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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 Fresenius Kabi Usa, Hospira Inc, Acs Dobfar, Hikma Farmaceutica, Eurohlth Intl Sarl, 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: 065313

Tradename:
CEFOXITIN
Applicant:
Hospira Inc
Ingredient:
cefoxitin sodium
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 065313

Ingredient-typeCephalosporins

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)

Summary for product number 001

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

Summary 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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