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CEFEPIME IN PLASTIC CONTAINER از شرکت BAXTER HLTHCARE

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CEFEPIME IN PLASTIC CONTAINER از شرکت BAXTER HLTHCARE

New Drug Application (NDA): 050817

Company: BAXTER HLTHCARE

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
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

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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