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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 207131
Company: BAXTER HLTHCARE CORP

Summary Review

Products on NDA 207131

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CEFAZOLIN IN DEXTROSE	CEFAZOLIN SODIUM	EQ 2GM BASE/100ML (EQ 20MG BASE/ML)	SOLUTION;INTRAVENOUS	Prescription	None	Yes	Yes
CEFAZOLIN IN DEXTROSE	CEFAZOLIN SODIUM	EQ 1GM BASE/50ML (EQ 20MG BASE/ML)	SOLUTION;INTRAVENOUS	Prescription	None	Yes	Yes
CEFAZOLIN IN DEXTROSE	CEFAZOLIN SODIUM	EQ 3GM BASE/150ML (EQ 20MG BASE/ML)	SOLUTION;INTRAVENOUS	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 207131

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/07/2015	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/2015/207131s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/207131Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/207131Orig1s000TOC.html https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/207131Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/31/2024	SUPPL-10	Efficacy-New Dosing Regimen	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/207131s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/207131Orig1s010ltr.pdf
02/01/2024	SUPPL-9	Efficacy-New Patient Population	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/207131s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/207131Orig1s009ltr.pdf
09/20/2021	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/207131s008lbl.pdf
02/01/2021	SUPPL-6	Efficacy-New Dosing Regimen	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/207131s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/207131Orig1s006ltr.pdf
10/11/2016	SUPPL-3	Labeling-Package Insert, Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207131s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/207131Orig1s003ltr.pdf
08/01/2016	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
05/25/2016	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 207131

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/31/2024	SUPPL-10	Efficacy-New Dosing Regimen	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/207131s010lbl.pdf
02/01/2024	SUPPL-9	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/207131s009lbl.pdf
09/20/2021	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/207131s008lbl.pdf
02/01/2021	SUPPL-6	Efficacy-New Dosing Regimen	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/207131s006lbl.pdf
10/11/2016	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207131s003lbl.pdf
10/11/2016	SUPPL-3	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207131s003lbl.pdf
08/07/2015	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/207131s000lbl.pdf

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