FDA.reportPublic FDA data

Application 077516

Type
ANDA
Sponsor
STRIDES PHARMA

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
0615-8282AMLODIPINE BESYLATEAMLODIPINE BESYLATENCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
0615-8282AMLODIPINE BESYLATEAMLODIPINE BESYLATENCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8282AMLODIPINE BESYLATEAMLODIPINE BESYLATENCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8283AMLODIPINE BESYLATEAMLODIPINE BESYLATENCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8283AMLODIPINE BESYLATEAMLODIPINE BESYLATENCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
0615-8283AMLODIPINE BESYLATEAMLODIPINE BESYLATENCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8284AMLODIPINE BESYLATEAMLODIPINE BESYLATENCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8284AMLODIPINE BESYLATEAMLODIPINE BESYLATENCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
0615-8284AMLODIPINE BESYLATEAMLODIPINE BESYLATENCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
42582-313AMLODIPINE BESYLATEAMLODIPINE BESYLATEBi-Coastal Pharma International LLCANDACurrent
42582-314AMLODIPINE BESYLATEAMLODIPINE BESYLATEBi-Coastal Pharma International LLCANDACurrent
42582-315AMLODIPINE BESYLATEAMLODIPINE BESYLATEBi-Coastal Pharma International LLCANDACurrent
55700-740AMLODIPINE BESYLATEAMLODIPINE BESYLATEQuality Care Products, LLCANDACurrent
62980-506AMLODIPINE BESYLATEAMLODIPINE BESYLATEVivimed Labs LimitedANDACurrent
62980-507AMLODIPINE BESYLATEAMLODIPINE BESYLATEVivimed Labs LimitedANDACurrent
62980-508AMLODIPINE BESYLATEAMLODIPINE BESYLATEVivimed Labs LimitedANDACurrent
69150-113Amlodipine BesylateAmlodipine BesylateBIOMES PHARMACEUTICALS LLCANDACurrent
69150-113Amlodipine BesylateAmlodipine BesylateBIOMES PHARMACEUTICALS LLCANDACurrent
69150-114Amlodipine BesylateAmlodipine BesylateBIOMES PHARMACEUTICALS LLCANDACurrent
69150-114Amlodipine BesylateAmlodipine BesylateBIOMES PHARMACEUTICALS LLCANDACurrent
69150-115Amlodipine BesylateAmlodipine BesylateBIOMES PHARMACEUTICALS LLCANDACurrent
69150-115Amlodipine BesylateAmlodipine BesylateBIOMES PHARMACEUTICALS LLCANDACurrent
71093-146AMLODIPINE BESYLATEAMLODIPINE BESYLATEACI Healthcare USA, Inc.ANDACurrent
71093-146AMLODIPINE BESYLATEAMLODIPINE BESYLATEACI Healthcare USA, Inc.ANDACurrent
71093-146AMLODIPINE BESYLATEAMLODIPINE BESYLATEACI Healthcare USA, Inc.ANDACurrent
71093-146AMLODIPINE BESYLATEAMLODIPINE BESYLATEACI Healthcare USA, Inc.ANDACurrent
71093-146AMLODIPINE BESYLATEAMLODIPINE BESYLATEACI Healthcare USA, Inc.ANDACurrent
71093-147AMLODIPINE BESYLATEAMLODIPINE BESYLATEACI Healthcare USA, Inc.ANDACurrent
71093-147AMLODIPINE BESYLATEAMLODIPINE BESYLATEACI Healthcare USA, Inc.ANDACurrent
71093-147AMLODIPINE BESYLATEAMLODIPINE BESYLATEACI Healthcare USA, Inc.ANDACurrent
71093-147AMLODIPINE BESYLATEAMLODIPINE BESYLATEACI Healthcare USA, Inc.ANDACurrent
71093-147AMLODIPINE BESYLATEAMLODIPINE BESYLATEACI Healthcare USA, Inc.ANDACurrent
71093-148AMLODIPINE BESYLATEAMLODIPINE BESYLATEACI Healthcare USA, Inc.ANDACurrent
71093-148AMLODIPINE BESYLATEAMLODIPINE BESYLATEACI Healthcare USA, Inc.ANDACurrent
71093-148AMLODIPINE BESYLATEAMLODIPINE BESYLATEACI Healthcare USA, Inc.ANDACurrent
71093-148AMLODIPINE BESYLATEAMLODIPINE BESYLATEACI Healthcare USA, Inc.ANDACurrent
71093-148AMLODIPINE BESYLATEAMLODIPINE BESYLATEACI Healthcare USA, Inc.ANDACurrent
71335-1887AMLODIPINE BESYLATEAMLODIPINE BESYLATEBryant Ranch PrepackANDACurrent
71335-1887AMLODIPINE BESYLATEAMLODIPINE BESYLATEBryant Ranch PrepackANDACurrent