FDA.reportPublic FDA data

Application 090960

Type
ANDA
Sponsor
ZENNOVA

Application Products#

Product, Drug, Ingredient table
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#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
43353-150quetiapine fumaratequetiapine fumarateAphena Pharma Solutions - Tennessee, LLCANDACurrent
43353-153quetiapine fumaratequetiapine fumarateAphena Pharma Solutions - Tennessee, LLCANDACurrent
43353-155quetiapine fumaratequetiapine fumarateAphena Pharma Solutions - Tennessee, LLCANDACurrent
43353-161quetiapine fumaratequetiapine fumarateAphena Pharma Solutions - Tennessee, LLCANDACurrent
43353-785quetiapine fumaratequetiapine fumarateAphena Pharma Solutions - Tennessee, LLCANDACurrent
43353-786quetiapine fumaratequetiapine fumarateAphena Pharma Solutions - Tennessee, LLCANDACurrent
43353-788quetiapine fumaratequetiapine fumarateAphena Pharma Solutions - Tennessee, LLCANDACurrent
43353-847quetiapine fumaratequetiapine fumarateAphena Pharma Solutions - Tennessee, LLCANDACurrent
43353-852quetiapine fumaratequetiapine fumarateAphena Pharma Solutions - Tennessee, LLCANDACurrent
50090-2914quetiapine fumaratequetiapine fumarateA-S Medication SolutionsANDACurrent
50090-2932quetiapine fumaratequetiapine fumarateA-S Medication SolutionsANDACurrent
50090-2966quetiapine fumaratequetiapine fumarateA-S Medication SolutionsANDACurrent
50090-3370quetiapine fumaratequetiapine fumarateA-S Medication SolutionsANDACurrent
60429-413quetiapine fumaratequetiapine fumarateGolden State Medical Supply, Inc.ANDACurrent
60429-413quetiapine fumaratequetiapine fumarateGolden State Medical Supply, Inc.ANDACurrent
60429-414quetiapine fumaratequetiapine fumarateGolden State Medical Supply, Inc.ANDACurrent
60429-414quetiapine fumaratequetiapine fumarateGolden State Medical Supply, Inc.ANDACurrent
60429-415quetiapine fumaratequetiapine fumarateGolden State Medical Supply, Inc.ANDACurrent
60429-415quetiapine fumaratequetiapine fumarateGolden State Medical Supply, Inc.ANDACurrent
60429-416quetiapine fumaratequetiapine fumarateGolden State Medical Supply, Inc.ANDACurrent
60429-416quetiapine fumaratequetiapine fumarateGolden State Medical Supply, Inc.ANDACurrent
60429-416quetiapine fumaratequetiapine fumarateGolden State Medical Supply, Inc.ANDACurrent
60429-417quetiapine fumaratequetiapine fumarateGolden State Medical Supply, Inc.ANDACurrent
60429-417quetiapine fumaratequetiapine fumarateGolden State Medical Supply, Inc.ANDACurrent
60429-418quetiapine fumaratequetiapine fumarateGolden State Medical Supply, Inc.ANDACurrent
60429-418quetiapine fumaratequetiapine fumarateGolden State Medical Supply, Inc.ANDACurrent
60505-3130quetiapine fumaratequetiapine fumarateApotex Corp.ANDACurrent
60505-3130quetiapine fumaratequetiapine fumarateApotex Corp.ANDACurrent
60505-3131quetiapine fumaratequetiapine fumarateApotex Corp.ANDACurrent
60505-3132quetiapine fumaratequetiapine fumarateApotex Corp.ANDACurrent
60505-3132quetiapine fumaratequetiapine fumarateApotex Corp.ANDACurrent
60505-3133quetiapine fumaratequetiapine fumarateApotex Corp.ANDACurrent
60505-3133quetiapine fumaratequetiapine fumarateApotex Corp.ANDACurrent
60505-3134quetiapine fumaratequetiapine fumarateApotex Corp.ANDACurrent
60505-3135quetiapine fumaratequetiapine fumarateApotex Corp.ANDACurrent
60505-3135quetiapine fumaratequetiapine fumarateApotex Corp.ANDACurrent
60505-3136quetiapine fumaratequetiapine fumarateApotex Corp.ANDACurrent
60505-3137quetiapine fumaratequetiapine fumarateApotex Corp.ANDACurrent
60505-3137quetiapine fumaratequetiapine fumarateApotex Corp.ANDACurrent
60505-3138quetiapine fumaratequetiapine fumarateApotex Corp.ANDACurrent
60505-3139quetiapine fumaratequetiapine fumarateApotex Corp.ANDACurrent
60505-3139quetiapine fumaratequetiapine fumarateApotex Corp.ANDACurrent
70518-0753quetiapine fumaratequetiapine fumarateREMEDYREPACK INC.ANDACurrent
70518-0753quetiapine fumaratequetiapine fumarateREMEDYREPACK INC.ANDACurrent
70518-1029quetiapine fumaratequetiapine fumarateREMEDYREPACK INC.ANDACurrent
70518-1029quetiapine fumaratequetiapine fumarateREMEDYREPACK INC.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
31508ORIG2012-03-29