An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

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.html 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
07/29/2025	SUPPL-12	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/050817s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/050817Orig1s012ltr.pdf
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
07/29/2025	SUPPL-12	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/050817s012lbl.pdf
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

Top