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CUBICIN از شرکت CUBIST PHARMS LLC

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CUBICIN از شرکت CUBIST PHARMS LLC

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
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/2017/021572s060lblcubicin.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021572s060lblcubicinRF.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
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-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 212250 HISUN PHARM HANGZHOU
DAPTOMYCIN DAPTOMYCIN 500MG/VIAL POWDER;INTRAVENOUS Prescription No AP 213623 HONG KONG
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.

بخوانید  CHLORPROMAZINE HYDROCHLORIDE از شرکت AUROBINDO PHARMA LTD
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