FDA.reportPublic FDA data

Application 204316

Type
ANDA
Sponsor
HETERO LABS LTD V

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001QUETIAPINE FUMARATEQUETIAPINE FUMARATETABLET;ORALEQ 25MG BASENoNo
002QUETIAPINE FUMARATEQUETIAPINE FUMARATETABLET;ORALEQ 50MG BASENoNo
003QUETIAPINE FUMARATEQUETIAPINE FUMARATETABLET;ORALEQ 100MG BASENoNo
004QUETIAPINE FUMARATEQUETIAPINE FUMARATETABLET;ORALEQ 200MG BASENoNo
005QUETIAPINE FUMARATEQUETIAPINE FUMARATETABLET;ORALEQ 300MG BASENoNo
006QUETIAPINE FUMARATEQUETIAPINE FUMARATETABLET;ORALEQ 400MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
31722-764Quetiapine FumarateQuetiapine FumarateCamber Pharmaceuticals, Inc.ANDACurrent
31722-764Quetiapine FumarateQuetiapine FumarateCamber Pharmaceuticals, Inc.ANDACurrent
31722-765Quetiapine FumarateQuetiapine FumarateCamber Pharmaceuticals, Inc.ANDACurrent
31722-765Quetiapine FumarateQuetiapine FumarateCamber Pharmaceuticals, Inc.ANDACurrent
31722-766Quetiapine FumarateQuetiapine FumarateCamber Pharmaceuticals, Inc.ANDACurrent
31722-766Quetiapine FumarateQuetiapine FumarateCamber Pharmaceuticals, Inc.ANDACurrent
31722-767Quetiapine FumarateQuetiapine FumarateCamber Pharmaceuticals, Inc.ANDACurrent
31722-767Quetiapine FumarateQuetiapine FumarateCamber Pharmaceuticals, Inc.ANDACurrent
31722-768Quetiapine FumarateQuetiapine FumarateCamber Pharmaceuticals, Inc.ANDACurrent
31722-768Quetiapine FumarateQuetiapine FumarateCamber Pharmaceuticals, Inc.ANDACurrent
31722-769Quetiapine FumarateQuetiapine FumarateCamber Pharmaceuticals, Inc.ANDACurrent
31722-769Quetiapine FumarateQuetiapine FumarateCamber Pharmaceuticals, Inc.ANDACurrent