FDA.reportPublic FDA data

Application 213730

Type
ANDA
Sponsor
NOVITIUM PHARMA

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
70954-157Clorazepate DipotassiumClorazepate DipotassiumANI Pharmaceuticals, Inc.ANDACurrent
70954-158Clorazepate DipotassiumClorazepate DipotassiumANI Pharmaceuticals, Inc.ANDACurrent
70954-158Clorazepate DipotassiumClorazepate DipotassiumNovitium Pharma LLCANDACurrent
70954-158Clorazepate DipotassiumClorazepate DipotassiumNovitium Pharma LLCANDACurrent
70954-159Clorazepate DipotassiumClorazepate DipotassiumANI Pharmaceuticals, Inc.ANDACurrent
70954-159Clorazepate DipotassiumClorazepate DipotassiumNovitium Pharma LLCANDACurrent
70954-159Clorazepate DipotassiumClorazepate DipotassiumNovitium Pharma LLCANDACurrent