FDA.reportPublic FDA data

Application 078466

Type
ANDA
Sponsor
LUPIN PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEAMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDECAPSULE;ORALEQ 2.5MG BASE;10MGNoNo
002AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEAMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDECAPSULE;ORALEQ 5MG BASE;10MGNoNo
003AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEAMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDECAPSULE;ORALEQ 5MG BASE;20MGNoNo
004AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEAMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDECAPSULE;ORALEQ 10MG BASE;20MGNoNo
005AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEAMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDECAPSULE;ORALEQ 5MG BASE;40MGNoNo
006AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEAMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDECAPSULE;ORALEQ 10MG BASE;40MGNoNo
007AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDEAMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDECAPSULE; ORAL10MG; 40MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
43063-571Amlodipine Besylate and Benazepril HydrochlorideAmlodipine Besylate and Benazepril HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-571Amlodipine Besylate and Benazepril HydrochlorideAmlodipine Besylate and Benazepril HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
50090-5357Amlodipine Besylate and Benazepril HydrochlorideAmlodipine Besylate and Benazepril HydrochlorideA-S Medication SolutionsANDACurrent
50090-5389Amlodipine Besylate and Benazepril HydrochlorideAmlodipine Besylate and Benazepril HydrochlorideA-S Medication SolutionsANDACurrent
50090-5404Amlodipine Besylate and Benazepril HydrochlorideAmlodipine Besylate and Benazepril HydrochlorideA-S Medication SolutionsANDACurrent
50090-6185Amlodipine Besylate and Benazepril HydrochlorideAmlodipine Besylate and Benazepril HydrochlorideA-S Medication SolutionsANDACurrent
68001-130Amlodipine Besylate and Benazepril HydrochlorideAmlodipine Besylate and Benazepril HydrochlorideBluePoint LaboratoriesANDACurrent
68001-130Amlodipine Besylate and Benazepril HydrochlorideAmlodipine Besylate and Benazepril HydrochlorideBluePoint LaboratoriesANDACurrent
68001-130Amlodipine Besylate and Benazepril HydrochlorideAmlodipine Besylate and Benazepril HydrochlorideBluePoint LaboratoriesANDACurrent
68001-130Amlodipine Besylate and Benazepril HydrochlorideAmlodipine Besylate and Benazepril HydrochlorideBluePoint LaboratoriesANDACurrent
68001-131Amlodipine Besylate and Benazepril HydrochlorideAmlodipine Besylate and Benazepril HydrochlorideBluePoint LaboratoriesANDACurrent
68001-131Amlodipine Besylate and Benazepril HydrochlorideAmlodipine Besylate and Benazepril HydrochlorideBluePoint LaboratoriesANDACurrent
68001-131Amlodipine Besylate and Benazepril HydrochlorideAmlodipine Besylate and Benazepril HydrochlorideBluePoint LaboratoriesANDACurrent
68001-131Amlodipine Besylate and Benazepril HydrochlorideAmlodipine Besylate and Benazepril HydrochlorideBluePoint LaboratoriesANDACurrent
68001-132Amlodipine Besylate and Benazepril HydrochlorideAmlodipine Besylate and Benazepril HydrochlorideBluePoint LaboratoriesANDACurrent
68001-132Amlodipine Besylate and Benazepril HydrochlorideAmlodipine Besylate and Benazepril HydrochlorideBluePoint LaboratoriesANDACurrent
68001-132Amlodipine Besylate and Benazepril HydrochlorideAmlodipine Besylate and Benazepril HydrochlorideBluePoint LaboratoriesANDACurrent
68001-132Amlodipine Besylate and Benazepril HydrochlorideAmlodipine Besylate and Benazepril HydrochlorideBluePoint LaboratoriesANDACurrent
