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Generated: May 22, 2017

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Details for New Drug Application (NDA): 065312

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NDA 065312 describes CEFOXITIN, which is a drug marketed by Fresenius Kabi Usa, Hospira Inc, Acs Dobfar, Hikma Farmaceutica, West-ward Pharms Int, Acs Dobfar Spa, B Braun, and Samson Medcl, and is included in fourteen NDAs. It is available from seven 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. Nine suppliers are listed for this compound. Additional details are available on the cefoxitin sodium profile page.

Summary for NDA: 065312

Formulation / Manufacturing:see details

Pharmacology for NDA: 065312


Suppliers and Packaging for NDA: 065312

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
cefoxitin sodium
INJECTABLE;INJECTION 065312 ANDA Apotex Corporation 60505-0761 60505-0761-4 10 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (60505-0761-4) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, PHARMACY BULK PACKAGE (60505-0761-1)

Summary for product number 001

Approval Date:Feb 13, 2006TE:APRLD:No

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