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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 050821
Company: B BRAUN

Summary Review

Products on NDA 050821

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CEFEPIME AND DEXTROSE IN DUPLEX CONTAINER	CEFEPIME HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE;INJECTION	Prescription	None	No	No
CEFEPIME AND DEXTROSE IN DUPLEX CONTAINER	CEFEPIME HYDROCHLORIDE	EQ 2GM BASE/VIAL	INJECTABLE;INJECTION	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 050821

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/06/2010	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050821s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050821s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/050821_cefepime_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/050821s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/18/2022	SUPPL-6	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/050821s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/050821Orig1s006ltr.pdf
11/09/2015	SUPPL-4	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/2015/050821s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050821Orig1s004ltr.pdf
06/06/2014	SUPPL-2	Labeling-Package Insert, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050821s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050821Orig1s002ltr.pdf
09/06/2012	SUPPL-1	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050821s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050821Orig1s001ltr.pdf

Labels for NDA 050821

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/18/2022	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/050821s006lbl.pdf
11/09/2015	SUPPL-4	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/2015/050821s004lbl.pdf
06/06/2014	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050821s002lbl.pdf
06/06/2014	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050821s002lbl.pdf
09/06/2012	SUPPL-1	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050821s001lbl.pdf
05/06/2010	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050821s000lbl.pdf

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