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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021506
Company: ASTELLAS

Package Label

Products on NDA 021506

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021506

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
07/31/2020	SUPPL-24	Manufacturing (CMC)-Formulation	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021506Orig1s024ltr.pdf
12/20/2019	SUPPL-23	Efficacy-New Patient Population	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021506s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021506Orig1s023ltr.pdf
08/26/2016	SUPPL-19	Labeling-Container/Carton Labels, 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
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-Container/Carton Labels, Labeling-Package Insert	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

Labels for NDA 021506

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/20/2019	SUPPL-23	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021506s023lbl.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
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
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-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021506s004lbl.pdf
06/27/2006	SUPPL-4	Labeling-Package Insert	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

Therapeutic Equivalents for NDA 021506

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	208366	APOTEX
MICAFUNGIN SODIUM	MICAFUNGIN SODIUM	EQ 50MG BASE/VIAL	INJECTABLE;INTRAVENOUS	Prescription	No	AP	207344	FRESENIUS KABI USA
MICAFUNGIN SODIUM	MICAFUNGIN SODIUM	EQ 50MG BASE/VIAL	INJECTABLE;INTRAVENOUS	Prescription	No	AP	213261	HIKMA
MICAFUNGIN SODIUM	MICAFUNGIN SODIUM	EQ 50MG BASE/VIAL	INJECTABLE;INTRAVENOUS	Prescription	No	AP	213363	JIANGSU HANSOH PHARM
MICAFUNGIN SODIUM	MICAFUNGIN SODIUM	EQ 50MG BASE/VIAL	INJECTABLE;INTRAVENOUS	Prescription	No	AP	215381	MEITHEAL
MICAFUNGIN SODIUM	MICAFUNGIN SODIUM	EQ 50MG BASE/VIAL	INJECTABLE;INTRAVENOUS	Prescription	No	AP	211713	XELLIA PHARMS APS
MICAFUNGIN SODIUM	MICAFUNGIN SODIUM	EQ 50MG BASE/VIAL	INJECTABLE;INTRAVENOUS	Prescription	No	AP	215241	ZYDUS PHARMS
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	208366	APOTEX
MICAFUNGIN SODIUM	MICAFUNGIN SODIUM	EQ 100MG BASE/VIAL	INJECTABLE;INTRAVENOUS	Prescription	No	AP	207344	FRESENIUS KABI USA
MICAFUNGIN SODIUM	MICAFUNGIN SODIUM	EQ 100MG BASE/VIAL	INJECTABLE;INTRAVENOUS	Prescription	No	AP	213261	HIKMA
MICAFUNGIN SODIUM	MICAFUNGIN SODIUM	EQ 100MG BASE/VIAL	INJECTABLE;INTRAVENOUS	Prescription	No	AP	213363	JIANGSU HANSOH PHARM
MICAFUNGIN SODIUM	MICAFUNGIN SODIUM	EQ 100MG BASE/VIAL	INJECTABLE;INTRAVENOUS	Prescription	No	AP	215381	MEITHEAL
MICAFUNGIN SODIUM	MICAFUNGIN SODIUM	EQ 100MG BASE/VIAL	INJECTABLE;INTRAVENOUS	Prescription	No	AP	211713	XELLIA PHARMS APS
MICAFUNGIN SODIUM	MICAFUNGIN SODIUM	EQ 100MG BASE/VIAL	INJECTABLE;INTRAVENOUS	Prescription	No	AP	215241	ZYDUS PHARMS
MYCAMINE	MICAFUNGIN SODIUM	EQ 100MG BASE/VIAL	INJECTABLE;INTRAVENOUS	Prescription	Yes	AP	021506	ASTELLAS

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