FDA.reportPublic FDA data

Application 078678

Type
ANDA
Sponsor
ORCHID HLTHCARE

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
16714-221Granisetron HydrochlorideGranisetron HydrochlorideNorthstar Rx LLCANDACurrent
16714-221Granisetron HydrochlorideGranisetron HydrochlorideNorthstar Rx LLCANDACurrent
16714-221Granisetron HydrochlorideGranisetron HydrochlorideNorthstar Rx LLCANDACurrent
16714-221Granisetron HydrochlorideGranisetron HydrochlorideNorthstar Rx LLCANDACurrent
42043-390Granisetron HydrochlorideGranisetron HydrochlorideOrchidPharma IncANDACurrent
42043-390Granisetron HydrochlorideGranisetron HydrochlorideOrchidPharma IncANDACurrent
42043-390Granisetron HydrochlorideGranisetron HydrochlorideOrchidPharma IncANDACurrent
69452-350Granisetron HydrochlorideGranisetron HydrochlorideBionpharma Inc.ANDACurrent