Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021227
Company: MERCK
Company: MERCK
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CANCIDAS | CASPOFUNGIN ACETATE | 50MG/VIAL | POWDER;INTRAVENOUS | Prescription | AP | Yes | Yes |
| CANCIDAS | CASPOFUNGIN ACETATE | 70MG/VIAL | POWDER;INTRAVENOUS | 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 |
|---|---|---|---|---|---|
| 10/25/2021 | SUPPL-40 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021227Orig1s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021227Orig1s040ltr.pdf | |
| 02/08/2019 | SUPPL-39 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021227s039lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021227Orig1s039ltr.pdf | |
| 03/13/2018 | SUPPL-38 | Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021227s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021227Orig1s038ltr.pdf | |
| 08/25/2017 | SUPPL-37 | Labeling-Package Insert, Labeling-Container/Carton Labels |
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/2017/021227s037lbl.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 |
|---|---|---|---|---|---|
| 10/25/2021 | SUPPL-40 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021227Orig1s040lbl.pdf | |
| 10/25/2021 | SUPPL-40 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021227Orig1s040lbl.pdf | |
| 02/08/2019 | SUPPL-39 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021227s039lbl.pdf | |
| 03/13/2018 | SUPPL-38 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021227s038lbl.pdf | |
| 08/25/2017 | SUPPL-37 | 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/2017/021227s037lbl.pdf |
| 08/25/2017 | SUPPL-37 | Labeling-Container/Carton Labels | 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/2017/021227s037lbl.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;INTRAVENOUS; 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;INTRAVENOUS | Prescription | Yes | AP | 021227 | MERCK |
| CASPOFUNGIN ACETATE | CASPOFUNGIN ACETATE | 50MG/VIAL | POWDER;INTRAVENOUS | Prescription | No | AP | 211263 | AREVA PHARMS |
| CASPOFUNGIN ACETATE | CASPOFUNGIN ACETATE | 50MG/VIAL | POWDER;INTRAVENOUS | Prescription | No | AP | 206110 | FRESENIUS KABI USA |
| CASPOFUNGIN ACETATE | CASPOFUNGIN ACETATE | 50MG/VIAL | POWDER;INTRAVENOUS | Prescription | No | AP | 207092 | GLAND |
| CASPOFUNGIN ACETATE | CASPOFUNGIN ACETATE | 50MG/VIAL | POWDER;INTRAVENOUS | Prescription | No | AP | 200833 | HENGRUI PHARMA |
POWDER;INTRAVENOUS; 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;INTRAVENOUS | Prescription | Yes | AP | 021227 | MERCK |
| CASPOFUNGIN ACETATE | CASPOFUNGIN ACETATE | 70MG/VIAL | POWDER;INTRAVENOUS | Prescription | No | AP | 211263 | AREVA PHARMS |
| CASPOFUNGIN ACETATE | CASPOFUNGIN ACETATE | 70MG/VIAL | POWDER;INTRAVENOUS | Prescription | No | AP | 206110 | FRESENIUS KABI USA |
| CASPOFUNGIN ACETATE | CASPOFUNGIN ACETATE | 70MG/VIAL | POWDER;INTRAVENOUS | Prescription | No | AP | 207092 | GLAND |
| CASPOFUNGIN ACETATE | CASPOFUNGIN ACETATE | 70MG/VIAL | POWDER;INTRAVENOUS | Prescription | No | AP | 200833 | HENGRUI PHARMA |