Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 062659
Company: SANOFI AVENTIS US
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CLAFORAN CEFOTAXIME SODIUM EQ 1GM BASE/VIAL INJECTABLE;INJECTION Discontinued None No No
CLAFORAN CEFOTAXIME SODIUM EQ 2GM BASE/VIAL INJECTABLE;INJECTION Discontinued None No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
01/13/1987 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/28/2010 SUPPL-42 Labeling

Label is not available on this site.

11/02/2015 SUPPL-41 Labeling

Label is not available on this site.

10/31/2008 SUPPL-40 Labeling

Label is not available on this site.

11/01/2005 SUPPL-35 Labeling

Label is not available on this site.

11/01/2005 SUPPL-34 Labeling

Label is not available on this site.

06/18/2002 SUPPL-31 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/01/2001 SUPPL-30 Manufacturing (CMC)-Control

Label is not available on this site.

08/13/2001 SUPPL-29 Manufacturing (CMC)-Facility

Label is not available on this site.

03/19/2001 SUPPL-28 Manufacturing (CMC)-Facility

Label is not available on this site.

02/07/2001 SUPPL-27 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

05/08/2000 SUPPL-26 Manufacturing (CMC)-Control

Label is not available on this site.

07/09/1998 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

03/17/1998 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

03/17/1998 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

08/10/1998 SUPPL-20 Labeling

Label is not available on this site.

12/20/1995 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

12/20/1995 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

07/31/1996 SUPPL-15 Labeling

Label is not available on this site.

07/14/1994 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

01/14/1994 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

07/31/1996 SUPPL-12 Labeling

Label is not available on this site.

07/31/1996 SUPPL-11 Labeling

Label is not available on this site.

07/31/1996 SUPPL-9 Labeling

Label is not available on this site.

11/09/1992 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

11/09/1992 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

12/17/1992 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

07/17/1992 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

08/30/1995 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

08/07/1989 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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