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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 050817
Company: BAXTER HLTHCARE

Other Important Information from FDA

Summary Review

Products on NDA 050817

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CEFEPIME IN PLASTIC CONTAINER	CEFEPIME HYDROCHLORIDE	EQ 1GM BASE/50ML (EQ 20MG BASE/ML)	INJECTABLE;INJECTION	Prescription	None	Yes	Yes
CEFEPIME IN PLASTIC CONTAINER	CEFEPIME HYDROCHLORIDE	EQ 2GM BASE/100ML (EQ 20MG BASE/ML)	INJECTABLE;INJECTION	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 050817

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/05/2008	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Letter (PDF) Review Summary Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050817s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/050817_cefepime_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/050817s000_SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/01/2020	SUPPL-8	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/050817s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/050817Orig1s008ltr.pdf
05/09/2016	SUPPL-7	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/2016/050817s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/050817Orig1s007ltr.pdf
09/06/2012	SUPPL-4	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050817s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050817Orig1s004ltr.pdf
06/04/2014	SUPPL-3	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050817s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050817Orig1s003ltr.pdf
06/30/2010	SUPPL-1	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050817s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050817s001ltr.pdf

Labels for NDA 050817

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/01/2020	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/050817s008lbl.pdf
05/09/2016	SUPPL-7	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/2016/050817s007lbl.pdf
06/04/2014	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050817s003lbl.pdf
09/06/2012	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050817s004lbl.pdf
06/30/2010	SUPPL-1	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050817s001lbl.pdf

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