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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 064170


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NDA 064170 describes CEFAZOLIN SODIUM, which is a drug marketed by Abraxis Pharm, Acs Dobfar, Aurobindo Pharma, Bedford, Cephazone Pharma, Dr Reddys, Facta Farma, Fresenius Kabi Usa, Glaxosmithkline, Hikma, Hikma Farmaceutica, Hospira, Hospira Inc, Qilu, Samson Medcl, Sandoz, Steri Pharma, Teva Pharms, and Hq Spclt Pharma, and is included in thirty-four NDAs. It is available from nineteen 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-one suppliers are listed for this compound. Additional details are available on the cefazolin sodium profile page.
Summary for 064170
Tradename:CEFAZOLIN SODIUM
Applicant:Fresenius Kabi Usa
Ingredient:cefazolin sodium
Patents:0
Medical Subject Heading (MeSH) Categories for 064170

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrengthEQ 10GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Mar 18, 1998TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrengthEQ 20GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Mar 18, 1998TE:RLD:No

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