FDA.reportPublic FDA data

Application 078477

Type
ANDA
Sponsor
AMNEAL PHARMS NY

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
58517-120AMLODIPINE BESYLATEAMLODIPINE BESYLATENew Horizon Rx Group, LLCANDACurrent
65162-006Amlodipine BesylateAmlodipine BesylateAmneal Pharmaceuticals LLCANDACurrent
65162-006Amlodipine BesylateAmlodipine BesylateAmneal Pharmaceuticals LLCANDACurrent
65162-006Amlodipine BesylateAmlodipine BesylateAmneal Pharmaceuticals LLCANDACurrent
65162-006Amlodipine BesylateAmlodipine BesylateAmneal Pharmaceuticals LLCANDACurrent
65162-007Amlodipine BesylateAmlodipine BesylateAmneal Pharmaceuticals LLCANDACurrent
65162-007Amlodipine BesylateAmlodipine BesylateAmneal Pharmaceuticals LLCANDACurrent
65162-007Amlodipine BesylateAmlodipine BesylateAmneal Pharmaceuticals LLCANDACurrent
65162-007Amlodipine BesylateAmlodipine BesylateAmneal Pharmaceuticals LLCANDACurrent
65162-008Amlodipine BesylateAmlodipine BesylateAmneal Pharmaceuticals LLCANDACurrent
65162-008Amlodipine BesylateAmlodipine BesylateAmneal Pharmaceuticals LLCANDACurrent
65162-008Amlodipine BesylateAmlodipine BesylateAmneal Pharmaceuticals LLCANDACurrent
65162-008Amlodipine BesylateAmlodipine BesylateAmneal Pharmaceuticals LLCANDACurrent