FDA.reportPublic FDA data

Application 200652

Type
ANDA
Sponsor
HIKMA

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
0054-0295Alosetron Hydrochloridealosetron hydrochlorideWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-0295Alosetron Hydrochloridealosetron hydrochlorideWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-0295Alosetron Hydrochloridealosetron hydrochlorideWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-0295Alosetron Hydrochloridealosetron hydrochlorideWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-0296Alosetron Hydrochloridealosetron hydrochlorideWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-0296Alosetron Hydrochloridealosetron hydrochlorideWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-0296Alosetron Hydrochloridealosetron hydrochlorideWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-0296Alosetron Hydrochloridealosetron hydrochlorideWest-Ward Pharmaceuticals Corp.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
75381SUPPL 2023-09-08
69135SUPPL2021-10-27
62295SUPPL2020-03-24
50040APPL2017-10-12
46778SUPPL2017-01-10
40036ORIG2015-05-07
9837ORIG2015-05-05