FDA.reportPublic FDA data

Application 202292

Type
NDA
Sponsor
NAPO PHARMS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MYTESICROFELEMERTABLET, DELAYED RELEASE;ORAL125MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
70564-802MYTESICrofelemerNapo Pharmaceuticals, Inc.NDACurrent
70564-802MYTESICrofelemerNapo Pharmaceuticals, Inc.NDACurrent
70564-802MYTESICrofelemerNapo Pharmaceuticals, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
78071SUPPL 2024-04-04
78061SUPPL 2024-04-04
65252SUPPL2020-11-17
65248SUPPL2020-11-16
52910SUPPL2018-03-12
52876SUPPL2018-03-08
44851ORIG2013-02-19
43394ORIG2013-02-19
32228ORIG2013-01-02
19313ORIG2012-12-31