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Generated: October 20, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 065247

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NDA 065247 describes CEFAZOLIN SODIUM, which is a drug marketed by Acs Dobfar, Facta Farma, West-ward Pharms Int, Steri Pharma, Teva Pharms, Hospira Inc, Sandoz, Glaxosmithkline, Samson Medcl, Hikma Farmaceutica, Qilu Pharm Co Ltd, Fresenius Kabi Usa, Cephazone Pharma, Abraxis Pharm, Watson Labs Inc, Bedford, and Aurobindo Pharma, and is included in thirty-one NDAs. It is available from seventeen suppliers. Additional details are available on the CEFAZOLIN SODIUM profile page.

The generic ingredient in CEFAZOLIN SODIUM is cefazolin sodium. There are twenty-seven drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the cefazolin sodium profile page.

Summary for NDA: 065247

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

Pharmacology for NDA: 065247

Ingredient-typeCephalosporins

Suppliers and Packaging for NDA: 065247

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CEFAZOLIN SODIUM
cefazolin sodium
INJECTABLE;INJECTION 065247 ANDA Hospira, Inc. 0409-0806 0409-0806-01 10 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (0409-0806-01) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, PHARMACY BULK PACKAGE (0409-0806-11)
CEFAZOLIN SODIUM
cefazolin sodium
INJECTABLE;INJECTION 065247 ANDA Apotex Corporation 60505-0769 60505-0769-0 10 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (60505-0769-0) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, PHARMACY BULK PACKAGE (60505-0769-1)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 10GM BASE/VIAL
Approval Date:Aug 12, 2005TE:APRLD:No


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