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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 050796
Company: B BRAUN

Products on NDA 050796

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 050796

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
01/13/2022	SUPPL-30	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/050796s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/050796Orig1s030ltr.pdf
03/09/2021	SUPPL-25	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/050796s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/050796Orig1s025ltr.pdf
09/09/2020	SUPPL-23	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/050796s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/050796Orig1s023ltr.pdf
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

Labels for NDA 050796

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/13/2022	SUPPL-30	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/050796s030lbl.pdf
03/09/2021	SUPPL-25	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/050796s025lbl.pdf
09/09/2020	SUPPL-23	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/050796s023lbl.pdf
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

Therapeutic Equivalents for NDA 050796

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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