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Last Updated: April 2, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203661


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NDA 203661 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 Farmaceutica, Hospira Inc, Qilu, Samson Medcl, Sandoz, Steri Pharma, Teva Pharms, and West-ward Pharms Int, and is included in thirty-two NDAs. It is available from fourteen 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. Sixteen suppliers are listed for this compound. Additional details are available on the cefazolin sodium profile page.
Summary for 203661
Tradename:CEFAZOLIN SODIUM
Applicant:Qilu
Ingredient:cefazolin sodium
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 203661
Medical Subject Heading (MeSH) Categories for 203661
Suppliers and Packaging for NDA: 203661
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CEFAZOLIN SODIUM cefazolin sodium INJECTABLE;INJECTION 203661 ANDA General Injectables & Vaccines, Inc. 52584-087 52584-087-00 1 VIAL, SINGLE-DOSE in 1 BAG (52584-087-00) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE
CEFAZOLIN SODIUM cefazolin sodium INJECTABLE;INJECTION 203661 ANDA Apotex Corp. 60505-6142 60505-6142-5 25 VIAL, SINGLE-DOSE in 1 CARTON (60505-6142-5) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (60505-6142-0)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 1GM BASE/VIAL
Approval Date:Dec 28, 2015TE:APRLD:No

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