FDA.reportPublic FDA data

Application 203534

Type
ANDA
Sponsor
JUBILANT GENERICS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001IRBESARTANIRBESARTANTABLET;ORAL75MGNoNo
002IRBESARTANIRBESARTANTABLET;ORAL150MGNoNo
003IRBESARTANIRBESARTANTABLET;ORAL300MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50090-3244IRBESARTANIRBESARTANA-S Medication SolutionsANDACurrent
50090-3244IRBESARTANIRBESARTANA-S Medication SolutionsANDACurrent
50090-3244IRBESARTANIRBESARTANA-S Medication SolutionsANDACurrent
50090-3269IRBESARTANIRBESARTANA-S Medication SolutionsANDACurrent
50090-3269IRBESARTANIRBESARTANA-S Medication SolutionsANDACurrent
50090-3269IRBESARTANIRBESARTANA-S Medication SolutionsANDACurrent
59746-447IRBESARTANIRBESARTANJubilant Cadista PharmaceANDACurrent
59746-447IRBESARTANIRBESARTANJubilant Cadista Pharmaceuticals Inc.ANDACurrent
59746-447IRBESARTANIRBESARTANJubilant Cadista Pharmaceuticals Inc.ANDACurrent
59746-447IRBESARTANIRBESARTANJubilant Cadista Pharmaceuticals Inc.ANDACurrent
59746-448IRBESARTANIRBESARTANJubilant Cadista Pharmaceuticals Inc.ANDACurrent
59746-448IRBESARTANIRBESARTANJubilant Cadista Pharmaceuticals Inc.ANDACurrent
59746-448IRBESARTANIRBESARTANJubilant Cadista Pharmaceuticals Inc.ANDACurrent
59746-448IRBESARTANIRBESARTANJubilant Cadista PharmaceANDACurrent
59746-449IRBESARTANIRBESARTANJubilant Cadista Pharmaceuticals Inc.ANDACurrent
59746-449IRBESARTANIRBESARTANJubilant Cadista Pharmaceuticals Inc.ANDACurrent
59746-449IRBESARTANIRBESARTANJubilant Cadista Pharmaceuticals Inc.ANDACurrent
59746-449IRBESARTANIRBESARTANJubilant Cadista PharmaceANDACurrent