Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 205435
Company: CUBIST PHARMS LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SIVEXTRO TEDIZOLID PHOSPHATE 200MG TABLET;ORAL 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
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
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
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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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