Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 064201
Company: FRESENIUS KABI USA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CEFOTAXIME CEFOTAXIME SODIUM EQ 10GM BASE/VIAL INJECTABLE;INJECTION Discontinued None No No
CEFOTAXIME CEFOTAXIME SODIUM EQ 20GM 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
03/24/2000 ORIG-1 Approval Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/64201ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/064201.PDF
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/30/2008 SUPPL-11 Labeling

Label is not available on this site.

09/21/2005 SUPPL-10 Labeling

Label is not available on this site.

03/17/2004 SUPPL-8 Labeling

Label is not available on this site.

06/16/2004 SUPPL-7 Labeling

Label is not available on this site.

08/13/2002 SUPPL-6 Manufacturing (CMC)-Formulation

Label is not available on this site.

03/28/2002 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

01/04/2002 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

06/28/2001 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

06/28/2001 SUPPL-1 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

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