FDA.reportPublic FDA data

Application 076846

Type
ANDA
Sponsor
TEVA

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
0093-0083Amlodipine BesylateAmlodipine BesylateTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7167Amlodipine BesylateAmlodipine BesylateTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7168Amlodipine BesylateAmlodipine BesylateTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7168Amlodipine BesylateAmlodipine BesylateTeva Pharmaceuticals USA, Inc.ANDACurrent
0480-0083Amlodipine BesylateAmlodipine BesylateTeva Pharmaceuticals, Inc.ANDACurrent
0480-0083Amlodipine BesylateAmlodipine BesylateTeva Pharmaceuticals, Inc.ANDACurrent
0480-7167Amlodipine BesylateAmlodipine BesylateTeva Pharmaceuticals, Inc.ANDACurrent
0480-7167Amlodipine BesylateAmlodipine BesylateTeva Pharmaceuticals, Inc.ANDACurrent
0480-7168Amlodipine BesylateAmlodipine BesylateTeva Pharmaceuticals, Inc.ANDACurrent
0480-7168Amlodipine BesylateAmlodipine BesylateTeva Pharmaceuticals, Inc.ANDACurrent
42708-008Amlodipine BesylateAmlodipine BesylateQPharma IncANDACurrent
42708-008Amlodipine BesylateAmlodipine BesylateQPharma IncANDACurrent
66116-446Amlodipine BesylateAmlodipine BesylateMedVantx, Inc.ANDACurrent