FDA.reportPublic FDA data

Application 071858

Type
ANDA
Sponsor
MYLAN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CLORAZEPATE DIPOTASSIUMCLORAZEPATE DIPOTASSIUMTABLET;ORAL15MGNoYes
002CLORAZEPATE DIPOTASSIUMCLORAZEPATE DIPOTASSIUMTABLET;ORAL3.75MGNoNo
003CLORAZEPATE DIPOTASSIUMCLORAZEPATE DIPOTASSIUMTABLET;ORAL7.5MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0378-0030Clorazepate Dipotassiumclorazepate dipotassiumMylan Pharmaceuticals Inc.ANDACurrent
0378-0030Clorazepate Dipotassiumclorazepate dipotassiumMylan Pharmaceuticals Inc.ANDACurrent
0378-0030Clorazepate Dipotassiumclorazepate dipotassiumMylan Pharmaceuticals Inc.ANDACurrent
0378-0030Clorazepate Dipotassiumclorazepate dipotassiumMylan Pharmaceuticals Inc.ANDACurrent
0378-0040Clorazepate Dipotassiumclorazepate dipotassiumMylan Pharmaceuticals Inc.ANDACurrent
0378-0040Clorazepate Dipotassiumclorazepate dipotassiumMylan Pharmaceuticals Inc.ANDACurrent
0378-0040Clorazepate Dipotassiumclorazepate dipotassiumMylan Pharmaceuticals Inc.ANDACurrent
0378-0040Clorazepate Dipotassiumclorazepate dipotassiumMylan Pharmaceuticals Inc.ANDACurrent
0378-0070Clorazepate Dipotassiumclorazepate dipotassiumMylan Pharmaceuticals Inc.ANDACurrent
0378-0070Clorazepate Dipotassiumclorazepate dipotassiumMylan Pharmaceuticals Inc.ANDACurrent
0378-0070Clorazepate Dipotassiumclorazepate dipotassiumMylan Pharmaceuticals Inc.ANDACurrent
0378-0070Clorazepate Dipotassiumclorazepate dipotassiumMylan Pharmaceuticals Inc.ANDACurrent
13107-319CLORAZEPATE DIPOTASSIUMCLORAZEPATE DIPOTASSIUMAurolife Pharma, LLCANDACurrent
13107-319CLORAZEPATE DIPOTASSIUMCLORAZEPATE DIPOTASSIUMAurolife Pharma, LLCANDACurrent
13107-320CLORAZEPATE DIPOTASSIUMCLORAZEPATE DIPOTASSIUMAurolife Pharma, LLCANDACurrent
13107-320CLORAZEPATE DIPOTASSIUMCLORAZEPATE DIPOTASSIUMAurolife Pharma, LLCANDACurrent
13107-321CLORAZEPATE DIPOTASSIUMCLORAZEPATE DIPOTASSIUMAurolife Pharma, LLCANDACurrent
13107-321CLORAZEPATE DIPOTASSIUMCLORAZEPATE DIPOTASSIUMAurolife Pharma, LLCANDACurrent
43063-030Clorazepate Dipotassiumclorazepate dipotassiumPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-030Clorazepate Dipotassiumclorazepate dipotassiumPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-030Clorazepate Dipotassiumclorazepate dipotassiumPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-030Clorazepate Dipotassiumclorazepate dipotassiumPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-030Clorazepate Dipotassiumclorazepate dipotassiumPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-030Clorazepate Dipotassiumclorazepate dipotassiumPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-164Clorazepate Dipotassiumclorazepate dipotassiumPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-350Clorazepate Dipotassiumclorazepate dipotassiumPD-Rx Pharmaceuticals, Inc.ANDACurrent
67046-906Clorazepate DipotassiumClorazepate DipotassiumContract Pharmacy Services-PAANDACurrent