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FDA Orange Book · active-ingredient family

Cefotaxime sodium

Cefotaxime sodium is approved as 3 brand and 14 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:CLAFORAN · NDA 050547

3

Brand (NDA)

14

Generics (ANDA)

0

Listed patents

0

Exclusivity periods

Brand (NDA) products · injectable

ProductApplicantApplicationTEApproved
CLAFORANRLD×4STERIMAXNDA 050547—Approved Prior to Jan 1, 1982
CEFOTAXIME AND DEXTROSE 2.4% IN PLASTIC CONTAINER×2B BRAUNNDA 050792—Jul 29, 2004
CLAFORAN IN DEXTROSE 5% IN PLASTIC CONTAINER×4STERIMAXNDA 050596—May 20, 1985

Generic (ANDA) products (14)

ProductApplicantApplicationTEApproved
CEFOTAXIME SODIUM×2HOSPIRAANDA 203132—Feb 19, 2016
CEFOTAXIME SODIUMCEPHAZONE PHARMAANDA 065348—Jan 25, 2010
CEFOTAXIME SODIUM×3AUROBINDO PHARMAANDA 065517—Nov 06, 2009
CEFOTAXIME SODIUMAUROBINDO PHARMA LTDANDA 065516—Nov 06, 2009
CEFOTAXIME×3WOCKHARDTANDA 065197—Aug 29, 2006
CEFOTAXIME SODIUM×3HOSPIRA INCANDA 065290—Aug 11, 2006
CEFOTAXIME SODIUM×2HOSPIRA INCANDA 065293—Aug 10, 2006
CEFOTAXIME SODIUMHOSPIRA INCANDA 065292—Aug 10, 2006
CEFOTAXIME SODIUM×3LUPINANDA 065124—Sep 24, 2003
CEFOTAXIME×3HIKMAANDA 065072—Nov 20, 2002
CEFOTAXIMEHIKMAANDA 065071—Nov 20, 2002
CEFOTAXIME×3FRESENIUS KABI USAANDA 064200—Mar 24, 2000
CEFOTAXIME×2FRESENIUS KABI USAANDA 064201—Mar 24, 2000
CLAFORAN×2SANOFI AVENTIS USANDA 062659—Jan 13, 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.

Cefotaxime sodium — frequently asked questions

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

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