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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 050792
Company: B BRAUN

Products on NDA 050792

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 050792

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

Labels for NDA 050792

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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