FDA.reportPublic FDA data

Application 090149

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 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
42254-073Amlodipine Besylate and Benazepril HydrochlorideAmlodipine Besylate and Benazepril HydrochlorideRebel Distributors CorpANDACurrent
42254-074Amlodipine Besylate and Benazepril HydrochlorideAmlodipine Besylate and Benazepril HydrochlorideRebel Distributors CorpANDACurrent
50090-1463Amlodipine Besylate and Benazepril HydrochlorideAmlodipine Besylate and Benazepril HydrochlorideA-S Medication SolutionsANDACurrent
55111-586Amlodipine Besylate and Benazepril HydrochlorideAmlodipine Besylate and Benazepril HydrochlorideDr.Reddy's Laboratories LimitedANDACurrent
55111-586Amlodipine Besylate and Benazepril HydrochlorideAmlodipine Besylate and Benazepril HydrochlorideDr.Reddy's Laboratories LimitedANDACurrent
55111-586Amlodipine Besylate and Benazepril HydrochlorideAmlodipine Besylate and Benazepril HydrochlorideDr.Reddy's Laboratories LimitedANDACurrent
55111-587Amlodipine Besylate and Benazepril HydrochlorideAmlodipine Besylate and Benazepril HydrochlorideDr.Reddy's Laboratories LimitedANDACurrent
55111-587Amlodipine Besylate and Benazepril HydrochlorideAmlodipine Besylate and Benazepril HydrochlorideDr.Reddy's Laboratories LimitedANDACurrent
55111-587Amlodipine Besylate and Benazepril HydrochlorideAmlodipine Besylate and Benazepril HydrochlorideDr.Reddy's Laboratories LimitedANDACurrent