FDA.reportPublic FDA data

Application 021506

Type
NDA
Sponsor
ASTELLAS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MYCAMINEMICAFUNGIN SODIUMINJECTABLE; INJECTION50MGNoNo
002MYCAMINEMICAFUNGIN SODIUMINJECTABLE;INTRAVENOUSEQ 50MG BASE/VIALYesYes
003MYCAMINEMICAFUNGIN SODIUMINJECTABLE;INTRAVENOUSEQ 100MG BASE/VIALYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0469-3211MycamineMicafungin sodiumAstellas Pharma US, Inc.NDACurrent
0469-3211MycamineMicafungin SodiumAstellas Pharma US, Inc.NDACurrent
0469-3211MycamineMicafungin sodiumAstellas Pharma US, Inc.NDACurrent
0469-3211MycamineMicafungin SodiumAstellas Pharma US, Inc.NDACurrent
0469-3211MycamineMicafungin SodiumAstellas Pharma US, Inc.NDACurrent
0469-3211MycamineMicafungin sodiumAstellas Pharma US, Inc.NDACurrent
0469-3211MycamineMicafungin sodiumAstellas Pharma US, Inc.NDACurrent
0469-3211MycamineMicafungin SodiumAstellas Pharma US, Inc.NDACurrent
0469-3211MycamineMicafungin sodiumAstellas Pharma US, Inc.NDACurrent
0469-3211MycamineMicafungin SodiumAstellas Pharma US, Inc.NDACurrent
0469-3211MycamineMicafungin SodiumAstellas Pharma US, Inc.NDACurrent
0469-3250MycamineMicafungin SodiumAstellas Pharma US, Inc.NDACurrent
0469-3250MycamineMicafungin sodiumAstellas Pharma US, Inc.NDACurrent
0469-3250MycamineMicafungin sodiumAstellas Pharma US, Inc.NDACurrent
0469-3250MycamineMicafungin sodiumAstellas Pharma US, Inc.NDACurrent
0469-3250MycamineMicafungin sodiumAstellas Pharma US, Inc.NDACurrent
0469-3250MycamineMicafungin SodiumAstellas Pharma US, Inc.NDACurrent
0469-3250MycamineMicafungin sodiumAstellas Pharma US, Inc.NDACurrent
0469-3250MycamineMicafungin SodiumAstellas Pharma US, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
65888SUPPL2021-01-12
61451SUPPL2019-12-26
61416SUPPL2019-12-23
45175SUPPL2016-08-26
15631SUPPL2013-06-25
5577SUPPL2013-06-24
27965SUPPL2013-04-24
37097SUPPL2013-04-23
37096SUPPL2011-06-27
15630SUPPL2011-06-27
5576SUPPL2011-06-10
5575SUPPL2011-06-10
27964SUPPL2008-01-24
15629SUPPL2008-01-24
37095SUPPL2007-08-07
5574SUPPL2007-08-07
27963SUPPL2006-07-03
15628SUPPL2006-06-28
21705ORIG2005-08-24
44479ORIG2005-03-18
37094ORIG2005-03-18
5573ORIG2005-03-18
64020ORIG1900-01-01
64019ORIG1900-01-01
64018ORIG1900-01-01
64017ORIG1900-01-01
64016ORIG1900-01-01
64015ORIG1900-01-01
63176SUPPL1900-01-01
51375SUPPL1900-01-01
51374SUPPL1900-01-01
51373SUPPL1900-01-01