

Profile 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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