FDA.reportPublic FDA data

Application 209180

Type
ANDA
Sponsor
RISING

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ALOSETRON HYDROCHLORIDEALOSETRON HYDROCHLORIDETABLET;ORALEQ 0.5MG BASENoNo
002ALOSETRON HYDROCHLORIDEALOSETRON HYDROCHLORIDETABLET;ORALEQ 1MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
64980-453alosetron hydrochloridealosetron hydrochlorideRising Pharmaceuticals, Inc.ANDACurrent
64980-453alosetron hyochloridealosetron hyochlorideRising Pharmaceuticals, Inc.ANDACurrent
64980-453alosetron hydrochloridealosetron hydrochlorideRising Pharmaceuticals, Inc.ANDACurrent
64980-454alosetron hydrochloridealosetron hydrochlorideRising Pharmaceuticals, Inc.ANDACurrent
64980-454alosetron hyochloridealosetron hyochlorideRising Pharmaceuticals, Inc.ANDACurrent
64980-454alosetron hydrochloridealosetron hydrochlorideRising Pharmaceuticals, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
75384SUPPL 2023-09-08