Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 206829
Company: CUBIST PHARMS LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ZERBAXA CEFTOLOZANE SULFATE; TAZOBACTAM SODIUM EQ 1GM BASE/VIAL;EQ 0.5GM BASE/VIAL POWDER;INTRAVENOUS 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
12/19/2014 ORIG-1 Approval Type 1 - New Molecular Entity and Type 4 - New Combination PRIORITY Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206829lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/206829Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/206829Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/206829Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/17/2016 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

10/26/2016 SUPPL-3 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/2016/206829s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206829Orig1s003ltr.pdf
09/06/2016 SUPPL-2 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206829s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206829Orig1s002ltr.pdf
05/20/2015 SUPPL-1 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206829s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206829Orig1s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
10/26/2016 SUPPL-3 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/2016/206829s003lbl.pdf
09/06/2016 SUPPL-2 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206829s002lbl.pdf
05/20/2015 SUPPL-1 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206829s001lbl.pdf
12/19/2014 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206829lbl.pdf

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