FDA.reportPublic FDA data

Application 078080

Type
ANDA
Sponsor
TEVA PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001GRANISETRON HYDROCHLORIDEGRANISETRON HYDROCHLORIDETABLET;ORALEQ 1MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0093-7485Granisetron HydrochlorideGranisetron HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7485Granisetron HydrochlorideGranisetron HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
31327SUPPL2014-09-24
18473SUPPL2014-09-23
39551SUPPL2012-04-30