Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 205436
Company: CUBIST PHARMS LLC
Company: CUBIST PHARMS LLC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
SIVEXTRO | TEDIZOLID PHOSPHATE | 200MG/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 |
---|---|---|---|---|---|---|---|
06/20/2014 | ORIG-1 | Approval | Type 3 - New Dosage Form | PRIORITY |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205436s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205436Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205436Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205436Orig1s000SumR.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
11/17/2021 | SUPPL-9 | Labeling-Patient Package Insert, 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-8 | 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-7 | 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-6 | 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,%20205436Orig1s006ltr.pdf | |
03/06/2019 | SUPPL-5 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/205436s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/205435Orig1s010,%20205436Orig1s005ltr.pdf | |
08/12/2017 | SUPPL-4 | 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-3 | 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 | |
10/28/2016 | SUPPL-2 | 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 | |
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 |
---|---|---|---|---|---|
11/17/2021 | SUPPL-9 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/205435s014,205435s009lbl.pdf | |
11/17/2021 | SUPPL-9 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/205435s014,205435s009lbl.pdf | |
10/22/2020 | SUPPL-8 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/205435s013,205436s008lbl.pdf | |
06/19/2020 | SUPPL-7 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/205435s012,205436s007lbl.pdf | |
09/09/2019 | SUPPL-6 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/205435s011,205436s006lbl.pdf | |
03/06/2019 | SUPPL-5 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/205436s005lbl.pdf | |
08/12/2017 | SUPPL-4 | 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-3 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205435s007,205436s003lbl.pdf | |
10/28/2016 | SUPPL-2 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205435s003,205436s002lbl.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/2014/205436s000lbl.pdf |