FDA.report

Application 201190

Type
ANDA
Sponsor
SUN PHARM

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

NDC Listings For This Application

NDCNameNonproprietary nameLabelerMarketing categoryStatus
47335-902Quetiapine fumarateQuetiapine fumarateSun Pharmaceutical Industries, Inc.ANDACurrent
47335-902Quetiapine fumarateQuetiapine fumarateSun Pharmaceutical Industries, Inc.ANDACurrent
47335-902Quetiapine fumarateQuetiapine fumarateSun Pharmaceutical Industries, Inc.ANDACurrent
47335-902Quetiapine fumarateQuetiapine fumarateSun Pharmaceutical Industries, Inc.ANDACurrent
47335-902Quetiapine fumarateQuetiapine fumarateSun Pharmaceutical Industries, Inc.ANDACurrent
47335-903Quetiapine fumarateQuetiapine fumarateSun Pharmaceutical Industries, Inc.ANDACurrent
47335-903Quetiapine fumarateQuetiapine fumarateSun Pharmaceutical Industries, Inc.ANDACurrent
47335-903Quetiapine fumarateQuetiapine fumarateSun Pharmaceutical Industries, Inc.ANDACurrent
47335-903Quetiapine fumarateQuetiapine fumarateSun Pharmaceutical Industries, Inc.ANDACurrent
47335-903Quetiapine fumarateQuetiapine fumarateSun Pharmaceutical Industries, Inc.ANDACurrent
47335-904Quetiapine fumarateQuetiapine fumarateSun Pharmaceutical Industries, Inc.ANDACurrent
47335-904Quetiapine fumarateQuetiapine fumarateSun Pharmaceutical Industries, Inc.ANDACurrent
47335-904Quetiapine fumarateQuetiapine fumarateSun Pharmaceutical Industries, Inc.ANDACurrent
47335-904Quetiapine fumarateQuetiapine fumarateSun Pharmaceutical Industries, Inc.ANDACurrent
47335-904Quetiapine fumarateQuetiapine fumarateSun Pharmaceutical Industries, Inc.ANDACurrent
47335-905Quetiapine fumarateQuetiapine fumarateSun Pharmaceutical Industries, Inc.ANDACurrent
47335-905Quetiapine fumarateQuetiapine fumarateSun Pharmaceutical Industries, Inc.ANDACurrent
47335-905Quetiapine fumarateQuetiapine fumarateSun Pharmaceutical Industries, Inc.ANDACurrent
47335-905Quetiapine fumarateQuetiapine fumarateSun Pharmaceutical Industries, Inc.ANDACurrent
47335-905Quetiapine fumarateQuetiapine fumarateSun Pharmaceutical Industries, Inc.ANDACurrent
47335-906Quetiapine fumarateQuetiapine fumarateSun Pharmaceutical Industries, Inc.ANDACurrent
47335-906Quetiapine fumarateQuetiapine fumarateSun Pharmaceutical Industries, Inc.ANDACurrent
47335-906Quetiapine fumarateQuetiapine fumarateSun Pharmaceutical Industries, Inc.ANDACurrent
47335-906Quetiapine fumarateQuetiapine fumarateSun Pharmaceutical Industries, Inc.ANDACurrent
47335-906Quetiapine fumarateQuetiapine fumarateSun Pharmaceutical Industries, Inc.ANDACurrent
47335-907Quetiapine fumarateQuetiapine fumarateSun Pharmaceutical Industries, Inc.ANDACurrent
47335-907Quetiapine fumarateQuetiapine fumarateSun Pharmaceutical Industries, Inc.ANDACurrent
47335-907Quetiapine fumarateQuetiapine fumarateSun Pharmaceutical Industries, Inc.ANDACurrent
47335-907Quetiapine fumarateQuetiapine fumarateSun Pharmaceutical Industries, Inc.ANDACurrent
47335-907Quetiapine fumarateQuetiapine fumarateSun Pharmaceutical Industries, Inc.ANDACurrent
55700-084Quetiapine fumarateQuetiapine fumarateLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-085Quetiapine fumarateQuetiapine fumarateLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-085Quetiapine fumarateQuetiapine fumarateLake Erie Medical DBA QuaANDACurrent
55700-156Quetiapine fumarateQuetiapine fumarateLake Erie Medical DBA Quality Care Products LLCANDACurrent
68071-2728Quetiapine fumarateQuetiapine fumarateNuCare Pharmaceuticals,Inc.ANDACurrent
68788-7950Quetiapine fumarateQuetiapine fumaratePreferred Pharmaceuticals Inc.ANDACurrent
68788-7950Quetiapine fumarateQuetiapine fumaratePreferred Pharmaceuticals Inc.ANDACurrent
68788-7960Quetiapine fumarateQuetiapine fumaratePreferred Pharmaceuticals Inc.ANDACurrent
68788-7960Quetiapine fumarateQuetiapine fumaratePreferred Pharmaceuticals Inc.ANDACurrent
70518-0556Quetiapine fumarateQuetiapine fumarateREMEDYREPACK INC.ANDACurrent
70518-0556Quetiapine fumarateQuetiapine fumarateREMEDYREPACK INC.ANDACurrent
70518-0594Quetiapine fumarateQuetiapine fumarateREMEDYREPACK INC.ANDACurrent
70518-0594Quetiapine fumarateQuetiapine fumarateREMEDYREPACK INC.ANDACurrent
70518-0594Quetiapine fumarateQuetiapine fumarateREMEDYREPACK INC.ANDACurrent
70518-0767Quetiapine fumarateQuetiapine fumarateREMEDYREPACK INC.ANDACurrent
70518-0767Quetiapine fumarateQuetiapine fumarateREMEDYREPACK INC.ANDACurrent
70518-0767Quetiapine fumarateQuetiapine fumarateREMEDYREPACK INC.ANDACurrent
70518-1126Quetiapine fumarateQuetiapine fumarateREMEDYREPACK INC.ANDACurrent
70518-1126Quetiapine fumarateQuetiapine fumarateREMEDYREPACK INC.ANDACurrent
70518-1833Quetiapine fumarateQuetiapine fumarateREMEDYREPACK INC.ANDACurrent
71335-0772Quetiapine fumarateQuetiapine fumarateBryant Ranch PrepackANDACurrent
71335-0772Quetiapine fumarateQuetiapine fumarateBryant Ranch PrepackANDACurrent
71335-0772Quetiapine fumarateQuetiapine fumarateBryant Ranch PrepackANDACurrent
71335-0772Quetiapine fumarateQuetiapine fumarateBryant Ranch PrepackANDACurrent
71335-2157Quetiapine fumarateQuetiapine fumarateBryant Ranch PrepackANDACurrent
71335-2157Quetiapine fumarateQuetiapine fumarateBryant Ranch PrepackANDACurrent
71335-2176Quetiapine fumarateQuetiapine fumarateBryant Ranch PrepackANDACurrent