FDA.reportPublic FDA data

Application 207216

Type
ANDA
Sponsor
AJANTA PHARMA 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
27241-083Amlodipine besylate and Olmesartan medoxomilAmlodipine besylate and Olmesartan medoxomilAjanta Pharma LimitedANDACurrent
27241-083Amlodipine besylate and Olmesartan medoxomilAmlodipine besylate and Olmesartan medoxomilAjanta Pharma USA Inc.ANDACurrent
27241-083Amlodipine besylate and Olmesartan medoxomilAmlodipine besylate and Olmesartan medoxomilAjanta Pharma LimitedANDACurrent
27241-083Amlodipine besylate and Olmesartan medoxomilAmlodipine besylate and Olmesartan medoxomilAjanta Pharma LimitedANDACurrent
27241-084Amlodipine besylate and Olmesartan medoxomilAmlodipine besylate and Olmesartan medoxomilAjanta Pharma LimitedANDACurrent
27241-084Amlodipine besylate and Olmesartan medoxomilAmlodipine besylate and Olmesartan medoxomilAjanta Pharma USA Inc.ANDACurrent
27241-084Amlodipine besylate and Olmesartan medoxomilAmlodipine besylate and Olmesartan medoxomilAjanta Pharma LimitedANDACurrent
27241-084Amlodipine besylate and Olmesartan medoxomilAmlodipine besylate and Olmesartan medoxomilAjanta Pharma LimitedANDACurrent
27241-085Amlodipine besylate and Olmesartan medoxomilAmlodipine besylate and Olmesartan medoxomilAjanta Pharma LimitedANDACurrent
27241-085Amlodipine besylate and Olmesartan medoxomilAmlodipine besylate and Olmesartan medoxomilAjanta Pharma USA Inc.ANDACurrent
27241-085Amlodipine besylate and Olmesartan medoxomilAmlodipine besylate and Olmesartan medoxomilAjanta Pharma LimitedANDACurrent
27241-085Amlodipine besylate and Olmesartan medoxomilAmlodipine besylate and Olmesartan medoxomilAjanta Pharma LimitedANDACurrent
27241-086Amlodipine besylate and Olmesartan medoxomilAmlodipine besylate and Olmesartan medoxomilAjanta Pharma LimitedANDACurrent
27241-086Amlodipine besylate and Olmesartan medoxomilAmlodipine besylate and Olmesartan medoxomilAjanta Pharma USA Inc.ANDACurrent
27241-086Amlodipine besylate and Olmesartan medoxomilAmlodipine besylate and Olmesartan medoxomilAjanta Pharma LimitedANDACurrent
27241-086Amlodipine besylate and Olmesartan medoxomilAmlodipine besylate and Olmesartan medoxomilAjanta Pharma LimitedANDACurrent