FDA.reportPublic FDA data

Application 077771

Type
ANDA
Sponsor
HIKMA PHARMS

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
0143-9959Amlodipine besylateAmlodipine besylateHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9959Amlodipine besylateAmlodipine besylateWest-Ward Pharmaceuticals CorpANDACurrent
0143-9959Amlodipine besylateAmlodipine besylateHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9960Amlodipine besylateAmlodipine besylateHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9960Amlodipine besylateAmlodipine besylateWest-Ward Pharmaceuticals CorpANDACurrent
0143-9960Amlodipine besylateAmlodipine besylateHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9961Amlodipine besylateAmlodipine besylateHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9961Amlodipine besylateAmlodipine besylateWest-Ward Pharmaceuticals CorpANDACurrent
0143-9961Amlodipine besylateAmlodipine besylateHikma Pharmaceuticals USA Inc.ANDACurrent
59115-056Amlodipine besylateAmlodipine besylateHikma PharmaceuticalANDACurrent
59115-057Amlodipine besylateAmlodipine besylateHikma PharmaceuticalANDACurrent
59115-058Amlodipine besylateAmlodipine besylateHikma PharmaceuticalANDACurrent