Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 050796
Company: B BRAUN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINER CEFTRIAXONE SODIUM EQ 1GM BASE/VIAL INJECTABLE;INJECTION Prescription AP Yes Yes
CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINER CEFTRIAXONE SODIUM EQ 2GM BASE/VIAL INJECTABLE;INJECTION Prescription AP Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
04/20/2005 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/050796lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/050796ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/050796s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/09/2015 SUPPL-19 Labeling-Package Insert 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/2015/050796Orig1s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050796Orig1s019ltr.pdf
02/07/2014 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

04/10/2013 SUPPL-17 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050796s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050796Orig1s017ltr.pdf
03/11/2013 SUPPL-14 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050796s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050796Origs014ltr.pdf
06/25/2010 SUPPL-12 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050796s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050796s012ltr.pdf
01/13/2012 SUPPL-11 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050796Orig1s011lbledt.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050796s011ltr(2).pdf
05/08/2008 SUPPL-8 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050796s007,050796s008ltr.pdf
05/08/2008 SUPPL-7 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050796s007,050796s008ltr.pdf
09/10/2007 SUPPL-4 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050796s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050796s004ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
07/09/2015 SUPPL-19 Labeling-Package Insert 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/2015/050796Orig1s019lbl.pdf
04/10/2013 SUPPL-17 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050796s017lbl.pdf
03/11/2013 SUPPL-14 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050796s014lbl.pdf
01/13/2012 SUPPL-11 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050796Orig1s011lbledt.pdf
06/25/2010 SUPPL-12 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050796s012lbl.pdf
09/10/2007 SUPPL-4 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050796s004lbl.pdf
04/20/2005 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/050796lbl.pdf

CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINER

INJECTABLE;INJECTION; EQ 1GM BASE/VIAL
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CEFTRIAXONE CEFTRIAXONE SODIUM EQ 1GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 065329 ACS DOBFAR
CEFTRIAXONE CEFTRIAXONE SODIUM EQ 1GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 065204 SANDOZ INC
CEFTRIAXONE CEFTRIAXONE SODIUM EQ 1GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 065180 WOCKHARDT
CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINER CEFTRIAXONE SODIUM EQ 1GM BASE/VIAL INJECTABLE;INJECTION Prescription Yes AP 050796 B BRAUN

INJECTABLE;INJECTION; EQ 2GM BASE/VIAL
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CEFTRIAXONE CEFTRIAXONE SODIUM EQ 2GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 065329 ACS DOBFAR
CEFTRIAXONE CEFTRIAXONE SODIUM EQ 2GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 065204 SANDOZ INC
CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINER CEFTRIAXONE SODIUM EQ 2GM BASE/VIAL INJECTABLE;INJECTION Prescription Yes AP 050796 B BRAUN

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