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Generated: February 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 062831

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NDA 062831 describes CEFAZOLIN SODIUM, which is a drug marketed by Abraxis Pharm, Acs Dobfar, Aurobindo Pharma, Bedford, Cephazone Pharma, Facta Farma, Fresenius Kabi Usa, Glaxosmithkline, Hikma Farmaceutica, Hospira Inc, Qilu Pharm Co Ltd, Samson Medcl, Sandoz, Steri Pharma, Teva Pharms, Watson Labs Inc, and West-ward Pharms Int, and is included in thirty-one NDAs. It is available from sixteen 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. Eighteen suppliers are listed for this compound. Additional details are available on the cefazolin sodium profile page.
Summary for 062831
Tradename:CEFAZOLIN SODIUM
Applicant:Sandoz
Ingredient:cefazolin sodium
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 062831
Ingredient-typeCephalosporins
Medical Subject Heading (MeSH) Categories for 062831
Suppliers and Packaging for NDA: 062831
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CEFAZOLIN SODIUM cefazolin sodium INJECTABLE;INJECTION 062831 ANDA Sandoz Inc 0781-3450 N 0781-3450-95
CEFAZOLIN SODIUM cefazolin sodium INJECTABLE;INJECTION 062831 ANDA Sandoz Inc 0781-3451 N 0781-3451-96

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 500MG BASE/VIAL
Approval Date:Dec 9, 1988TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 1GM BASE/VIAL
Approval Date:Dec 9, 1988TE:APRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 10GM BASE/VIAL
Approval Date:Sep 25, 1992TE:APRLD:No

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