68001-133Amlodipine Besylate and Benazepril HydrochlorideAmlodipine Besylate and Benazepril HydrochlorideBluePoint LaboratoriesANDACurrent
68001-133Amlodipine Besylate and Benazepril HydrochlorideAmlodipine Besylate and Benazepril HydrochlorideBluePoint LaboratoriesANDACurrent
68001-133Amlodipine Besylate and Benazepril HydrochlorideAmlodipine Besylate and Benazepril HydrochlorideBluePoint LaboratoriesANDACurrent
68001-133Amlodipine Besylate and Benazepril HydrochlorideAmlodipine Besylate and Benazepril HydrochlorideBluePoint LaboratoriesANDACurrent
68001-134Amlodipine Besylate and Benazepril HydrochlorideAmlodipine Besylate and Benazepril HydrochlorideBluePoint LaboratoriesANDACurrent
68001-134Amlodipine Besylate and Benazepril HydrochlorideAmlodipine Besylate and Benazepril HydrochlorideBluePoint LaboratoriesANDACurrent
68001-134Amlodipine Besylate and Benazepril HydrochlorideAmlodipine Besylate and Benazepril HydrochlorideBluePoint LaboratoriesANDACurrent
68001-134Amlodipine Besylate and Benazepril HydrochlorideAmlodipine Besylate and Benazepril HydrochlorideBluePoint LaboratoriesANDACurrent
68001-135Amlodipine Besylate and Benazepril HydrochlorideAmlodipine Besylate and Benazepril HydrochlorideBluePoint LaboratoriesANDACurrent
68001-135Amlodipine Besylate and Benazepril HydrochlorideAmlodipine Besylate and Benazepril HydrochlorideBluePoint LaboratoriesANDACurrent
68001-135Amlodipine Besylate and Benazepril HydrochlorideAmlodipine Besylate and Benazepril HydrochlorideBluePoint LaboratoriesANDACurrent
68001-135Amlodipine Besylate and Benazepril HydrochlorideAmlodipine Besylate and Benazepril HydrochlorideBluePoint LaboratoriesANDACurrent
68151-1364Amlodipine Besylate and Benazepril HydrochlorideAmlodipine Besylate and Benazepril HydrochlorideCarilion Materials ManagementANDACurrent
68180-459Amlodipine Besylate and Benazepril HydrochlorideAmlodipine Besylate and Benazepril HydrochlorideLupin Pharmaceuticals, Inc.ANDACurrent
68180-459Amlodipine Besylate and Benazepril HydrochlorideAmlodipine Besylate and Benazepril HydrochlorideLupin Pharmaceuticals, Inc.ANDACurrent
68180-459Amlodipine Besylate and Benazepril HydrochlorideAmlodipine Besylate and Benazepril HydrochlorideLupin Pharmaceuticals, Inc.ANDACurrent
68180-459Amlodipine Besylate and Benazepril HydrochlorideAmlodipine Besylate and Benazepril HydrochlorideLupin Pharmaceuticals, Inc.ANDACurrent
68180-463Amlodipine Besylate and Benazepril HydrochlorideAmlodipine Besylate and Benazepril HydrochlorideLupin Pharmaceuticals, Inc.ANDACurrent
68180-463Amlodipine Besylate and Benazepril HydrochlorideAmlodipine Besylate and Benazepril HydrochlorideLupin Pharmaceuticals, Inc.ANDACurrent
68180-463Amlodipine Besylate and Benazepril HydrochlorideAmlodipine Besylate and Benazepril HydrochlorideLupin Pharmaceuticals, Inc.ANDACurrent
68180-463Amlodipine Besylate and Benazepril HydrochlorideAmlodipine Besylate and Benazepril HydrochlorideLupin Pharmaceuticals, Inc.ANDACurrent
68180-472Amlodipine Besylate and Benazepril HydrochlorideAmlodipine Besylate and Benazepril HydrochlorideLupin Pharmaceuticals, Inc.ANDACurrent
68180-472Amlodipine Besylate and Benazepril HydrochlorideAmlodipine Besylate and Benazepril HydrochlorideLupin Pharmaceuticals, Inc.ANDACurrent
68180-472Amlodipine Besylate and Benazepril HydrochlorideAmlodipine Besylate and Benazepril HydrochlorideLupin Pharmaceuticals, Inc.ANDACurrent
68180-472Amlodipine Besylate and Benazepril HydrochlorideAmlodipine Besylate and Benazepril HydrochlorideLupin Pharmaceuticals, Inc.ANDACurrent
68180-473Amlodipine Besylate and Benazepril HydrochlorideAmlodipine Besylate and Benazepril HydrochlorideLupin Pharmaceuticals, Inc.ANDACurrent
