Application 078500

Type
ANDA
Sponsor
WOCKHARDT

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
55154-3392Amlodipine BesylateAmlodipine BesylateCardinal HealthANDACurrent
55648-421AMLODIPINE BESYLATEAMLODIPINE BESYLATEWOCKHARDT LIMITEDANDACurrent
55648-422AMLODIPINE BESYLATEAMLODIPINE BESYLATEWOCKHARDT LIMITEDANDACurrent
55648-423AMLODIPINE BESYLATEAMLODIPINE BESYLATEWOCKHARDT LIMITEDANDACurrent
64679-421Amlodipine BesylateAmlodipine BesylateWockhardt USA LLC.ANDACurrent
64679-422Amlodipine BesylateAmlodipine BesylateWockhardt USA LLC.ANDACurrent
64679-423Amlodipine BesylateAmlodipine BesylateWockhardt USA LLC.ANDACurrent