FDA.reportPublic FDA data

Application 215560

Type
ANDA
Sponsor
NOVITIUM PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ATENOLOL AND CHLORTHALIDONEATENOLOL; CHLORTHALIDONETABLET;ORAL50MG;25MGNoNo
002ATENOLOL AND CHLORTHALIDONEATENOLOL; CHLORTHALIDONETABLET;ORAL100MG;25MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
10135-733ATENOLOL AND CHLORTHALIDONEatenolol and chlorthalidone tabletMARLEX PHARMACEUTICALS, INCANDACurrent
10135-734ATENOLOL AND CHLORTHALIDONEatenolol and chlorthalidone tabletMARLEX PHARMACEUTICALS, INCANDACurrent
70518-3550Atenolol and ChlorthalidoneAtenolol and ChlorthalidoneREMEDYREPACK INC.ANDACurrent
70954-390Atenolol and ChlorthalidoneAtenolol and ChlorthalidoneNovitium Pharma LLCANDACurrent
70954-391Atenolol and ChlorthalidoneAtenolol and ChlorthalidoneNovitium Pharma LLCANDACurrent