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Serving leading biopharmaceutical companies globally:

Baxter
US Department of Justice
Julphar
Fuji
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Federal Trade Commission
Citi
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Generated: October 20, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 065306

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NDA 065306 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 eighteen 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. Twenty suppliers are listed for this compound. Additional details are available on the cefazolin sodium profile page.

Summary for NDA: 065306

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

Pharmacology for NDA: 065306

Ingredient-typeCephalosporins

Suppliers and Packaging for NDA: 065306

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CEFAZOLIN SODIUM
cefazolin sodium
INJECTABLE;INJECTION 065306 ANDA Sagent Pharmaceuticals 25021-102 25021-102-69 10 BOTTLE in 1 CARTON (25021-102-69) > 1 INJECTION, POWDER, FOR SOLUTION in 1 BOTTLE
CEFAZOLIN SODIUM
cefazolin sodium
INJECTABLE;INJECTION 065306 ANDA Sagent Pharmaceuticals 25021-102 25021-102-99 10 BOTTLE in 1 CARTON (25021-102-99) > 1 INJECTION, POWDER, FOR SOLUTION in 1 BOTTLE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 10GM BASE/VIAL
Approval Date:Oct 22, 2008TE:APRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 20GM BASE/VIAL
Approval Date:Aug 18, 2014TE:APRLD:No


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Serving leading biopharmaceutical companies globally:

Farmers Insurance
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Boehringer Ingelheim
Julphar
Fuji
Chinese Patent Office
Harvard Business School
Healthtrust
Novartis
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