FDA.reportPublic FDA data

Application 207073

Type
ANDA
Sponsor
ALEMBIC PHARMS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AMLODIPINE AND OLMESARTAN MEDOXOMILAMLODIPINE BESYLATE; OLMESARTAN MEDOXOMILTABLET;ORALEQ 5MG BASE;20MGNoNo
002AMLODIPINE AND OLMESARTAN MEDOXOMILAMLODIPINE BESYLATE; OLMESARTAN MEDOXOMILTABLET;ORALEQ 5MG BASE;40MGNoNo
003AMLODIPINE AND OLMESARTAN MEDOXOMILAMLODIPINE BESYLATE; OLMESARTAN MEDOXOMILTABLET;ORALEQ 10MG BASE;20MGNoNo
004AMLODIPINE AND OLMESARTAN MEDOXOMILAMLODIPINE BESYLATE; OLMESARTAN MEDOXOMILTABLET;ORALEQ 10MG BASE;40MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
46708-212Amlodipine besylate and Olmesartran medoxomilAmlodipine besylate and Olmesartran medoxomilAlembic Pharmaceuticals LimitedANDACurrent
46708-212Amlodipine besylate and Olmesartran medoxomilAmlodipine besylate and Olmesartran medoxomilAlembic Pharmaceuticals LimitedANDACurrent
46708-213Amlodipine besylate and Olmesartran medoxomilAmlodipine besylate and Olmesartran medoxomilAlembic Pharmaceuticals LimitedANDACurrent
46708-213Amlodipine besylate and Olmesartran medoxomilAmlodipine besylate and Olmesartran medoxomilAlembic Pharmaceuticals LimitedANDACurrent
46708-214Amlodipine besylate and Olmesartran medoxomilAmlodipine besylate and Olmesartran medoxomilAlembic Pharmaceuticals LimitedANDACurrent
46708-214Amlodipine besylate and Olmesartran medoxomilAmlodipine besylate and Olmesartran medoxomilAlembic Pharmaceuticals LimitedANDACurrent
46708-215Amlodipine besylate and Olmesartran medoxomilAmlodipine besylate and Olmesartran medoxomilAlembic Pharmaceuticals LimitedANDACurrent
46708-215Amlodipine besylate and Olmesartran medoxomilAmlodipine besylate and Olmesartran medoxomilAlembic Pharmaceuticals LimitedANDACurrent
62332-212Amlodipine besylate and Olmesartran medoxomilAmlodipine besylate and Olmesartran medoxomilAlembic Pharmaceuticals Inc.ANDACurrent
62332-212Amlodipine besylate and Olmesartran medoxomilAmlodipine besylate and Olmesartran medoxomilAlembic Pharmaceuticals Inc.ANDACurrent
62332-212Amlodipine besylate and Olmesartran medoxomilAmlodipine besylate and Olmesartran medoxomilAlembic Pharmaceuticals Inc.ANDACurrent
62332-212Amlodipine besylate and Olmesartran medoxomilAmlodipine besylate and Olmesartran medoxomilAlembic Pharmaceuticals Inc.ANDACurrent
62332-213Amlodipine besylate and Olmesartran medoxomilAmlodipine besylate and Olmesartran medoxomilAlembic Pharmaceuticals Inc.ANDACurrent
62332-213Amlodipine besylate and Olmesartran medoxomilAmlodipine besylate and Olmesartran medoxomilAlembic Pharmaceuticals Inc.ANDACurrent
62332-213Amlodipine besylate and Olmesartran medoxomilAmlodipine besylate and Olmesartran medoxomilAlembic Pharmaceuticals Inc.ANDACurrent
62332-213Amlodipine besylate and Olmesartran medoxomilAmlodipine besylate and Olmesartran medoxomilAlembic Pharmaceuticals Inc.ANDACurrent
62332-214Amlodipine besylate and Olmesartran medoxomilAmlodipine besylate and Olmesartran medoxomilAlembic Pharmaceuticals Inc.ANDACurrent
62332-214Amlodipine besylate and Olmesartran medoxomilAmlodipine besylate and Olmesartran medoxomilAlembic Pharmaceuticals Inc.ANDACurrent
62332-214Amlodipine besylate and Olmesartran medoxomilAmlodipine besylate and Olmesartran medoxomilAlembic Pharmaceuticals Inc.ANDACurrent
62332-214Amlodipine besylate and Olmesartran medoxomilAmlodipine besylate and Olmesartran medoxomilAlembic Pharmaceuticals Inc.ANDACurrent
62332-215Amlodipine besylate and Olmesartran medoxomilAmlodipine besylate and Olmesartran medoxomilAlembic Pharmaceuticals Inc.ANDACurrent
62332-215Amlodipine besylate and Olmesartran medoxomilAmlodipine besylate and Olmesartran medoxomilAlembic Pharmaceuticals Inc.ANDACurrent
62332-215Amlodipine besylate and Olmesartran medoxomilAmlodipine besylate and Olmesartran medoxomilAlembic Pharmaceuticals Inc.ANDACurrent
62332-215Amlodipine besylate and Olmesartran medoxomilAmlodipine besylate and Olmesartran medoxomilAlembic Pharmaceuticals Inc.ANDACurrent