Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021227
Company: MERCK
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CANCIDAS CASPOFUNGIN ACETATE 50MG/VIAL POWDER;IV (INFUSION) Prescription AP Yes Yes
CANCIDAS CASPOFUNGIN ACETATE 70MG/VIAL POWDER;IV (INFUSION) Prescription AP 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
01/26/2001 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21227_Cancidas_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21227_Cancidas_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21227_Cancidas.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/25/2017 SUPPL-37 Labeling-Package Insert, Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021227s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021227Orig1s037ltr.pdf
08/09/2017 SUPPL-36 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021227s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021227Orig1s036ltr.pdf
04/12/2016 SUPPL-35 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021227s034s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021227Orig1s034,s035ltr.pdf
04/12/2016 SUPPL-34 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021227s034s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021227Orig1s034,s035ltr.pdf
10/23/2014 SUPPL-33 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021227s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021227Orig1s033ltr.pdf
12/18/2013 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

01/08/2013 SUPPL-31 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021227s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021227Orig1s031ltr.pdf
08/02/2013 SUPPL-30 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021227s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021227Orig1s030ltr.pdf
04/30/2012 SUPPL-29 Labeling-Container/Carton Labels Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021227s029ltr.pdf
10/22/2010 SUPPL-28 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021227s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021227s028ltr.pdf
01/28/2010 SUPPL-27 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021227s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021227s027ltr.pdf
05/04/2009 SUPPL-24 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021227s024ltr.pdf
06/26/2009 SUPPL-23 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021227s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021227s023ltr.pdf
07/21/2008 SUPPL-22 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021227s022ltr.pdf
07/29/2008 SUPPL-21 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021227s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021227s021ltr.pdf
02/16/2005 SUPPL-15 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21227s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21227s015ltr.pdf
03/17/2004 SUPPL-14 Labeling Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21227slr011,014_cancidas_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21227slr011,014ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021227_S014_CANCIDAS.pdf
09/29/2004 SUPPL-12 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21227s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21227s012ltr.pdf
03/17/2004 SUPPL-11 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21227slr011,014_cancidas_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21227slr011,014ltr.pdf
12/10/2002 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

11/15/2002 SUPPL-8 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/07/2003 SUPPL-7 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021227s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21227se1-007ltr.pdf
06/12/2002 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

11/21/2002 SUPPL-5 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21227_cancidas_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21227slr005ltr.pdf
04/11/2002 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

09/20/2002 SUPPL-3 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21227s1s3lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21227se1-001,slr003ltr.pdf
09/20/2002 SUPPL-1 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21227s1s3lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21227se1-001,slr003ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
08/25/2017 SUPPL-37 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021227s037lbl.pdf
08/25/2017 SUPPL-37 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021227s037lbl.pdf
08/09/2017 SUPPL-36 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021227s036lbl.pdf
04/12/2016 SUPPL-35 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021227s034s035lbl.pdf
04/12/2016 SUPPL-34 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021227s034s035lbl.pdf
10/23/2014 SUPPL-33 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021227s033lbl.pdf
08/02/2013 SUPPL-30 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021227s030lbl.pdf
01/08/2013 SUPPL-31 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021227s031lbl.pdf
10/22/2010 SUPPL-28 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021227s028lbl.pdf
01/28/2010 SUPPL-27 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021227s027lbl.pdf
06/26/2009 SUPPL-23 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021227s023lbl.pdf
07/29/2008 SUPPL-21 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021227s021lbl.pdf
02/16/2005 SUPPL-15 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21227s015lbl.pdf
09/29/2004 SUPPL-12 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21227s012lbl.pdf
03/17/2004 SUPPL-14 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21227slr011,014_cancidas_lbl.pdf
03/17/2004 SUPPL-11 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21227slr011,014_cancidas_lbl.pdf
01/07/2003 SUPPL-7 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021227s007lbl.pdf
11/21/2002 SUPPL-5 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21227_cancidas_lbl.pdf
09/20/2002 SUPPL-3 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21227s1s3lbl.pdf
09/20/2002 SUPPL-1 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21227s1s3lbl.pdf
01/26/2001 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21227_Cancidas_prntlbl.pdf

CANCIDAS

POWDER;IV (INFUSION); 50MG/VIAL
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CANCIDAS CASPOFUNGIN ACETATE 50MG/VIAL POWDER;IV (INFUSION) Prescription Yes AP 021227 MERCK
CASPOFUNGIN ACETATE CASPOFUNGIN ACETATE 50MG/VIAL POWDER;IV (INFUSION) Prescription No AP 206110 FRESENIUS KABI USA

POWDER;IV (INFUSION); 70MG/VIAL
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CANCIDAS CASPOFUNGIN ACETATE 70MG/VIAL POWDER;IV (INFUSION) Prescription Yes AP 021227 MERCK
CASPOFUNGIN ACETATE CASPOFUNGIN ACETATE 70MG/VIAL POWDER;IV (INFUSION) Prescription No AP 206110 FRESENIUS KABI USA

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