Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021572
Company: CUBIST PHARMS LLC
Company: CUBIST PHARMS LLC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CUBICIN | DAPTOMYCIN | 250MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | POWDER;INTRAVENOUS | Discontinued | None | No | No |
| CUBICIN | DAPTOMYCIN | 500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | POWDER;INTRAVENOUS | Discontinued | None | Yes | No |
| CUBICIN RF | DAPTOMYCIN | 500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | POWDER;INTRAVENOUS | Discontinued | None | Yes | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 09/12/2003 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21572_cubicin_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21572ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-572_Cubicin.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 02/23/2022 | SUPPL-68 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021572s068lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/021572Orig1s068ltr.pdf | |
| 10/26/2021 | SUPPL-66 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021572s065s066lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021572Orig1s065,s066ltr.pdf | |
| 10/26/2021 | SUPPL-65 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021572s065s066lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021572Orig1s065,s066ltr.pdf | |
| 08/26/2020 | SUPPL-64 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021572s063,064lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021572Orig1s063, s064ltr.pdf | |
| 08/26/2020 | SUPPL-63 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021572s063,064lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021572Orig1s063, s064ltr.pdf | |
| 12/03/2018 | SUPPL-61 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021572s061lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021572s061ltr.pdf | |
| 09/01/2017 | SUPPL-60 | Labeling-Package Insert |
Label (PDF)
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/2017/021572s060lblcubicinRF.pdf https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021572s060lblcubicin.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021572Orig1s060ltr.pdf |
| 06/09/2017 | SUPPL-59 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021572s059lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021572Orig1s059ltr.pdf | |
| 03/29/2017 | SUPPL-58 | Labeling-Container/Carton Labels, Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
Label for CUBICIN RF | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021572s058lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021572Orig1s058ltr.pdf |
| 09/01/2017 | SUPPL-57 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021572s057lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021572Orig1s057ltr.pdf | |
| 03/29/2017 | SUPPL-55 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
Label for CUBICIN | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021572s055lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021572Orig1s055ltr.pdf |
| 07/07/2016 | SUPPL-53 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021572s053lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021572Orig1s053ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/021572Orig1s053.pdf | |
| 07/06/2016 | SUPPL-52 | Labeling |
Label (PDF)
Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021572s052lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/021572Orig1s052.pdf | |
| 03/15/2016 | SUPPL-51 | Labeling-Package Insert, Labeling-Proprietary Name Change |
Label is not available on this site. |
||
| 09/17/2015 | SUPPL-50 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021572s050lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021572Orig1s050ltr.pdf | |
| 07/15/2015 | SUPPL-49 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/03/2015 | SUPPL-48 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021572Orig1s048lbledt.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021572Orig1s048ltr.pdf | |
| 02/16/2015 | SUPPL-47 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/26/2014 | SUPPL-46 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021572s046lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021572Orig1s046ltr.pdf | |
| 09/26/2014 | SUPPL-45 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/22/2013 | SUPPL-44 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021572s043s044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021572Orig1s043,021572Orig1s044ltr.pdf | |
| 11/22/2013 | SUPPL-43 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021572s043s044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021572Orig1s043,021572Orig1s044ltr.pdf | |
| 06/26/2013 | SUPPL-42 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/19/2013 | SUPPL-41 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/11/2012 | SUPPL-40 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021572s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021572Orig1s040ltr.pdf | |
| 06/14/2012 | SUPPL-39 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021572s039lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021572s039ltr.pdf | |
| 10/03/2011 | SUPPL-38 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021572s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021572s038ltr.pdf | |
| 05/22/2012 | SUPPL-37 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021572s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021572s037ltr.pdf | |
| 12/14/2010 | SUPPL-34 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/13/2010 | SUPPL-33 | Labeling |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021572s033lbl.pdf | |
| 11/30/2010 | SUPPL-32 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021572s022s023s024s027s030s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021572s022,s023,s024,s027,s030,s032ltr.pdf | |
| 12/06/2010 | SUPPL-31 | Labeling-Package Insert |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021572s031ltr.pdf |
| 11/30/2010 | SUPPL-30 | Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021572s022s023s024s027s030s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021572s022,s023,s024,s027,s030,s032ltr.pdf | |
