FDA.reportPublic FDA data

Application 090120

Type
ANDA
Sponsor
HIKMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001QUETIAPINE FUMARATEQUETIAPINE FUMARATETABLET;ORALEQ 25MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0054-0220Quetiapine FumarateQuetiapine FumarateWest-Ward Pharmaceuticals CorpANDACurrent
0054-0220Quetiapine FumarateQuetiapine FumarateWest-Ward Pharmaceuticals CorpANDACurrent
0054-0220Quetiapine FumarateQuetiapine FumarateWest-Ward Pharmaceuticals CorpANDACurrent
0054-0220Quetiapine FumarateQuetiapine FumarateWest-Ward Pharmaceuticals CorpANDACurrent
0054-0220Quetiapine FumarateQuetiapine FumarateWest-Ward Pharmaceuticals CorpANDACurrent
0054-0220Quetiapine FumarateQuetiapine FumarateWest-Ward Pharmaceuticals CorpANDACurrent
0054-0220Quetiapine FumarateQuetiapine FumarateWest-Ward Pharmaceuticals CorpANDACurrent
0054-0220Quetiapine FumarateQuetiapine FumarateWest-Ward Pharmaceuticals CorpANDACurrent
0054-0220Quetiapine FumarateQuetiapine FumarateWest-Ward Pharmaceuticals CorpANDACurrent
43353-004Quetiapine FumarateQuetiapine FumarateAphena Pharma Solutions - Tennessee, LLCANDACurrent
43353-008Quetiapine FumarateQuetiapine FumarateAphena Pharma Solutions - Tennessee, LLCANDACurrent
43353-814Quetiapine FumarateQuetiapine FumarateAphena Pharma Solutions - Tennessee, LLCANDACurrent
43353-818Quetiapine FumarateQuetiapine FumarateAphena Pharma Solutions - Tennessee, LLCANDACurrent
51407-066Quetiapine FumarateQuetiapine FumarateGolden State Medical Supply Inc.ANDACurrent
51407-066Quetiapine FumarateQuetiapine FumarateGolden State Medical Supply Inc.ANDACurrent
51407-066Quetiapine FumarateQuetiapine FumarateGolden State Medical Supply Inc.ANDACurrent
51407-066Quetiapine FumarateQuetiapine FumarateGolden State Medical Supply, Inc.ANDACurrent
51407-066Quetiapine FumarateQuetiapine FumarateGolden State Medical SupplyANDACurrent
51407-066Quetiapine FumarateQuetiapine FumarateGolden State Medical Supply, Inc.ANDACurrent
51407-066Quetiapine FumarateQuetiapine FumarateGolden State Medical Supply, Inc.ANDACurrent
67296-1243Quetiapine FumarateQuetiapine FumarateRedPharm Drug, Inc.ANDACurrent
67296-1243Quetiapine FumarateQuetiapine FumarateRedPharm Drug, Inc.ANDACurrent
67296-1243Quetiapine FumarateQuetiapine FumarateRedPharm Drug, Inc.ANDACurrent
71610-140Quetiapine FumarateQuetiapine FumarateAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-140Quetiapine FumarateQuetiapine FumarateAphena Pharma Solutions - Tennessee, LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
31452ORIG2015-11-06
9258ORIG2012-03-30
9257ORIG2012-03-28