Application 209042

Type
ANDA
Sponsor
ALKEM LABS 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
67877-499Amlodipine and olmesartan MedoxomilAmlodipine and olmesartan MedoxomilAscend Laboratories, LLCANDACurrent
67877-499Amlodipine and olmesartan MedoxomilAmlodipine and olmesartan MedoxomilAscend Laboratories, LLCANDACurrent
67877-499Amlodipine and olmesartan MedoxomilAmlodipine and olmesartan MedoxomilAscend Laboratories, LLCANDACurrent
67877-500Amlodipine and olmesartan MedoxomilAmlodipine and olmesartan MedoxomilAscend Laboratories, LLCANDACurrent
67877-500Amlodipine and olmesartan MedoxomilAmlodipine and olmesartan MedoxomilAscend Laboratories, LLCANDACurrent
67877-500Amlodipine and olmesartan MedoxomilAmlodipine and olmesartan MedoxomilAscend Laboratories, LLCANDACurrent
67877-501Amlodipine and olmesartan MedoxomilAmlodipine and olmesartan MedoxomilAscend Laboratories, LLCANDACurrent
67877-501Amlodipine and olmesartan MedoxomilAmlodipine and olmesartan MedoxomilAscend Laboratories, LLCANDACurrent
67877-501Amlodipine and olmesartan MedoxomilAmlodipine and olmesartan MedoxomilAscend Laboratories, LLCANDACurrent
67877-502Amlodipine and olmesartan MedoxomilAmlodipine and olmesartan MedoxomilAscend Laboratories, LLCANDACurrent
67877-502Amlodipine and olmesartan MedoxomilAmlodipine and olmesartan MedoxomilAscend Laboratories, LLCANDACurrent
67877-502Amlodipine and olmesartan MedoxomilAmlodipine and olmesartan MedoxomilAscend Laboratories, LLCANDACurrent