FDA.reportPublic FDA data

Application 090364

Type
ANDA
Sponsor
WATSON LABS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEAMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDECAPSULE;ORALEQ 5MG BASE;40MGNoNo
002AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEAMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDECAPSULE;ORALEQ 10MG BASE;40MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0591-3761Amlodipine and Benazepril HydrochlorideAmlodipine and Benazepril HydrochlorideActavis Pharma, Inc.ANDACurrent
0591-3762Amlodipine and Benazepril HydrochlorideAmlodipine and Benazepril HydrochlorideActavis Pharma, Inc.ANDACurrent
50090-3404Amlodipine and Benazepril HydrochlorideAmlodipine and Benazepril HydrochlorideA-S Medication SolutionsANDACurrent
63187-370Amlodipine Besylate and Benazepril HydrochlorideAmlodipine Besylate and Benazepril HydrochlorideProficient Rx LPANDACurrent