FDA.reportPublic FDA data

Application 077262

Type
ANDA
Sponsor
HIKMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AMLODIPINE BESYLATEAMLODIPINE BESYLATETABLET;ORALEQ 2.5MG BASENoNo
002AMLODIPINE BESYLATEAMLODIPINE BESYLATETABLET;ORALEQ 5MG BASENoNo
003AMLODIPINE BESYLATEAMLODIPINE BESYLATETABLET;ORALEQ 10MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0054-0100Amlodipine BesylateAmlodipine BesylateWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-0100Amlodipine BesylateAmlodipine BesylateWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-0101Amlodipine BesylateAmlodipine BesylateWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-0101Amlodipine BesylateAmlodipine BesylateWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-0102Amlodipine BesylateAmlodipine BesylateWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-0102Amlodipine BesylateAmlodipine BesylateWest-Ward Pharmaceuticals Corp.ANDACurrent
53808-0340Amlodipine BesylateAmlodipine BesylateState of Florida DOH Central PharmacyANDACurrent
63629-6362Amlodipine BesylateAmlodipine BesylateBryant Ranch PrepackANDACurrent
63629-6632Amlodipine BesylateAmlodipine BesylateBryant Ranch PrepackANDACurrent