Application 090681

Type
ANDA
Sponsor
ACCORD HLTHCARE

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001QUETIAPINE FUMARATEQUETIAPINE FUMARATETABLET, EXTENDED RELEASE;ORALEQ 150MG BASENoNo
002QUETIAPINE FUMARATEQUETIAPINE FUMARATETABLET, EXTENDED RELEASE;ORALEQ 200MG BASENoNo
003QUETIAPINE FUMARATEQUETIAPINE FUMARATETABLET, EXTENDED RELEASE;ORALEQ 300MG BASENoNo
004QUETIAPINE FUMARATEQUETIAPINE FUMARATETABLET, EXTENDED RELEASE;ORALEQ 400MG BASENoNo

NDC Listings For This Application

NDCNameNonproprietary nameLabelerMarketing categoryStatus
16729-095QUETIAPINE FUMARATEQUETIAPINE FUMARATEAccord Healthcare Inc.ANDACurrent
16729-095QUETIAPINE FUMARATEQUETIAPINE FUMARATEAccord Healthcare Inc.ANDACurrent
16729-095QUETIAPINE FUMARATEQUETIAPINE FUMARATEAccord Healthcare Inc.ANDACurrent
16729-095QUETIAPINE FUMARATEQUETIAPINE FUMARATEAccord Healthcare Inc.ANDACurrent
16729-096QUETIAPINE FUMARATEQUETIAPINE FUMARATEAccord Healthcare Inc.ANDACurrent
16729-096QUETIAPINE FUMARATEQUETIAPINE FUMARATEAccord Healthcare Inc.ANDACurrent
16729-096QUETIAPINE FUMARATEQUETIAPINE FUMARATEAccord Healthcare Inc.ANDACurrent
16729-096QUETIAPINE FUMARATEQUETIAPINE FUMARATEAccord Healthcare Inc.ANDACurrent
16729-097QUETIAPINE FUMARATEQUETIAPINE FUMARATEAccord Healthcare Inc.ANDACurrent
16729-097QUETIAPINE FUMARATEQUETIAPINE FUMARATEAccord Healthcare Inc.ANDACurrent
16729-097QUETIAPINE FUMARATEQUETIAPINE FUMARATEAccord Healthcare Inc.ANDACurrent
16729-097QUETIAPINE FUMARATEQUETIAPINE FUMARATEAccord Healthcare Inc.ANDACurrent
16729-109QUETIAPINE FUMARATEQUETIAPINE FUMARATEAccord Healthcare Inc.ANDACurrent
16729-109QUETIAPINE FUMARATEQUETIAPINE FUMARATEAccord Healthcare Inc.ANDACurrent
16729-109QUETIAPINE FUMARATEQUETIAPINE FUMARATEAccord Healthcare Inc.ANDACurrent
16729-109QUETIAPINE FUMARATEQUETIAPINE FUMARATEAccord Healthcare Inc.ANDACurrent
50090-3198QUETIAPINE FUMARATEQUETIAPINE FUMARATEA-S Medication SolutionsANDACurrent
50090-3198QUETIAPINE FUMARATEquetiapine fumarateA-S Medication SolutionsANDACurrent
50090-5442QUETIAPINE FUMARATEQUETIAPINE FUMARATEA-S Medication SolutionsANDACurrent
68001-512QUETIAPINE FUMARATEQUETIAPINE FUMARATEBluepoint LaboratoriesANDACurrent
68001-512QUETIAPINE FUMARATEQUETIAPINE FUMARATEBluepoint LaboratoriesANDACurrent
68001-513QUETIAPINE FUMARATEQUETIAPINE FUMARATEBluepoint LaboratoriesANDACurrent
68001-513QUETIAPINE FUMARATEQUETIAPINE FUMARATEBluepoint LaboratoriesANDACurrent
68001-514QUETIAPINE FUMARATEQUETIAPINE FUMARATEBluepoint LaboratoriesANDACurrent
68001-514QUETIAPINE FUMARATEQUETIAPINE FUMARATEBluepoint LaboratoriesANDACurrent
68001-515QUETIAPINE FUMARATEQUETIAPINE FUMARATEBluepoint LaboratoriesANDACurrent
68001-515QUETIAPINE FUMARATEQUETIAPINE FUMARATEBluepoint LaboratoriesANDACurrent
70518-1841QUETIAPINE FUMARATEquetiapine fumarateREMEDYREPACK INC.ANDACurrent
70518-1841QUETIAPINE FUMARATEQUETIAPINE FUMARATEREMEDYREPACK INC.ANDACurrent
70518-1841QUETIAPINE FUMARATEQUETIAPINE FUMARATEREMEDYREPACK INC.ANDACurrent
70518-1841QUETIAPINE FUMARATEQUETIAPINE FUMARATEREMEDYREPACK INC.ANDACurrent
70518-1841QUETIAPINE FUMARATEQUETIAPINE FUMARATEREMEDYREPACK INC.ANDACurrent
70518-1985QUETIAPINE FUMARATEQUETIAPINE FUMARATEREMEDYREPACK INC.ANDACurrent
70518-2238QUETIAPINE FUMARATEQUETIAPINE FUMARATEREMEDYREPACK INC.ANDACurrent

Documents

DocumentSubmission typeDate
48373ORIG2017-05-15
48362ORIG2017-05-12
45926ORIG2016-11-08
45795ORIG2016-11-02