FDA.reportPublic FDA data

Application 076418

Type
ANDA
Sponsor
MYLAN

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
0378-5208Amlodipine Besylateamlodipine besylateMylan Pharmaceuticals Inc.ANDACurrent
0378-5209Amlodipine Besylateamlodipine besylateMylan Pharmaceuticals Inc.ANDACurrent
0378-5210Amlodipine Besylateamlodipine besylateMylan Pharmaceuticals Inc.ANDACurrent
0615-6577Amlodipine Besylateamlodipine besylateNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-6578Amlodipine Besylateamlodipine besylateNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-6582Amlodipine BesylateAmlodipineNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
51079-450Amlodipine Besylateamlodipine besylateMylan Institutional Inc.ANDACurrent
51079-451Amlodipine Besylateamlodipine besylateMylan Institutional Inc.ANDACurrent
51079-452Amlodipine Besylateamlodipine besylateMylan Institutional Inc.ANDACurrent
53808-0653Amlodipine Besylateamlodipine besylateState of Florida DOH Central PharmacyANDACurrent
55154-5072Amlodipine BesylateAmlodipine BesylateCardinal HealthANDACurrent
55154-5072Amlodipine BesylateAmlodipine BesylateCardinal Health, Inc.ANDACurrent
55154-5097Amlodipine BesylateAmlodipine BesylateCardinal HealthANDACurrent
55154-5097Amlodipine BesylateAmlodipine BesylateCardinal Health, Inc.ANDACurrent
55154-5692Amlodipine BesylateAmlodipine BesylateCardinal HealthANDACurrent
55154-5692Amlodipine BesylateAmlodipine BesylateCardinal HealthANDACurrent
55154-5692Amlodipine BesylateAmlodipine BesylateCardinal Health, Inc.ANDACurrent
67544-979Amlodipine Besylateamlodipine besylateAphena Pharma Solutions - Tennessee, LLCANDACurrent
67544-993Amlodipine Besylateamlodipine besylateAphena Pharma Solutions - Tennessee, LLCANDACurrent