FDA.reportPublic FDA data

Application 203071

Type
ANDA
Sponsor
PRINSTON INC

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
43547-277IrbesartanIRBESARTANSolco healthcare U.S., LLCANDACurrent
43547-278IrbesartanIRBESARTANSolco healthcare U.S., LLCANDACurrent
43547-279IrbesartanIRBESARTANSolco healthcare U.S., LLCANDACurrent
43547-374IrbesartanIrbesartanSolco Healthcare U.S., LLCANDACurrent
43547-374IrbesartanIrbesartanSolco Healthcare U.S., LLCANDACurrent
43547-374IrbesartanIrbesartanSolco Healthcare U.S., LLCANDACurrent
43547-374IrbesartanIrbesartanSolco Healthcare U.S., LLCANDACurrent
43547-374IrbesartanIrbesartanSolco Healthcare U.S., LLCANDACurrent
43547-375IrbesartanIrbesartanSolco Healthcare U.S., LLCANDACurrent
43547-375IrbesartanIrbesartanSolco Healthcare U.S., LLCANDACurrent
43547-375IrbesartanIrbesartanSolco Healthcare U.S., LLCANDACurrent
43547-375IrbesartanIrbesartanSolco Healthcare U.S., LLCANDACurrent
43547-375IrbesartanIrbesartanSolco Healthcare U.S., LLCANDACurrent
43547-376IrbesartanIrbesartanSolco Healthcare U.S., LLCANDACurrent
43547-376IrbesartanIrbesartanSolco Healthcare U.S., LLCANDACurrent
43547-376IrbesartanIrbesartanSolco Healthcare U.S., LLCANDACurrent
43547-376IrbesartanIrbesartanSolco Healthcare U.S., LLCANDACurrent
43547-376IrbesartanIrbesartanSolco Healthcare U.S., LLCANDACurrent
50090-2642IrbesartanIRBESARTANA-S Medication SolutionsANDACurrent
50090-2978IrbesartanIrbesartanA-S Medication SolutionsANDACurrent
50090-2978IrbesartanIrbesartanA-S Medication SolutionsANDACurrent
63187-757IrbesartanIRBESARTANProficient Rx LPANDACurrent
63187-757IrbesartanIRBESARTANProficient Rx LPANDACurrent
70518-1543IrbesartanIrbesartanREMEDYREPACK INC.ANDACurrent
70518-1543IrbesartanIrbesartanREMEDYREPACK INC.ANDACurrent
70518-1690IrbesartanIrbesartanREMEDYREPACK INC.ANDACurrent
70518-1690IrbesartanIrbesartanREMEDYREPACK INC.ANDACurrent
71205-082IrbesartanIrbesartanProficient Rx LPANDACurrent
71205-082IrbesartanIrbesartanProficient Rx LPANDACurrent
71335-0071IrbesartanIrbesartanBryant Ranch PrepackANDACurrent
71335-0071IrbesartanIrbesartanBryant Ranch PrepackANDACurrent
71335-0071IrbesartanIrbesartanBryant Ranch PrepackANDACurrent
71335-2168IrbesartanIrbesartanBryant Ranch PrepackANDACurrent