FDA.reportPublic FDA data

Application 078226

Type
ANDA
Sponsor
ZYDUS PHARMS USA

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
0904-6369Amlodipine BesylateAmlodipine BesylateMajor PharmaceuticalsANDACurrent
0904-6369Amlodipine BesylateAmlodipine BesylateMajor PharmaceuticalsANDACurrent
0904-6370Amlodipine BesylateAmlodipine BesylateMajor PharmaceuticalsANDACurrent
0904-6370Amlodipine BesylateAmlodipine BesylateMajor PharmaceuticalsANDACurrent
0904-6371Amlodipine BesylateAmlodipine BesylateMajor PharmaceuticalsANDACurrent
0904-6371Amlodipine BesylateAmlodipine BesylateMajor PharmaceuticalsANDACurrent
50090-5049Amlodipine BesylateAmlodipine BesylateA-S Medication SolutionsANDACurrent
55154-6875Amlodipine BesylateAmlodipine BesylateCardinal Health, Inc.ANDACurrent
55154-6875Amlodipine BesylateAmlodipine BesylateCardinal Health, Inc.ANDACurrent
55154-6875Amlodipine BesylateAmlodipine BesylateCardinal Health, Inc.ANDACurrent
55154-6875Amlodipine BesylateAmlodipine BesylateCardinal Health 107, LLCANDACurrent
55154-6892Amlodipine BesylateAmlodipine BesylateCardinal Health, Inc.ANDACurrent
55154-6892Amlodipine BesylateAmlodipine BesylateCardinal Health 107, LLCANDACurrent
55154-6892Amlodipine BesylateAmlodipine BesylateCardinal Health, Inc.ANDACurrent
55154-6892Amlodipine BesylateAmlodipine BesylateCardinal Health, Inc.ANDACurrent
55154-8093Amlodipine BesylateAmlodipine BesylateCardinal Health, Inc.ANDACurrent
55154-8093Amlodipine BesylateAmlodipine BesylateCardinal Health 107, LLCANDACurrent
63739-631Amlodipine BesylateAmlodipine BesylateMcKesson Corporation dba SKY PackagingANDACurrent
63739-631Amlodipine BesylateAmlodipine BesylateMcKesson Corporation dba SKY PackagingANDACurrent
63739-631Amlodipine BesylateAmlodipine BesylateMcKesson CorporationANDACurrent
65841-620Amlodipine BesylateAmlodipine BesylateCadila Healthcare LimitedANDACurrent
65841-620Amlodipine BesylateAmlodipine BesylateCadila Healthcare LimitedANDACurrent
65841-620Amlodipine BesylateAmlodipine BesylateZydus Lifesciences LimitedANDACurrent
65841-620Amlodipine BesylateAmlodipine BesylateCadila Healthcare LimitedANDACurrent
65841-621Amlodipine BesylateAmlodipine BesylateZydus Lifesciences LimitedANDACurrent
65841-621Amlodipine BesylateAmlodipine BesylateCadila Healthcare LimitedANDACurrent
65841-621Amlodipine BesylateAmlodipine BesylateCadila Healthcare LimitedANDACurrent
65841-621Amlodipine BesylateAmlodipine BesylateCadila Healthcare LimitedANDACurrent
65841-622Amlodipine BesylateAmlodipine BesylateZydus Lifesciences LimitedANDACurrent
65841-622Amlodipine BesylateAmlodipine BesylateCadila Healthcare LimitedANDACurrent
65841-622Amlodipine BesylateAmlodipine BesylateCadila Healthcare LimitedANDACurrent
65841-622Amlodipine BesylateAmlodipine BesylateCadila Healthcare LimitedANDACurrent
68382-121Amlodipine BesylateAmlodipine BesylateZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-121Amlodipine BesylateAmlodipine BesylateZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-121Amlodipine BesylateAmlodipine BesylateZydus Pharmaceuticals USA Inc.ANDACurrent
68382-122Amlodipine BesylateAmlodipine BesylateZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-122Amlodipine BesylateAmlodipine BesylateZydus Pharmaceuticals USA Inc.ANDACurrent
68382-122Amlodipine BesylateAmlodipine BesylateZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-123Amlodipine BesylateAmlodipine BesylateZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-123Amlodipine BesylateAmlodipine BesylateZydus Pharmaceuticals USA Inc.ANDACurrent
68382-123Amlodipine BesylateAmlodipine BesylateZydus Pharmaceuticals (USA) Inc.ANDACurrent
76413-141Amlodipine BesylateAmlodipine BesylateCentral Texas Community Health CentersANDACurrent