Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 050792
Company: B BRAUN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CEFOTAXIME AND DEXTROSE 2.4% IN PLASTIC CONTAINER CEFOTAXIME SODIUM EQ 2GM BASE INJECTABLE;INJECTION Discontinued None No No
CEFOTAXIME AND DEXTROSE 3.9% IN PLASTIC CONTAINER CEFOTAXIME SODIUM EQ 1GM BASE 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
07/29/2004 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50792lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50792ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/050792s000_Duplex_ContainerTOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/10/2007 SUPPL-2 Labeling Label (PDF)
Letter (PDF)
Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050792s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050792s002ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
09/10/2007 SUPPL-2 Labeling Label (PDF) Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050792s002lbl.pdf
07/29/2004 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50792lbl.pdf

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