FDA.reportPublic FDA data

Application 078552

Type
ANDA
Sponsor
EPIC PHARMA LLC

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
10135-524Amlodipine BesylateAmlodipine BesylateMarlex Pharmaceuticals IncANDACurrent
10135-525Amlodipine BesylateAmlodipine BesylateMarlex Pharmaceuticals IncANDACurrent
10135-526Amlodipine BesylateAmlodipine BesylateMarlex Pharmaceuticals IncANDACurrent
42806-055AMLODIPINE BESYLATEAMLODIPINE BESYLATEEpic Pharma, LLCANDACurrent
42806-055AMLODIPINE BESYLATEAMLODIPINE BESYLATEEpic Pharma, LLCANDACurrent
42806-056AMLODIPINE BESYLATEAMLODIPINE BESYLATEEpic Pharma, LLCANDACurrent
42806-056AMLODIPINE BESYLATEAMLODIPINE BESYLATEEpic Pharma, LLCANDACurrent
42806-057AMLODIPINE BESYLATEAMLODIPINE BESYLATEEpic Pharma, LLCANDACurrent
42806-057AMLODIPINE BESYLATEAMLODIPINE BESYLATEEpic Pharma, LLCANDACurrent
50268-083AMLODIPINE BESYLATEAMLODIPINE BESYLATEAvPAKANDACurrent
50268-084AMLODIPINE BESYLATEAMLODIPINE BESYLATEAvPAKANDACurrent
50268-084AMLODIPINE BESYLATEAMLODIPINE BESYLATEAvPAKANDACurrent
50268-085AMLODIPINE BESYLATEAMLODIPINE BESYLATEAvPAKANDACurrent
50268-085AMLODIPINE BESYLATEAMLODIPINE BESYLATEAvPAKANDACurrent
53808-1100AMLODIPINE BESYLATEAMLODIPINE BESYLATEDOH CENTRAL PHARMACYANDACurrent
55154-4331Amlodipine BesylateAmlodipine BesylateCardinal HealthANDACurrent
55154-4331Amlodipine BesylateAmlodipine BesylateCardinal HealthANDACurrent
55154-4331AMLODIPINE BESYLATEAMLODIPINE BESYLATECardinal HealthANDACurrent
57664-055Amlodipine BesylateAMLODIPINE BESYLATECaraco Pharmaceutical Laboratories, Ltd.ANDACurrent
57664-056Amlodipine BesylateAMLODIPINE BESYLATECaraco Pharmaceutical Laboratories, Ltd.ANDACurrent
57664-057Amlodipine BesylateAMLODIPINE BESYLATECaraco Pharmaceutical Laboratories, Ltd.ANDACurrent
68071-3327AMLODIPINE BESYLATEAMLODIPINE BESYLATENuCare Pharmaceuticals, Inc.ANDACurrent
68645-580AMLODIPINE BESYLATEAMLODIPINE BESYLATELegacy Pharmaceutical Packaging, LLCANDACurrent
68645-580AMLODIPINE BESYLATEAMLODIPINE BESYLATELegacy Pharmaceutical Packaging, LLCANDACurrent
68645-580AMLODIPINE BESYLATEAMLODIPINE BESYLATELegacy Pharmaceutical Packaging, LLCANDACurrent
70518-1622AMLODIPINE BESYLATEAMLODIPINE BESYLATEREMEDYREPACK INC.ANDACurrent
70518-1622AMLODIPINE BESYLATEAMLODIPINE BESYLATEREMEDYREPACK INC.ANDACurrent
70518-1677AMLODIPINE BESYLATEAMLODIPINE BESYLATEREMEDYREPACK INC.ANDACurrent
70518-1677AMLODIPINE BESYLATEAMLODIPINE BESYLATEREMEDYREPACK INC.ANDACurrent
70934-288AMLODIPINE BESYLATEAMLODIPINE BESYLATEDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-288AMLODIPINE BESYLATEAMLODIPINE BESYLATEDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-288AMLODIPINE BESYLATEAMLODIPINE BESYLATEDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
71610-620AMLODIPINE BESYLATEAMLODIPINE BESYLATEAphena Pharma Solutions - Tennessee, LLCANDACurrent