FDA.reportPublic FDA data

Application 207804

Type
ANDA
Sponsor
PRINSTON INC

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
43547-391OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDEolmesartan medoxomil and hydrochlorothiazideSolco Healthcare US, LLCANDACurrent
43547-391OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDEolmesartan medoxomil and hydrochlorothiazideSolco Healthcare US, LLCANDACurrent
43547-392OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDEolmesartan medoxomil and hydrochlorothiazideSolco Healthcare US, LLCANDACurrent
43547-392OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDEolmesartan medoxomil and hydrochlorothiazideSolco Healthcare US, LLCANDACurrent
43547-393OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDEolmesartan medoxomil and hydrochlorothiazideSolco Healthcare US, LLCANDACurrent
43547-393OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDEolmesartan medoxomil and hydrochlorothiazideSolco Healthcare US, LLCANDACurrent
70518-1347OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDEolmesartan medoxomil and hydrochlorothiazideREMEDYREPACK INC.ANDACurrent
70518-1347OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDEolmesartan medoxomil and hydrochlorothiazideREMEDYREPACK INC.ANDACurrent