Application 076911

Type
ANDA
Sponsor
SUN PHARM INDS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CLORAZEPATE DIPOTASSIUMCLORAZEPATE DIPOTASSIUMTABLET;ORAL3.75MGNoNo
002CLORAZEPATE DIPOTASSIUMCLORAZEPATE DIPOTASSIUMTABLET;ORAL7.5MGNoNo
003CLORAZEPATE DIPOTASSIUMCLORAZEPATE DIPOTASSIUMTABLET;ORAL15MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
63304-552Clorazepate dipotassiumClorazepate dipotassiumRanbaxy Pharmaceuticals Inc.ANDACurrent
63304-553Clorazepate dipotassiumClorazepate dipotassiumRanbaxy Pharmaceuticals Inc.ANDACurrent
63304-554Clorazepate dipotassiumClorazepate dipotassiumRanbaxy Pharmaceuticals Inc.ANDACurrent
63629-3858Clorazepate dipotassiumClorazepate dipotassiumBryant Ranch PrepackANDACurrent
67046-904Clorazepate dipotassiumClorazepate dipotassiumContract Pharmacy Services-PAANDACurrent
67046-907Clorazepate dipotassiumClorazepate dipotassiumContract Pharmacy Services-PAANDACurrent