FDA.reportPublic FDA data

Application 075731

Type
ANDA
Sponsor
TARO

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
21695-433Clorazepate DipotassiumClorazepate DipotassiumRebel Distributors CorpANDACurrent
21695-434Clorazepate DipotassiumClorazepate DipotassiumRebel Distributors CorpANDACurrent
43063-893Clorazepate DipotassiumClorazepate DipotassiumPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-893Clorazepate DipotassiumClorazepate DipotassiumPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-893Clorazepate DipotassiumClorazepate DipotassiumPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-893Clorazepate DipotassiumClorazepate DipotassiumPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-893Clorazepate DipotassiumClorazepate DipotassiumPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-893Clorazepate DipotassiumClorazepate DipotassiumPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-893Clorazepate DipotassiumClorazepate DipotassiumPD-Rx Pharmaceuticals, Inc.ANDACurrent
51672-4042Clorazepate DipotassiumClorazepate DipotassiumTaro Pharmaceuticals U.S.A., Inc.ANDACurrent
51672-4042Clorazepate DipotassiumClorazepate DipotassiumTaro Pharmaceuticals U.S.A., Inc.ANDACurrent
51672-4042Clorazepate DipotassiumClorazepate DipotassiumTaro Pharmaceuticals U.S.A., Inc.ANDACurrent
51672-4043Clorazepate DipotassiumClorazepate DipotassiumTaro Pharmaceuticals U.S.A., Inc.ANDACurrent
51672-4043Clorazepate DipotassiumClorazepate DipotassiumTaro Pharmaceuticals U.S.A., Inc.ANDACurrent
51672-4043Clorazepate DipotassiumClorazepate DipotassiumTaro Pharmaceuticals U.S.A., Inc.ANDACurrent
51672-4044Clorazepate DipotassiumClorazepate DipotassiumTaro Pharmaceuticals U.S.A., Inc.ANDACurrent
51672-4044Clorazepate DipotassiumClorazepate DipotassiumTaro Pharmaceuticals U.S.A., Inc.ANDACurrent
51672-4044Clorazepate DipotassiumClorazepate DipotassiumTaro Pharmaceuticals U.S.A., Inc.ANDACurrent
63629-3646Clorazepate DipotassiumClorazepate DipotassiumBryant Ranch PrepackANDACurrent
63629-3859Clorazepate DipotassiumClorazepate DipotassiumBryant Ranch PrepackANDACurrent
72603-112Clorazepate DipotassiumClorazepate DipotassiumNORTHSTAR RX LLCANDACurrent
72603-113Clorazepate DipotassiumClorazepate DipotassiumNORTHSTAR RX LLCANDACurrent
72603-114Clorazepate DipotassiumClorazepate DipotassiumNORTHSTAR RX LLCANDACurrent
72789-256Clorazepate DipotassiumClorazepate DipotassiumPD-Rx Pharmaceuticals, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
31001ORIG2000-04-27