FDA.reportPublic FDA data

Application 077183

Type
ANDA
Sponsor
DR REDDYS LABS INC

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
21695-866AmlobenzAmlobenzRebel Distributors CorpANDACurrent
21695-916AmlobenzAmlobenzRebel Distributors CorpANDACurrent
33261-823Amlodipine Besylate and Benazepril HydrochlorideAmlodipine Besylate and Benazepril HydrochlorideAidarex Pharmaceuticals LLCANDACurrent
33261-824Amlodipine Besylate and Benazepril HydrochlorideAmlodipine Besylate and Benazepril HydrochlorideAidarex Pharmaceuticals LLCANDACurrent
33261-825Amlodipine Besylate and Benazepril HydrochlorideAmlodipine Besylate and Benazepril HydrochlorideAidarex Pharmaceuticals LLCANDACurrent
50090-1041Amlodipine Besylate and Benazepril HydrochlorideAmlodipine Besylate and Benazepril HydrochlorideA-S Medication SolutionsANDACurrent
50090-1041Amlodipine Besylate and Benazepril HydrochlorideAmlodipine Besylate and Benazepril HydrochlorideA-S Medication SolutionsANDACurrent
50090-5137Amlodipine Besylate and Benazepril HydrochlorideAmlodipine Besylate and Benazepril HydrochlorideA-S Medication SolutionsANDACurrent
55111-338Amlodipine Besylate and Benazepril HydrochlorideAmlodipine Besylate and Benazepril HydrochlorideDr.Reddy's Laboratories LimitedANDACurrent
55111-338Amlodipine Besylate and Benazepril HydrochlorideAmlodipine Besylate and Benazepril HydrochlorideDr.Reddy's Laboratories LimitedANDACurrent
55111-338Amlodipine Besylate and Benazepril HydrochlorideAmlodipine Besylate and Benazepril HydrochlorideDr.Reddy's Laboratories LimitedANDACurrent
55111-338Amlodipine Besylate and Benazepril HydrochlorideAmlodipine Besylate and Benazepril HydrochlorideDr.Reddy's Laboratories LimitedANDACurrent
55111-339Amlodipine Besylate and Benazepril HydrochlorideAmlodipine Besylate and Benazepril HydrochlorideDr.Reddy's Laboratories LimitedANDACurrent
55111-339Amlodipine Besylate and Benazepril HydrochlorideAmlodipine Besylate and Benazepril HydrochlorideDr.Reddy's Laboratories LimitedANDACurrent
55111-339Amlodipine Besylate and Benazepril HydrochlorideAmlodipine Besylate and Benazepril HydrochlorideDr.Reddy's Laboratories LimitedANDACurrent
55111-339Amlodipine Besylate and Benazepril HydrochlorideAmlodipine Besylate and Benazepril HydrochlorideDr.Reddy's Laboratories LimitedANDACurrent
55111-340Amlodipine Besylate and Benazepril HydrochlorideAmlodipine Besylate and Benazepril HydrochlorideDr.Reddy's Laboratories LimitedANDACurrent
55111-340Amlodipine Besylate and Benazepril HydrochlorideAmlodipine Besylate and Benazepril HydrochlorideDr.Reddy's Laboratories LimitedANDACurrent
55111-340Amlodipine Besylate and Benazepril HydrochlorideAmlodipine Besylate and Benazepril HydrochlorideDr.Reddy's Laboratories LimitedANDACurrent
55111-340Amlodipine Besylate and Benazepril HydrochlorideAmlodipine Besylate and Benazepril HydrochlorideDr.Reddy's Laboratories LimitedANDACurrent
55111-341Amlodipine Besylate and Benazepril HydrochlorideAmlodipine Besylate and Benazepril HydrochlorideDr.Reddy's Laboratories LimitedANDACurrent
55111-341Amlodipine Besylate and Benazepril HydrochlorideAmlodipine Besylate and Benazepril HydrochlorideDr.Reddy's Laboratories LimitedANDACurrent
55111-341Amlodipine Besylate and Benazepril HydrochlorideAmlodipine Besylate and Benazepril HydrochlorideDr.Reddy's Laboratories LimitedANDACurrent
55111-341Amlodipine Besylate and Benazepril HydrochlorideAmlodipine Besylate and Benazepril HydrochlorideDr.Reddy's Laboratories LimitedANDACurrent
63629-1454Amlodipine Besylate and Benazepril HydrochlorideAmlodipine Besylate and Benazepril HydrochlorideBryant Ranch PrepackANDACurrent
63629-1454Amlodipine Besylate and Benazepril HydrochlorideAmlodipine Besylate and Benazepril HydrochlorideBryant Ranch PrepackANDACurrent
63629-1454Amlodipine Besylate and Benazepril HydrochlorideAmlodipine Besylate and Benazepril HydrochlorideBryant Ranch PrepackANDACurrent
63629-1454Amlodipine Besylate and Benazepril HydrochlorideAmlodipine Besylate and Benazepril HydrochlorideBryant Ranch PrepackANDACurrent
63629-7643Amlodipine Besylate and Benazepril HydrochlorideAmlodipine Besylate and Benazepril HydrochlorideBryant Ranch PrepackANDACurrent
63629-7643Amlodipine Besylate and Benazepril HydrochlorideAmlodipine Besylate and Benazepril HydrochlorideBryant Ranch PrepackANDACurrent
63629-7733Amlodipine Besylate and Benazepril HydrochlorideAmlodipine Besylate and Benazepril HydrochlorideBryant Ranch PrepackANDACurrent
63629-7733Amlodipine Besylate and Benazepril HydrochlorideAmlodipine Besylate and Benazepril HydrochlorideBryant Ranch PrepackANDACurrent
63629-7733Amlodipine Besylate and Benazepril HydrochlorideAmlodipine Besylate and Benazepril HydrochlorideBryant Ranch PrepackANDACurrent
68071-1905Amlodipine Besylate and Benazepril HydrochlorideAmlodipine Besylate and Benazepril HydrochlorideNuCare Pharmaceuticals, Inc.ANDACurrent
68071-1956Amlodipine Besylate and Benazepril HydrochlorideAmlodipine Besylate and Benazepril HydrochlorideNuCare Pharmaceuticals, Inc.ANDACurrent
68071-4065Amlodipine Besylate and Benazepril HydrochlorideAmlodipine Besylate and Benazepril HydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68788-8168Amlodipine Besylate and Benazepril HydrochlorideAmlodipine Besylate and Benazepril HydrochloridePreferred Pharmaceuticals Inc.ANDACurrent
70934-696Amlodipine Besylate and Benazepril HydrochlorideAmlodipine Besylate and Benazepril HydrochlorideDenton Pharma, Inc. dba Northwind PharmaceuticalsANDACurrent
70934-944Amlodipine Besylate and Benazepril HydrochlorideAmlodipine Besylate and Benazepril HydrochlorideDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-944Amlodipine Besylate and Benazepril HydrochlorideAmlodipine Besylate and Benazepril HydrochlorideDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent