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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 209217


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NDA 209217 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 209217
Tradename:CEFAZOLIN SODIUM
Applicant:Qilu
Ingredient:cefazolin sodium
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 209217
Medical Subject Heading (MeSH) Categories for 209217
Suppliers and Packaging for NDA: 209217
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CEFAZOLIN SODIUM cefazolin sodium INJECTABLE;INJECTION 209217 ANDA Apotex Corp. 60505-6143 60505-6143-4 10 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (60505-6143-4) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, PHARMACY BULK PACKAGE (60505-6143-0)
CEFAZOLIN SODIUM cefazolin sodium INJECTABLE;INJECTION 209217 ANDA Apotex Corp. 60505-6244 60505-6244-4 10 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (60505-6244-4) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, PHARMACY BULK PACKAGE (60505-6244-0)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 10GM BASE/VIAL
Approval Date:Oct 17, 2018TE:APRLD:No

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