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FDA Orange Book · active-ingredient family

Cefoxitin sodium

Cefoxitin sodium is approved as 3 brand and 15 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:CEFOXITIN AND DEXTROSE IN DUPLEX CONTAINER · NDA 065214

3

Brand (NDA)

15

Generics (ANDA)

0

Listed patents

0

Exclusivity periods

Brand (NDA) products · injectable, powder

ProductApplicantApplicationTEApproved
CEFOXITIN AND DEXTROSE IN DUPLEX CONTAINERRLD×2B BRAUNNDA 065214APMar 10, 2006
MEFOXIN IN DEXTROSE 5% IN PLASTIC CONTAINERRLD×4MERCKNDA 050581—Sep 20, 1984
MEFOXINRLD×3PHARMOBEDIENTNDA 050517—Approved Prior to Jan 1, 1982

Generic (ANDA) products (15)

ProductApplicantApplicationTEApproved
CEFOXITIN IN PLASTIC CONTAINERSAMSON MEDCLANDA 200938—Nov 16, 2015
CEFOXITIN×2ACS DOBFAR SPAANDA 065467—Aug 31, 2011
CEFOXITINACS DOBFAR SPAANDA 065464—Aug 31, 2011
CEFOXITINACS DOBFARANDA 065415APMay 19, 2010
CEFOXITIN×2HIKMA FARMACEUTICAANDA 065238APMar 12, 2010
CEFOXITINHIKMA FARMACEUTICAANDA 065239APMar 02, 2010
CEFOXITIN×2ACS DOBFARANDA 065414APJun 12, 2009
CEFOXITINHOSPIRA INCANDA 065312—Feb 13, 2006
CEFOXITIN×2HOSPIRA INCANDA 065313—Jan 23, 2006
CEFOXITIN×2HIKMAANDA 065051APSep 11, 2000
CEFOXITINHIKMAANDA 065050APSep 11, 2000
CEFOXITIN×2FRESENIUS KABI USAANDA 065012—Jul 03, 2000
CEFOXITINFRESENIUS KABI USAANDA 065011—Jul 03, 2000
MEFOXIN IN PLASTIC CONTAINER×2PHARMOBEDIENTANDA 063182—Jan 25, 1993
MEFOXIN×2PHARMOBEDIENTANDA 062757—Jan 08, 1987

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Cefoxitin sodium — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

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