68180-473Amlodipine Besylate and Benazepril HydrochlorideAmlodipine Besylate and Benazepril HydrochlorideLupin Pharmaceuticals, Inc.ANDACurrent
68180-473Amlodipine Besylate and Benazepril HydrochlorideAmlodipine Besylate and Benazepril HydrochlorideLupin Pharmaceuticals, Inc.ANDACurrent
68180-473Amlodipine Besylate and Benazepril HydrochlorideAmlodipine Besylate and Benazepril HydrochlorideLupin Pharmaceuticals, Inc.ANDACurrent
68180-755Amlodipine Besylate and Benazepril HydrochlorideAmlodipine Besylate and Benazepril HydrochlorideLupin Pharmaceuticals, Inc.ANDACurrent
68180-755Amlodipine Besylate and Benazepril HydrochlorideAmlodipine Besylate and Benazepril HydrochlorideLupin Pharmaceuticals, Inc.ANDACurrent
68180-755Amlodipine Besylate and Benazepril HydrochlorideAmlodipine Besylate and Benazepril HydrochlorideLupin Pharmaceuticals, Inc.ANDACurrent
68180-755Amlodipine Besylate and Benazepril HydrochlorideAmlodipine Besylate and Benazepril HydrochlorideLupin Pharmaceuticals, Inc.ANDACurrent
68180-756Amlodipine Besylate and Benazepril HydrochlorideAmlodipine Besylate and Benazepril HydrochlorideLupin Pharmaceuticals, Inc.ANDACurrent
68180-756Amlodipine Besylate and Benazepril HydrochlorideAmlodipine Besylate and Benazepril HydrochlorideLupin Pharmaceuticals, Inc.ANDACurrent
68180-756Amlodipine Besylate and Benazepril HydrochlorideAmlodipine Besylate and Benazepril HydrochlorideLupin Pharmaceuticals, Inc.ANDACurrent
68180-756Amlodipine Besylate and Benazepril HydrochlorideAmlodipine Besylate and Benazepril HydrochlorideLupin Pharmaceuticals, Inc.ANDACurrent
68180-757Amlodipine Besylate and Benazepril HydrochlorideAmlodipine Besylate and Benazepril HydrochlorideLupin Pharmaceuticals, Inc.ANDACurrent
68180-757Amlodipine Besylate and Benazepril HydrochlorideAmlodipine Besylate and Benazepril HydrochlorideLupin Pharmaceuticals, Inc.ANDACurrent
68180-758Amlodipine Besylate and Benazepril HydrochlorideAmlodipine Besylate and Benazepril HydrochlorideLupin Pharmaceuticals, Inc.ANDACurrent
68180-759Amlodipine Besylate and Benazepril HydrochlorideAmlodipine Besylate and Benazepril HydrochlorideLupin Pharmaceuticals, Inc.ANDACurrent
68180-759Amlodipine Besylate and Benazepril HydrochlorideAmlodipine Besylate and Benazepril HydrochlorideLupin Pharmaceuticals, Inc.ANDACurrent
68180-760Amlodipine Besylate and Benazepril HydrochlorideAmlodipine Besylate and Benazepril HydrochlorideLupin Pharmaceuticals, Inc.ANDACurrent
68180-760Amlodipine Besylate and Benazepril HydrochlorideAmlodipine Besylate and Benazepril HydrochlorideLupin Pharmaceuticals, Inc.ANDACurrent
70518-2566Amlodipine Besylate and Benazepril HydrochlorideAmlodipine Besylate and Benazepril HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2566Amlodipine Besylate and Benazepril HydrochlorideAmlodipine Besylate and Benazepril HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-3030Amlodipine Besylate and Benazepril HydrochlorideAmlodipine Besylate and Benazepril HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-3303Amlodipine Besylate and Benazepril HydrochlorideAmlodipine Besylate and Benazepril HydrochlorideREMEDYREPACK INC.ANDACurrent
70934-560Amlodipine Besylate and Benazepril HydrochlorideAmlodipine Besylate and Benazepril HydrochlorideDenton Pharma, Inc. dba Northwind PharmaceuticalsANDACurrent
70934-637Amlodipine Besylate and Benazepril HydrochlorideAmlodipine Besylate and Benazepril HydrochlorideDenton Pharma, Inc. dba Northwind PharmaceuticalsANDACurrent
71335-1946Amlodipine Besylate and Benazepril HydrochlorideAmlodipine Besylate and Benazepril HydrochlorideBryant Ranch PrepackANDACurrent