FDA.reportPublic FDA data

Application 209028

Type
ANDA
Sponsor
PRINSTON INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TELMISARTAN AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; TELMISARTANTABLET;ORAL12.5MG;40MGNoNo
002TELMISARTAN AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; TELMISARTANTABLET;ORAL12.5MG;80MGNoNo
003TELMISARTAN AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; TELMISARTANTABLET;ORAL25MG;80MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
43547-441TELMISARTAN AND HYDROCHLOROTHIAZIDEtelmisartan and hydrochlorothiazideSolco Healthcare LLCANDACurrent
43547-441TELMISARTAN AND HYDROCHLOROTHIAZIDEtelmisartan and hydrochlorothiazideSolco Healthcare LLCANDACurrent
43547-441TELMISARTAN AND HYDROCHLOROTHIAZIDEtelmisartan and hydrochlorothiazideSolco Healthcare LLCANDACurrent
43547-442TELMISARTAN AND HYDROCHLOROTHIAZIDEtelmisartan and hydrochlorothiazideSolco Healthcare LLCANDACurrent
43547-442TELMISARTAN AND HYDROCHLOROTHIAZIDEtelmisartan and hydrochlorothiazideSolco Healthcare LLCANDACurrent
43547-442TELMISARTAN AND HYDROCHLOROTHIAZIDEtelmisartan and hydrochlorothiazideSolco Healthcare LLCANDACurrent
43547-443TELMISARTAN AND HYDROCHLOROTHIAZIDEtelmisartan and hydrochlorothiazideSolco Healthcare LLCANDACurrent
43547-443TELMISARTAN AND HYDROCHLOROTHIAZIDEtelmisartan and hydrochlorothiazideSolco Healthcare LLCANDACurrent
43547-443TELMISARTAN AND HYDROCHLOROTHIAZIDEtelmisartan and hydrochlorothiazideSolco Healthcare LLCANDACurrent