Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 207131
Company: BAXTER HLTHCARE CORP
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CEFAZOLIN IN PLASTIC CONTAINER CEFAZOLIN SODIUM EQ 2GM BASE/100ML (EQ 20MG BASE/ML) SOLUTION;INTRAVENOUS Prescription None No No
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.cfm 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
10/11/2016 SUPPL-3 Labeling-Container/Carton Labels, Labeling-Package Insert 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.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
10/11/2016 SUPPL-3 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207131s003lbl.pdf
10/11/2016 SUPPL-3 Labeling-Package Insert 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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