FDA.reportPublic FDA data

Application 017588

Type
NDA
Sponsor
CORDEN PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001GLEOSTINELOMUSTINECAPSULE;ORAL10MGYesNo
002GLEOSTINELOMUSTINECAPSULE;ORAL40MGYesNo
003GLEOSTINELOMUSTINECAPSULE;ORAL100MGYesYes
004GLEOSTINELOMUSTINECAPSULE;ORAL5MGYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
58181-3040GleostinelomustineNextSource Biotechnology, LLCNDACurrent
58181-3040GleostinelomustineNextSource Biotechnology, LLCNDACurrent
58181-3040GleostinelomustineNextSource Biotechnology, LLCNDACurrent
58181-3041GleostinelomustineNextSource Biotechnology, LLCNDACurrent
58181-3041GleostinelomustineNextSource Biotechnology, LLCNDACurrent
58181-3041GleostinelomustineNextSource Biotechnology, LLCNDACurrent
58181-3042GleostinelomustineNextSource Biotechnology, LLCNDACurrent
58181-3042GleostinelomustineNextSource Biotechnology, LLCNDACurrent
58181-3042GleostinelomustineNextSource Biotechnology, LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
64854SUPPL2020-10-06
63588SUPPL2020-06-17
33317SUPPL2016-02-02
13864SUPPL2016-02-01
11042SUPPL2016-01-07
661SUPPL2016-01-07
33316SUPPL2014-05-28
660SUPPL2014-05-22
11041SUPPL2013-08-21
11040SUPPL2012-11-28
658SUPPL2012-11-23
33315SUPPL2011-05-16
659SUPPL2011-05-16
33314SUPPL2009-05-11
657SUPPL2009-05-06
656SUPPL2003-03-10
655SUPPL2002-12-20