FDA.reportPublic FDA data

Application 211405

Type
ANDA
Sponsor
AMNEAL PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001QUETIAPINE FUMARATEQUETIAPINE FUMARATETABLET, EXTENDED RELEASE;ORALEQ 400MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
65162-431QuetiapineQuetiapine Extended-releaseAmneal Pharmaceuticals LLCANDACurrent
65162-431QuetiapineQuetiapine Extended-releaseAmneal Pharmaceuticals LLCANDACurrent
65162-431QuetiapineQuetiapine Extended-releaseAmneal Pharmaceuticals LLCANDACurrent
65162-431QuetiapineQuetiapine Extended-releaseAmneal Pharmaceuticals LLCANDACurrent
65162-431QuetiapineQuetiapine Extended-releaseAmneal Pharmaceuticals LLCANDACurrent
65162-431QuetiapineQuetiapine Extended-releaseAmneal Pharmaceuticals LLCANDACurrent
65162-431QuetiapineQuetiapine Extended-releaseAmneal Pharmaceuticals LLCANDACurrent