FDA.reportPublic FDA data

Application 022206

Type
NDA
Sponsor
ALLERGAN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001RAPAFLOSILODOSINCAPSULE;ORAL4MGYesYes
002RAPAFLOSILODOSINCAPSULE;ORAL8MGYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0023-6142RAPAFLOsilodosinAllergan, Inc.NDACurrent
0023-6142RAPAFLOsilodosinAllergan, Inc.NDACurrent
0023-6142RAPAFLOsilodosinAllergan, Inc.NDACurrent
0023-6147RAPAFLOsilodosinAllergan, Inc.NDACurrent
0023-6147RAPAFLOsilodosinAllergan, Inc.NDACurrent
0023-6147RAPAFLOsilodosinAllergan, Inc.NDACurrent
52544-151RAPAFLOsilodosinActavis Pharma, Inc.NDACurrent
52544-151RAPAFLOsilodosinActavis Pharma, Inc.NDACurrent
52544-151RAPAFLOsilodosinActavis Pharma, Inc.NDACurrent
52544-152RAPAFLOsilodosinActavis Pharma, Inc.NDACurrent
52544-152RAPAFLOsilodosinActavis Pharma, Inc.NDACurrent
52544-152RAPAFLOsilodosinActavis Pharma, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
65607SUPPL2020-12-17
65602SUPPL2020-12-16
38385SUPPL2013-07-17
7050SUPPL2013-07-15
7049SUPPL2012-12-19
17087SUPPL2012-12-18
29408SUPPL2010-03-08
17086SUPPL2010-03-05
17085SUPPL2009-02-20
29407SUPPL2009-02-18
44702ORIG2008-11-17
42451ORIG2008-11-14
38384ORIG2008-11-07
7048ORIG2008-10-14