Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021572
Company: CUBIST PHARMS LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CUBICIN DAPTOMYCIN 250MG/VIAL POWDER;INTRAVENOUS Discontinued None No No
CUBICIN DAPTOMYCIN 500MG/VIAL POWDER;INTRAVENOUS Prescription AP Yes Yes
CUBICIN RF DAPTOMYCIN 500MG/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
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
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-Patient Package Insert, Labeling-Container/Carton Labels 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)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021572s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021572s008LTR.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
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-Patient Package Insert Label (PDF) Label for CUBICIN RF https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021572s058lbl.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-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

CUBICIN

POWDER;INTRAVENOUS; 500MG/VIAL
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CUBICIN DAPTOMYCIN 500MG/VIAL POWDER;INTRAVENOUS Prescription Yes AP 021572 CUBIST PHARMS LLC
DAPTOMYCIN DAPTOMYCIN 500MG/VIAL POWDER;INTRAVENOUS Prescription No AP 211961 ACCORD HLTHCARE
DAPTOMYCIN DAPTOMYCIN 500MG/VIAL POWDER;INTRAVENOUS Prescription No AP 212513 BE PHARMS
DAPTOMYCIN DAPTOMYCIN 500MG/VIAL POWDER;INTRAVENOUS Prescription No AP 208375 DR REDDYS
DAPTOMYCIN DAPTOMYCIN 500MG/VIAL POWDER;INTRAVENOUS Prescription No AP 206077 FRESENIUS KABI USA
DAPTOMYCIN DAPTOMYCIN 500MG/VIAL POWDER;INTRAVENOUS Prescription No AP 202857 HOSPIRA INC
DAPTOMYCIN DAPTOMYCIN 500MG/VIAL POWDER;INTRAVENOUS Prescription No AP 212022 JIANGSU HENGRUI MED
DAPTOMYCIN DAPTOMYCIN 500MG/VIAL POWDER;INTRAVENOUS Prescription No AP 205037 MYLAN LABS LTD
DAPTOMYCIN DAPTOMYCIN 500MG/VIAL POWDER;INTRAVENOUS Prescription No AP 207104 SAGENT PHARMS INC
DAPTOMYCIN DAPTOMYCIN 500MG/VIAL POWDER;INTRAVENOUS Prescription No AP 091039 TEVA PHARMS USA
DAPTOMYCIN DAPTOMYCIN 500MG/VIAL POWDER;INTRAVENOUS Prescription No AP 206005 XELLIA PHARMS APS

CUBICIN RF

There are no Therapeutic Equivalents.

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