Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021506
Company: ASTELLAS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MYCAMINE MICAFUNGIN SODIUM 50MG INJECTABLE; INJECTION Prescription None No No
MYCAMINE MICAFUNGIN SODIUM EQ 50MG BASE/VIAL INJECTABLE;INTRAVENOUS Prescription AP Yes Yes
MYCAMINE MICAFUNGIN SODIUM EQ 100MG BASE/VIAL INJECTABLE;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
03/16/2005 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21506,21754lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21506,21754ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/21-506_Mycamine.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/26/2016 SUPPL-19 Labeling-Package Insert, 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/2016/021506s019lbl.pdf
06/06/2016 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

08/27/2015 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

06/21/2013 SUPPL-15 Efficacy-Pediatric Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021506s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021506Orig1s015ltr.pdf
04/19/2013 SUPPL-14 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021506s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021506Orig1s014ltr.pdf
06/08/2011 SUPPL-12 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021506s011s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021506s011,s012ltr.pdf
06/08/2011 SUPPL-11 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021506s011s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021506s011,s012ltr.pdf
08/06/2007 SUPPL-9 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021506s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021506s009ltr.pdf
01/22/2008 SUPPL-8 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021506s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021506s008ltr.pdf
06/27/2006 SUPPL-4 Labeling-Package Insert, Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021506s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021506s004ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
08/26/2016 SUPPL-19 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/2016/021506s019lbl.pdf
08/26/2016 SUPPL-19 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/2016/021506s019lbl.pdf
06/21/2013 SUPPL-15 Efficacy-Pediatric Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021506s015lbl.pdf
04/19/2013 SUPPL-14 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021506s014lbl.pdf
06/08/2011 SUPPL-12 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021506s011s012lbl.pdf
06/08/2011 SUPPL-11 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021506s011s012lbl.pdf
01/22/2008 SUPPL-8 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021506s008lbl.pdf
08/06/2007 SUPPL-9 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021506s009lbl.pdf
06/27/2006 SUPPL-4 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021506s004lbl.pdf
06/27/2006 SUPPL-4 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021506s004lbl.pdf
03/16/2005 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21506,21754lbl.pdf

MYCAMINE

INJECTABLE;INTRAVENOUS; EQ 50MG BASE/VIAL
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
MICAFUNGIN SODIUM MICAFUNGIN SODIUM EQ 50MG BASE/VIAL INJECTABLE;INTRAVENOUS Prescription No AP 207344 FRESENIUS KABI USA
MYCAMINE MICAFUNGIN SODIUM EQ 50MG BASE/VIAL INJECTABLE;INTRAVENOUS Prescription Yes AP 021506 ASTELLAS

INJECTABLE;INTRAVENOUS; EQ 100MG BASE/VIAL
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
MICAFUNGIN SODIUM MICAFUNGIN SODIUM EQ 100MG BASE/VIAL INJECTABLE;INTRAVENOUS Prescription No AP 207344 FRESENIUS KABI USA
MYCAMINE MICAFUNGIN SODIUM EQ 100MG BASE/VIAL INJECTABLE;INTRAVENOUS Prescription Yes AP 021506 ASTELLAS

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