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Last Updated: March 19, 2024

Details for New Drug Application (NDA): 065141


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NDA 065141 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 065141
Tradename:CEFAZOLIN SODIUM
Applicant:Samson Medcl
Ingredient:cefazolin sodium
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 065141
Medical Subject Heading (MeSH) Categories for 065141
Suppliers and Packaging for NDA: 065141
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CEFAZOLIN SODIUM cefazolin sodium INJECTABLE;INJECTION 065141 ANDA Samson Medical Technologies, L.L.C. 66288-1100 66288-1100-1 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 BAG (66288-1100-1)
CEFAZOLIN SODIUM cefazolin sodium INJECTABLE;INJECTION 065141 ANDA Samson Medical Technologies, L.L.C. 66288-1300 66288-1300-1 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 BAG (66288-1300-1)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 100GM BASE/VIAL
Approval Date:Nov 29, 2006TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 300GM BASE/VIAL
Approval Date:Nov 29, 2006TE:RLD:No

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