FDA.reportPublic FDA data

Application 203150

Type
ANDA
Sponsor
JUBILANT GENERICS

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
59746-348Quetiapine fumarateQuetiapine fumarateJubilant Cadista Pharmaceuticals Inc.ANDACurrent
59746-348Quetiapine fumarateQuetiapine fumarateJubilant Cadista Pharmaceuticals Inc.ANDACurrent
59746-348Quetiapine fumarateQuetiapine fumarateJubilant Cadista Pharmaceuticals Inc.ANDACurrent