FDA.reportPublic FDA data

Application 077535

Type
ANDA
Sponsor
GLENMARK GENERICS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ONDANSETRON HYDROCHLORIDEONDANSETRON HYDROCHLORIDETABLET;ORALEQ 4MG BASENoNo
002ONDANSETRON HYDROCHLORIDEONDANSETRON HYDROCHLORIDETABLET;ORALEQ 8MG BASENoNo
003ONDANSETRON HYDROCHLORIDEONDANSETRON HYDROCHLORIDETABLET;ORALEQ 24MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
43063-770OndansetronOndansetronPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-770OndansetronOndansetronPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-770OndansetronOndansetronPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-770OndansetronOndansetronPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-770OndansetronOndansetronPD-Rx Pharmaceuticals, Inc.ANDACurrent
63629-5073OndansetronOndansetronBryant Ranch PrepackANDACurrent
63629-5083OndansetronOndansetronBryant Ranch PrepackANDACurrent
63629-5083OndansetronOndansetronBryant Ranch PrepackANDACurrent
68462-105OndansetronOndansetronGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-105OndansetronOndansetronGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-105OndansetronOndansetronGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-105OndansetronOndansetronGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-106OndansetronOndansetronGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-106OndansetronOndansetronGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-106OndansetronOndansetronGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-106OndansetronOndansetronGlenmark Pharmaceuticals Inc., USAANDACurrent