Treats serious infections caused by susceptible strains of the designated microorganisms…. NDA 50547, held by Sterimax. Cefotaxime Sodium.
As of Nov 14, 2026, NDA 50547 (Claforan), held by Sterimax, was first approved by FDA on Mar 11, 1981, with 53 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Treatment CLAFORAN is indicated for the treatment of patients with serious infections caused by susceptible strains of the designated microorganisms in the diseases listed below. Lower respiratory tract infections, including pneumonia, caused by Streptococcus pneumoniae, Streptococcus pyogenes * (Group A streptococci) and other streptococci (excluding enterococci, e.g.
| Sep 27, 1996 | Supplement 42Efficacy (new indication or use) · Standard review | Approved | None posted |
| Mar 11, 1981 | Original applicationNew molecular entity · Priority review | Approved | None posted |
| ClaforanEQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · injectable;injection | Cefotaxime Sodium | DiscontinuedReference drug |
| ClaforanEQ 1GM BASE/VIAL · injectable;injection | Cefotaxime Sodium | RxReference drug |
| ClaforanEQ 2GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · injectable;injection | Cefotaxime Sodium | DiscontinuedReference drug |
| ClaforanEQ 10GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · injectable;injection | Cefotaxime Sodium | DiscontinuedReference drug |
| Sep 23, 2026 | Supplement 72Labeling · Standard review | Approved | |
| Mar 23, 2015 | Supplement 71Labeling · Standard review | Approved | |
| Feb 21, 2014 | Supplement 70Labeling · Standard review | Approved | |
| Sep 9, 2011 | Supplement 68Labeling · Standard review | Approved | |
| May 27, 2009 | Supplement 67Labeling · Standard review | Approved | |
| Feb 21, 2008 | Supplement 66Labeling · Standard review | Approved | |
| Sep 2, 2004 | Supplement 61Labeling · Standard review | Approved | |
| Jun 23, 2004 | Supplement 60Labeling · Standard review | Approved | |
| Feb 22, 2002 | Supplement 57Manufacturing · Priority review | Approved | None posted |
| Jan 18, 2002 | Supplement 47Labeling · Standard review | Approved | |
| Sep 6, 2001 | Supplement 56Manufacturing · Priority review | Approved | None posted |
| Jul 27, 2001 | Supplement 55Manufacturing · Priority review | Approved | None posted |
| Apr 12, 2001 | Supplement 54Manufacturing · Priority review | Approved | None posted |
| Apr 10, 2001 | Supplement 53Manufacturing · Priority review | Approved | None posted |
| Feb 18, 2000 | Supplement 52Manufacturing · Priority review | Approved | None posted |
| Jun 26, 1998 | Supplement 50Manufacturing · Priority review | Approved | None posted |
| Jun 16, 1998 | Supplement 51Manufacturing · Priority review | Approved | None posted |
| Mar 16, 1998 | Supplement 48Manufacturing · Priority review | Approved | None posted |
| Oct 28, 1997 | Supplement 49Manufacturing · Priority review | Approved | None posted |
| Apr 24, 1997 | Supplement 45Labeling · Standard review | Approved | None posted |
| Dec 23, 1996 | Supplement 44Labeling · Standard review | Approved | None posted |
| Sep 27, 1996 | Supplement 42Efficacy (new indication or use) · Standard review | Approved | None posted |
| Sep 24, 1996 | Supplement 15Labeling | Approved | None posted |
| Apr 30, 1996 | Supplement 38Labeling · Standard review | Approved | None posted |
| Aug 25, 1995 | Supplement 40Manufacturing · Priority review | Approved | None posted |
| Aug 17, 1995 | Supplement 20Manufacturing · Priority review | Approved | None posted |
| Nov 22, 1994 | Supplement 21Labeling · Standard review | Approved | None posted |
| Sep 14, 1994 | Supplement 24Labeling · Standard review | Approved | None posted |
| Sep 2, 1994 | Supplement 25Labeling · Standard review | Approved | None posted |
| May 19, 1994 | Supplement 18Manufacturing · Priority review | Approved | None posted |
| Nov 12, 1993 | Supplement 23Manufacturing · Priority review | Approved | None posted |
| Oct 20, 1993 | Supplement 26Manufacturing · Priority review | Approved | None posted |
| Jan 19, 1993 | Supplement 22Manufacturing · Priority review | Approved | None posted |
| Jun 30, 1992 | Supplement 19Manufacturing · Priority review | Approved | None posted |
| Aug 7, 1989 | Supplement 14Labeling | Approved | None posted |
| Jun 20, 1988 | Supplement 13Manufacturing · Priority review | Approved | None posted |
| Jul 14, 1987 | Supplement 11Labeling | Approved | None posted |
| Oct 25, 1985 | Supplement 10Manufacturing · Priority review | Approved | None posted |
| Sep 16, 1985 | Supplement 8Manufacturing · Priority review | Approved | None posted |
| Jun 24, 1985 | Supplement 9Manufacturing · Priority review | Approved | None posted |
| Dec 14, 1984 | Supplement 7Manufacturing · Priority review | Approved | None posted |
| Feb 29, 1984 | Supplement 5Labeling | Approved | None posted |
| Dec 29, 1983 | Supplement 3Manufacturing · Priority review | Approved | None posted |
| Aug 23, 1983 | Supplement 4Manufacturing · Priority review | Approved | None posted |
| Jan 14, 1983 | Supplement 1Manufacturing · Priority review | Approved | None posted |
| Jul 26, 1982 | Supplement 34Labeling | Approved | None posted |
| Jun 29, 1982 | Supplement 35Labeling | Approved | None posted |
| Feb 23, 1982 | Supplement 33Labeling | Approved | None posted |
| Feb 5, 1982 | Supplement 31Manufacturing · Priority review | Approved | None posted |
| Oct 19, 1981 | Supplement 30Labeling | Approved | None posted |
| Oct 5, 1981 | Supplement 29Labeling | Approved | None posted |
| Aug 13, 1981 | Supplement 12Manufacturing · Priority review | Approved | None posted |
| Jul 22, 1981 | Supplement 28Manufacturing · Priority review | Approved | None posted |
| Mar 11, 1981 | Original applicationNew molecular entity · Priority review | Approved | None posted |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
