FDA.report

Application 077745

Type
ANDA
Sponsor
TEVA PHARMS

Related Records

Application Products

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 150MG BASENoNo
005QUETIAPINE FUMARATEQUETIAPINE FUMARATETABLET;ORALEQ 200MG BASENoNo
006QUETIAPINE FUMARATEQUETIAPINE FUMARATETABLET;ORALEQ 300MG BASENoNo
007QUETIAPINE FUMARATEQUETIAPINE FUMARATETABLET;ORALEQ 400MG BASENoNo

NDC Listings For This Application

NDCNameNonproprietary nameLabelerMarketing categoryStatus
0093-2063QuetiapineQuetiapineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-2063QuetiapineQuetiapineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-2063QuetiapineQuetiapineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-2063QuetiapineQuetiapineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-2063QuetiapineQuetiapineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-2063QuetiapineQuetiapineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-2063QuetiapineQuetiapineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-2063QuetiapineQuetiapineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-8162QuetiapineQuetiapineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-8162QuetiapineQuetiapineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-8162QuetiapineQuetiapineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-8162QuetiapineQuetiapineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-8162QuetiapineQuetiapineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-8162QuetiapineQuetiapineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-8162QuetiapineQuetiapineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-8162QuetiapineQuetiapineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-8163QuetiapineQuetiapineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-8163QuetiapineQuetiapineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-8163QuetiapineQuetiapineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-8163QuetiapineQuetiapineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-8163QuetiapineQuetiapineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-8163QuetiapineQuetiapineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-8163QuetiapineQuetiapineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-8163QuetiapineQuetiapineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-8164QuetiapineQuetiapineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-8164QuetiapineQuetiapineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-8164QuetiapineQuetiapineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-8164QuetiapineQuetiapineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-8164QuetiapineQuetiapineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-8164QuetiapineQuetiapineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-8164QuetiapineQuetiapineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-8164QuetiapineQuetiapineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-8165QuetiapineQuetiapineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-8165QuetiapineQuetiapineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-8165QuetiapineQuetiapineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-8165QuetiapineQuetiapineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-8165QuetiapineQuetiapineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-8165QuetiapineQuetiapineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-8165QuetiapineQuetiapineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-8165QuetiapineQuetiapineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-8166QuetiapineQuetiapineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-8166QuetiapineQuetiapineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-8166QuetiapineQuetiapineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-8166QuetiapineQuetiapineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-8166QuetiapineQuetiapineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-8166QuetiapineQuetiapineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-8166QuetiapineQuetiapineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-8166QuetiapineQuetiapineTeva Pharmaceuticals USA, Inc.ANDACurrent
0615-7724Quetiapine FumarateQuetiapine FumarateNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-7725Quetiapine FumarateQuetiapine FumarateNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-7726Quetiapine FumarateQuetiapine FumarateNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-7727Quetiapine FumarateQuetiapine FumarateNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-7728Quetiapine FumarateQuetiapine FumarateNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-7846Quetiapine FumarateQuetiapine FumarateNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
42291-695QuetiapineQuetiapineAvKAREANDACurrent
42291-696QuetiapineQuetiapineAvKAREANDACurrent
42291-697QuetiapineQuetiapineAvKAREANDACurrent
42291-698QuetiapineQuetiapineAvKAREANDACurrent
42291-699QuetiapineQuetiapineAvKAREANDACurrent
42291-700QuetiapineQuetiapineAvKAREANDACurrent
43353-011Quetiapine FumarateQuetiapine FumarateAphena Pharma Solutions - Tennessee, LLCANDACurrent
43353-955Quetiapine FumarateQuetiapine FumarateAphena Pharma Solutions - Tennessee, LLCANDACurrent
43353-957Quetiapine FumarateQuetiapine FumarateAphena Pharma Solutions - Tennessee, LLCANDACurrent
64725-8166Quetiapine FumarateQuetiapine FumarateTYA PharmaceuticalsANDACurrent
71205-026QuetiapineQuetiapineProficient Rx LPANDACurrent
71205-026QuetiapineQuetiapineProficient Rx LPANDACurrent
71205-026QuetiapineQuetiapineProficient Rx LPANDACurrent
71205-026QuetiapineQuetiapineProficient Rx LPANDACurrent
71205-402QuetiapineQuetiapineProficient Rx LPANDACurrent
71610-538QuetiapineQuetiapineAphena Pharma Solutions - Tennessee, LLCANDACurrent

Documents

DocumentTitleSubmission typeSubmission no.Date
312870ORIG12012-03-29