FDA.reportPublic FDA data

Application 201049

Type
ANDA
Sponsor
SANDOZ

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PIOGLITAZONE HYDROCHLORIDE AND GLIMEPIRIDEGLIMEPIRIDE; PIOGLITAZONE HYDROCHLORIDETABLET;ORAL2MG;30MGNoNo
002PIOGLITAZONE HYDROCHLORIDE AND GLIMEPIRIDEGLIMEPIRIDE; PIOGLITAZONE HYDROCHLORIDETABLET;ORAL4MG;30MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0781-5634Pioglitazone hydrochloride and glimepiridePioglitazone hydrochloride and glimepirideSandoz IncANDACurrent
0781-5634Pioglitazone hydrochloride and glimepiridePioglitazone hydrochloride and glimepirideSandoz IncANDACurrent
0781-5635Pioglitazone hydrochloride and glimepiridePioglitazone hydrochloride and glimepirideSandoz IncANDACurrent
0781-5635Pioglitazone hydrochloride and glimepiridePioglitazone hydrochloride and glimepirideSandoz IncANDACurrent