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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 206829
Company: CUBIST PHARMS LLC

Summary Review

Products on NDA 206829

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 206829

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
04/21/2022	SUPPL-12	Efficacy-New Patient Population	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/206829s011s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/206829Orig1s011, s012ltr.pdf
04/21/2022	SUPPL-11	Efficacy-New Patient Population	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/206829s011s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/206829Orig1s011, s012ltr.pdf
12/13/2019	SUPPL-9	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/206829s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/206829Orig1s009ltr.pdf
06/03/2019	SUPPL-8	Efficacy-New Indication	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/206829s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/206829Orig1s008ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/206829Orig1s008.pdf
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/2015/206829Orig1s001Lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206829Orig1s001ltr.pdf

Labels for NDA 206829

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/21/2022	SUPPL-12	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/206829s011s012lbl.pdf
04/21/2022	SUPPL-11	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/206829s011s012lbl.pdf
12/13/2019	SUPPL-9	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/206829s009lbl.pdf
06/03/2019	SUPPL-8	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/206829s008lbl.pdf
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/2015/206829Orig1s001Lbl.pdf
12/19/2014	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206829lbl.pdf

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