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Generated: November 19, 2018

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Details for New Drug Application (NDA): 065313

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NDA 065313 describes CEFOXITIN, which is a drug marketed by Acs Dobfar, Acs Dobfar Spa, Fresenius Kabi Usa, Hikma Farmaceutica, Hospira Inc, West-ward Pharms Int, B Braun, and Samson Medcl, and is included in fourteen NDAs. It is available from six suppliers. Additional details are available on the CEFOXITIN profile page.

The generic ingredient in CEFOXITIN is cefoxitin sodium. There are eight drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the cefoxitin sodium profile page.
Summary for 065313
Tradename:CEFOXITIN
Applicant:Hospira Inc
Ingredient:cefoxitin sodium
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 065313
Ingredient-typeCephalosporins
Medical Subject Heading (MeSH) Categories for 065313
Suppliers and Packaging for NDA: 065313
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CEFOXITIN cefoxitin sodium INJECTABLE;INJECTION 065313 ANDA Apotex Corporation 60505-0759 60505-0759-5 25 VIAL in 1 CARTON (60505-0759-5) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (60505-0759-1)
CEFOXITIN cefoxitin sodium INJECTABLE;INJECTION 065313 ANDA Apotex Corporation 60505-0760 60505-0760-5 25 VIAL in 1 CARTON (60505-0760-5) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (60505-0760-1)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 1GM BASE/VIAL
Approval Date:Jan 23, 2006TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 2GM BASE/VIAL
Approval Date:Jan 23, 2006TE:APRLD:No

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