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FDA Orange Book · active-ingredient family

Cefazolin sodium

Cefazolin sodium is approved as 6 brand and 35 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:CEFAZOLIN SODIUM · NDA 211413

6

Brand (NDA)

35

Generics (ANDA)

0

Listed patents

0

Exclusivity periods

Brand (NDA) products · injectable, powder, solution

ProductApplicantApplicationTEApproved
CEFAZOLIN SODIUMRLD×2HQ SPCLT PHARMANDA 211413—May 08, 2023
CEFAZOLIN SODIUMRLD×2HIKMANDA 216109—Oct 07, 2022
CEFAZOLIN IN DEXTROSERLD×3BAXTER HLTHCARE CORPNDA 207131—Feb 01, 2021
CEFAZOLIN AND DEXTROSERLD×4B BRAUNNDA 050779—Jul 27, 2000
ANCEF IN DEXTROSE 5% IN PLASTIC CONTAINERRLD×4BAXTER HLTHCARENDA 050566—Jun 08, 1983
ANCEFRLD×5GLAXOSMITHKLINENDA 050461—Approved Prior to Jan 1, 1982

Generic (ANDA) products (35)

ProductApplicantApplicationTEApproved
CEFAZOLIN SODIUMQILU ANTIBIOTICSANDA 209217APOct 17, 2018
CEFAZOLIN SODIUMHOSPIRAANDA 201654—Feb 03, 2016
CEFAZOLIN SODIUM×3QILU ANTIBIOTICSANDA 203661APDec 28, 2015
CEFAZOLIN SODIUM×2CEPHAZONE PHARMAANDA 065280—Mar 18, 2009
CEFAZOLIN SODIUMCEPHAZONE PHARMAANDA 065295—Mar 18, 2009
CEFAZOLIN SODIUMCEPHAZONE PHARMAANDA 065296—Mar 18, 2009
CEFAZOLIN SODIUM×2ACS DOBFARANDA 065303APOct 22, 2008
CEFAZOLIN SODIUM×2ACS DOBFARANDA 065306APOct 22, 2008
CEFAZOLIN SODIUM×2AUROBINDO PHARMAANDA 065395—Aug 08, 2008
CEFAZOLIN SODIUMSANDOZANDA 065345—May 09, 2007
CEFAZOLIN SODIUM×2SAMSON MEDCLANDA 065141—Nov 29, 2006
CEFAZOLIN SODIUMHOSPIRA INCANDA 065244—Aug 12, 2005
CEFAZOLIN SODIUMHOSPIRA INCANDA 065247—Aug 12, 2005
CEFAZOLIN SODIUM×2HOSPIRA INCANDA 065226—Apr 21, 2005
CEFAZOLIN SODIUMHIKMA FARMACEUTICAANDA 065143APOct 18, 2004
CEFAZOLIN SODIUM×2HIKMA FARMACEUTICAANDA 065047APSep 18, 2001
CEFAZOLIN SODIUM×2FRESENIUS KABI USAANDA 064169—Aug 14, 1998
CEFAZOLIN SODIUM×2FRESENIUS KABI USAANDA 064170—Mar 18, 1998
CEFAZOLIN SODIUMGLAXOSMITHKLINEANDA 064033—Oct 31, 1993
CEFAZOLIN SODIUMFACTA FARMAANDA 063207—Dec 27, 1991
CEFAZOLIN SODIUM×2FACTA FARMAANDA 063209—Dec 27, 1991
CEFAZOLIN SODIUMFACTA FARMAANDA 063214—Dec 27, 1991
CEFAZOLIN SODIUMSTERI PHARMAANDA 063208—Dec 27, 1991
CEFAZOLIN SODIUMSTERI PHARMAANDA 063216—Dec 27, 1991
ANCEF IN PLASTIC CONTAINER×2BAXTER HLTHCAREANDA 063002—Mar 28, 1991
CEFAZOLIN SODIUM×2TEVA PHARMSANDA 063018—Mar 05, 1990
CEFAZOLIN SODIUM×3DR REDDYSANDA 062988—Dec 29, 1989
CEFAZOLIN SODIUM×3DR REDDYSANDA 062989—Dec 29, 1989
CEFAZOLIN SODIUM×3TEVA PHARMSANDA 063016—Mar 14, 1989
CEFAZOLIN SODIUM×3SANDOZANDA 062831APDec 09, 1988
CEFAZOLIN SODIUM×5BEDFORDANDA 062894—Jul 21, 1988
CEFAZOLIN SODIUM×6HIKMAANDA 062807—Jan 12, 1988
CEFAZOLIN SODIUM×4ABRAXIS PHARMANDA 062688—Nov 17, 1986
KEFZOL×2LILLYANDA 062557—Sep 10, 1985
KEFZOL×5ACS DOBFARANDA 061773—Approved Prior to Jan 1, 1982

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.

Cefazolin sodium — frequently asked questions

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

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