| 11/30/2010 | SUPPL-27 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021572s022s023s024s027s030s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021572s022,s023,s024,s027,s030,s032ltr.pdf | |
| 11/30/2010 | SUPPL-24 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021572s022s023s024s027s030s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021572s022,s023,s024,s027,s030,s032ltr.pdf | |
| 11/30/2010 | SUPPL-23 | Efficacy-New Dosing Regimen |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021572s022s023s024s027s030s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021572s022,s023,s024,s027,s030,s032ltr.pdf | |
| 11/30/2010 | SUPPL-22 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021572s022s023s024s027s030s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021572s022,s023,s024,s027,s030,s032ltr.pdf | |
| 02/10/2009 | SUPPL-21 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021572s021ltr.pdf |
| 10/05/2007 | SUPPL-14 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021572s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021572s014ltr.pdf | |
| 02/20/2007 | SUPPL-11 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021572s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021572s011ltr.pdf | |
| 02/12/2007 | SUPPL-10 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021572s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021572s010ltr.pdf | |
| 10/24/2006 | SUPPL-9 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021572s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021572s009ltr.pdf | |
| 05/25/2006 | SUPPL-8 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021572s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021572s008LTR.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/021572Orig1s008.pdf | |
| 03/08/2006 | SUPPL-7 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021572s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021572s007ltr.pdf | |
| 10/14/2005 | SUPPL-6 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021572s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021572s006ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 02/23/2022 | SUPPL-68 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021572s068lbl.pdf | |
| 10/26/2021 | SUPPL-66 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021572s065s066lbl.pdf | |
| 10/26/2021 | SUPPL-65 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021572s065s066lbl.pdf | |
| 08/26/2020 | SUPPL-64 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021572s063,064lbl.pdf | |
| 08/26/2020 | SUPPL-63 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021572s063,064lbl.pdf | |
| 12/03/2018 | SUPPL-61 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021572s061lbl.pdf | |
| 09/01/2017 | SUPPL-60 | 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/2017/021572s060lblcubicinRF.pdf |
| 09/01/2017 | SUPPL-60 | 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/2017/021572s060lblcubicin.pdf |
| 09/01/2017 | SUPPL-57 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021572s057lbl.pdf | |
| 06/09/2017 | SUPPL-59 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021572s059lbl.pdf | |
| 03/29/2017 | SUPPL-58 | Labeling-Container/Carton Labels | Label (PDF) | Label for CUBICIN RF | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021572s058lbl.pdf |
| 03/29/2017 | SUPPL-58 | Labeling-Patient Package Insert | Label (PDF) | Label for CUBICIN RF | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021572s058lbl.pdf |
| 03/29/2017 | SUPPL-55 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | Label for CUBICIN | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021572s055lbl.pdf |
| 07/07/2016 | SUPPL-53 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021572s053lbl.pdf | |
| 07/06/2016 | SUPPL-52 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021572s052lbl.pdf | |
| 09/17/2015 | SUPPL-50 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021572s050lbl.pdf | |
| 08/03/2015 | SUPPL-48 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021572Orig1s048lbledt.pdf | |
| 11/26/2014 | SUPPL-46 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021572s046lbl.pdf | |
| 11/22/2013 | SUPPL-44 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021572s043s044lbl.pdf | |
| 11/22/2013 | SUPPL-43 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021572s043s044lbl.pdf | |
| 10/11/2012 | SUPPL-40 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021572s040lbl.pdf | |
| 06/14/2012 | SUPPL-39 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021572s039lbl.pdf | |
| 05/22/2012 | SUPPL-37 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021572s037lbl.pdf | |
| 10/03/2011 | SUPPL-38 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021572s038lbl.pdf | |
| 11/30/2010 | SUPPL-32 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021572s022s023s024s027s030s032lbl.pdf | |
| 11/30/2010 | SUPPL-30 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021572s022s023s024s027s030s032lbl.pdf | |
| 11/30/2010 | SUPPL-27 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021572s022s023s024s027s030s032lbl.pdf | |
| 11/30/2010 | SUPPL-24 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021572s022s023s024s027s030s032lbl.pdf | |
| 11/30/2010 | SUPPL-23 | Efficacy-New Dosing Regimen | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021572s022s023s024s027s030s032lbl.pdf | |
| 11/30/2010 | SUPPL-22 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021572s022s023s024s027s030s032lbl.pdf | |
| 08/13/2010 | SUPPL-33 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021572s033lbl.pdf | |
| 10/05/2007 | SUPPL-14 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021572s014lbl.pdf | |
| 02/20/2007 | SUPPL-11 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021572s011lbl.pdf | |
| 02/12/2007 | SUPPL-10 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021572s010lbl.pdf | |
| 10/24/2006 | SUPPL-9 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021572s009lbl.pdf | |
| 05/25/2006 | SUPPL-8 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021572s008lbl.pdf | |
| 03/08/2006 | SUPPL-7 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021572s007lbl.pdf | |
| 10/14/2005 | SUPPL-6 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021572s006lbl.pdf | |
| 09/12/2003 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21572_cubicin_lbl.pdf |