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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 205435
Company: CUBIST PHARMS LLC

Summary Review

Products on NDA 205435

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SIVEXTRO	TEDIZOLID PHOSPHATE	200MG	TABLET;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 205435

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/20/2014	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205435s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205435Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205435Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205435Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/17/2021	SUPPL-14	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/205435s014,205435s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/205435Orig1s014, 205436Orig1s009ltr.pdf
10/22/2020	SUPPL-13	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/205435s013,205436s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/205435Orig1s013,205436Orig1s008ltr.pdf
06/19/2020	SUPPL-12	Efficacy-New Patient Population	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/205435s012,205436s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/205435Orig1s012; 205436Orig1s007ltr.pdf
09/09/2019	SUPPL-11	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/205435s011,205436s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/205435Orig1s011, 205436Orig1s006ltr.pdf
03/06/2019	SUPPL-10	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/205435s010,205436s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/205435Orig1s010, 205436Orig1s005ltr.pdf
08/12/2017	SUPPL-8	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/2017/205435s008,205436s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205435Orig1s008,205436Orig1s004ltr.pdf
08/12/2017	SUPPL-7	Labeling-Patient Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205435s007,205436s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205435Orig1s007,205436Orig1s003ltr.pdf
09/16/2016	SUPPL-6	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205435s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205435Orig1s006ltr.pdf
06/05/2016	SUPPL-5	Labeling-Container/Carton Labels	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205435Orig1s005ltr.pdf
11/01/2016	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
10/28/2016	SUPPL-3	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205435s003,205436s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205435Orig1s003,205436Orig1s002ltr.pdf
08/11/2015	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
03/04/2015	SUPPL-1	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/0205435s001,0205436s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205435Orig1s001,205436Orig1s001ltr.pdf

Labels for NDA 205435

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/17/2021	SUPPL-14	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/205435s014,205435s009lbl.pdf
10/22/2020	SUPPL-13	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/205435s013,205436s008lbl.pdf
06/19/2020	SUPPL-12	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/205435s012,205436s007lbl.pdf
09/09/2019	SUPPL-11	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/205435s011,205436s006lbl.pdf
03/06/2019	SUPPL-10	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/205435s010,205436s005lbl.pdf
08/12/2017	SUPPL-8	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/2017/205435s008,205436s004lbl.pdf
08/12/2017	SUPPL-7	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205435s007,205436s003lbl.pdf
10/28/2016	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205435s003,205436s002lbl.pdf
09/16/2016	SUPPL-6	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205435s006lbl.pdf
03/04/2015	SUPPL-1	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/0205435s001,0205436s001lbl.pdf
06/20/2014	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205435s000lbl.pdf

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