Application 209010

Type
ANDA
Sponsor
SCIEGEN PHARMS INC

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
50228-365Amlodipine and Olmesartan MedoxomilAmlodipine and Olmesartan MedoxomilScieGen Pharmaceuticals, IncANDACurrent
50228-366Amlodipine and Olmesartan MedoxomilAmlodipine and Olmesartan MedoxomilScieGen Pharmaceuticals, IncANDACurrent
50228-367Amlodipine and Olmesartan MedoxomilAmlodipine and Olmesartan MedoxomilScieGen Pharmaceuticals, IncANDACurrent
50228-368Amlodipine and Olmesartan MedoxomilAmlodipine and Olmesartan MedoxomilScieGen Pharmaceuticals, IncANDACurrent