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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 050780
Company: B BRAUN

Products on NDA 050780

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CEFUROXIME AND DEXTROSE IN DUPLEX CONTAINER	CEFUROXIME SODIUM	EQ 750MG BASE/VIAL	INJECTABLE;INJECTION	Discontinued	None	Yes	No
CEFUROXIME AND DEXTROSE IN DUPLEX CONTAINER	CEFUROXIME SODIUM	EQ 1.5GM BASE/VIAL	INJECTABLE;INJECTION	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 050780

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/21/2001	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/50780_Cefuroxime_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/50780_Cefuroxime_approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/50780_Cefuroxime.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/05/2020	SUPPL-20	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/050780s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/050780Orig1s020ltr.pdf
05/01/2015	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/2015/050780s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050780Orig1s019ltr.pdf
12/12/2013	SUPPL-18	Manufacturing (CMC)		Label is not available on this site.
09/10/2007	SUPPL-11	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050780s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050780s011ltr.pdf
05/06/2005	SUPPL-8	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/050780s008ltr.pdf
06/29/2004	SUPPL-6	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50780slr006ltr.pdf
08/18/2003	SUPPL-5	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50780slr005ltr.pdf

Labels for NDA 050780

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/05/2020	SUPPL-20	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/050780s020lbl.pdf
05/01/2015	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/2015/050780s019lbl.pdf
09/10/2007	SUPPL-11	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050780s011lbl.pdf
02/21/2001	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/50780_Cefuroxime_prntlbl.pdf

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