FDA.reportPublic FDA data

Application 204203

Type
ANDA
Sponsor
LUPIN LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001QUETIAPINE FUMARATEQUETIAPINE FUMARATETABLET, EXTENDED RELEASE;ORALEQ 50MG BASENoNo
002QUETIAPINE FUMARATEQUETIAPINE FUMARATETABLET, EXTENDED RELEASE;ORALEQ 150MG BASENoNo
003QUETIAPINE FUMARATEQUETIAPINE FUMARATETABLET, EXTENDED RELEASE;ORALEQ 200MG BASENoNo
004QUETIAPINE FUMARATEQUETIAPINE FUMARATETABLET, EXTENDED RELEASE;ORALEQ 300MG BASENoNo
005QUETIAPINE FUMARATEQUETIAPINE FUMARATETABLET, EXTENDED RELEASE;ORALEQ 400MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0904-6801Quetiapine fumarateQuetiapine fumarateMajor PharmaceuticalsANDACurrent
0904-6801Quetiapine fumarateQuetiapine fumarateMajor PharmaceuticalsANDACurrent
0904-6801Quetiapine fumarateQuetiapine fumarateMajor PharmaceuticalsANDACurrent
0904-6801Quetiapine fumarateQuetiapine fumarateMajor PharmaceuticalsANDACurrent
0904-6801Quetiapine fumarateQuetiapine fumarateMajor PharmaceuticalsANDACurrent
0904-6802Quetiapine fumarateQuetiapine fumarateMajor PharmaceuticalsANDACurrent
0904-6802Quetiapine fumarateQuetiapine fumarateMajor PharmaceuticalsANDACurrent
0904-6802Quetiapine fumarateQuetiapine fumarateMajor PharmaceuticalsANDACurrent
0904-6802Quetiapine fumarateQuetiapine fumarateMajor PharmaceuticalsANDACurrent
0904-6802Quetiapine fumarateQuetiapine fumarateMajor PharmaceuticalsANDACurrent
0904-6803Quetiapine fumarateQuetiapine fumarateMajor PharmaceuticalsANDACurrent
0904-6803Quetiapine fumarateQuetiapine fumarateMajor PharmaceuticalsANDACurrent
0904-6803Quetiapine fumarateQuetiapine fumarateMajor PharmaceuticalsANDACurrent
0904-6803Quetiapine fumarateQuetiapine fumarateMajor PharmaceuticalsANDACurrent
0904-6803Quetiapine fumarateQuetiapine fumarateMajor PharmaceuticalsANDACurrent
0904-6804Quetiapine fumarateQuetiapine fumarateMajor PharmaceuticalsANDACurrent
0904-6804Quetiapine fumarateQuetiapine fumarateMajor PharmaceuticalsANDACurrent
0904-6804Quetiapine fumarateQuetiapine fumarateMajor PharmaceuticalsANDACurrent
0904-6804Quetiapine fumarateQuetiapine fumarateMajor PharmaceuticalsANDACurrent
0904-6804Quetiapine fumarateQuetiapine fumarateMajor PharmaceuticalsANDACurrent
0904-6805Quetiapine fumarateQuetiapine fumarateMajor PharmaceuticalsANDACurrent
0904-6805Quetiapine fumarateQuetiapine fumarateMajor PharmaceuticalsANDACurrent
0904-6805Quetiapine fumarateQuetiapine fumarateMajor PharmaceuticalsANDACurrent
0904-6805Quetiapine fumarateQuetiapine fumarateMajor PharmaceuticalsANDACurrent
0904-6805Quetiapine fumarateQuetiapine fumarateMajor PharmaceuticalsANDACurrent
68180-612Quetiapine fumarateQuetiapine fumarateLupin Pharmaceuticals, Inc.ANDACurrent
68180-612Quetiapine fumarateQuetiapine fumarateLupin Pharmaceuticals, Inc.ANDACurrent
68180-612Quetiapine fumarateQuetiapine fumarateLupin Pharmaceuticals, Inc.ANDACurrent
