FDA.reportPublic FDA data

Application 200532

Type
ANDA
Sponsor
TEVA PHARMS USA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMILTABLET;ORAL12.5MG;20MGNoNo
002OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMILTABLET;ORAL12.5MG;40MGNoNo
003OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMILTABLET;ORAL25MG;40MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0093-7615Olmesartan Medoxomil and HydrochlorothiazideOlmesartan Medoxomil and HydrochlorothiazideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7615Olmesartan Medoxomil and HydrochlorothiazideOlmesartan Medoxomil and HydrochlorothiazideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7616Olmesartan Medoxomil and HydrochlorothiazideOlmesartan Medoxomil and HydrochlorothiazideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7616Olmesartan Medoxomil and HydrochlorothiazideOlmesartan Medoxomil and HydrochlorothiazideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7617Olmesartan Medoxomil and HydrochlorothiazideOlmesartan Medoxomil and HydrochlorothiazideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7617Olmesartan Medoxomil and HydrochlorothiazideOlmesartan Medoxomil and HydrochlorothiazideTeva Pharmaceuticals USA, Inc.ANDACurrent
50090-3053Olmesartan Medoxomil and HydrochlorothiazideOlmesartan Medoxomil and HydrochlorothiazideA-S Medication SolutionsANDACurrent
50090-3348Olmesartan Medoxomil and HydrochlorothiazideOlmesartan Medoxomil and HydrochlorothiazideA-S Medication SolutionsANDACurrent
63629-7278Olmesartan Medoxomil and HydrochlorothiazideOlmesartan Medoxomil and HydrochlorothiazideBryant Ranch PrepackANDACurrent
63629-7278Olmesartan Medoxomil and HydrochlorothiazideOlmesartan Medoxomil and HydrochlorothiazideBryant Ranch PrepackANDACurrent