68180-612Quetiapine fumarateQuetiapine fumarateLupin Pharmaceuticals, Inc.ANDACurrent
68180-612Quetiapine fumarateQuetiapine fumarateLupin Pharmaceuticals, Inc.ANDACurrent
68180-612Quetiapine fumarateQuetiapine fumarateLupin Pharmaceuticals, Inc.ANDACurrent
68180-613Quetiapine fumarateQuetiapine fumarateLupin Pharmaceuticals, Inc.ANDACurrent
68180-613Quetiapine fumarateQuetiapine fumarateLupin Pharmaceuticals, Inc.ANDACurrent
68180-613Quetiapine fumarateQuetiapine fumarateLupin Pharmaceuticals, Inc.ANDACurrent
68180-613Quetiapine fumarateQuetiapine fumarateLupin Pharmaceuticals, Inc.ANDACurrent
68180-613Quetiapine fumarateQuetiapine fumarateLupin Pharmaceuticals, Inc.ANDACurrent
68180-613Quetiapine fumarateQuetiapine fumarateLupin Pharmaceuticals, Inc.ANDACurrent
68180-614Quetiapine fumarateQuetiapine fumarateLupin Pharmaceuticals, Inc.ANDACurrent
68180-614Quetiapine fumarateQuetiapine fumarateLupin Pharmaceuticals, Inc.ANDACurrent
68180-614Quetiapine fumarateQuetiapine fumarateLupin Pharmaceuticals, Inc.ANDACurrent
68180-614Quetiapine fumarateQuetiapine fumarateLupin Pharmaceuticals, Inc.ANDACurrent
68180-614Quetiapine fumarateQuetiapine fumarateLupin Pharmaceuticals, Inc.ANDACurrent
68180-614Quetiapine fumarateQuetiapine fumarateLupin Pharmaceuticals, Inc.ANDACurrent
68180-615Quetiapine fumarateQuetiapine fumarateLupin Pharmaceuticals, Inc.ANDACurrent
68180-615Quetiapine fumarateQuetiapine fumarateLupin Pharmaceuticals, Inc.ANDACurrent
68180-615Quetiapine fumarateQuetiapine fumarateLupin Pharmaceuticals, Inc.ANDACurrent
68180-615Quetiapine fumarateQuetiapine fumarateLupin Pharmaceuticals, Inc.ANDACurrent
68180-615Quetiapine fumarateQuetiapine fumarateLupin Pharmaceuticals, Inc.ANDACurrent
68180-615Quetiapine fumarateQuetiapine fumarateLupin Pharmaceuticals, Inc.ANDACurrent
68180-616Quetiapine fumarateQuetiapine fumarateLupin Pharmaceuticals, Inc.ANDACurrent
68180-616Quetiapine fumarateQuetiapine fumarateLupin Pharmaceuticals, Inc.ANDACurrent
68180-616Quetiapine fumarateQuetiapine fumarateLupin Pharmaceuticals, Inc.ANDACurrent
68180-616Quetiapine fumarateQuetiapine fumarateLupin Pharmaceuticals, Inc.ANDACurrent
68180-616Quetiapine fumarateQuetiapine fumarateLupin Pharmaceuticals, Inc.ANDACurrent
68180-616Quetiapine fumarateQuetiapine fumarateLupin Pharmaceuticals, Inc.ANDACurrent
70518-0988Quetiapine fumarateQuetiapine fumarateREMEDYREPACK INC.ANDACurrent
70518-1935Quetiapine fumarateQuetiapine fumarateREMEDYREPACK INC.ANDACurrent
70518-2646Quetiapine fumarateQuetiapine fumarateREMEDYREPACK INC.ANDACurrent
70518-2646Quetiapine fumarateQuetiapine fumarateREMEDYREPACK INC.ANDACurrent
70518-2701Quetiapine fumarateQuetiapine fumarateREMEDYREPACK INC.ANDACurrent
70518-2701Quetiapine fumarateQuetiapine fumarateREMEDYREPACK INC.ANDACurrent