FDA.reportPublic FDA data

Application 091273

Type
ANDA
Sponsor
SANDOZ

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDETABLET;ORAL500MG;EQ 15MG BASENoNo
002PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDETABLET;ORAL850MG;EQ 15MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0781-5626Pioglitazone and metforminPioglitazone and metforminSandoz IncANDACurrent
0781-5626Pioglitazone and metforminPioglitazone and metforminSandoz IncANDACurrent
0781-5627Pioglitazone and metforminPioglitazone and metforminSandoz IncANDACurrent
0781-5627Pioglitazone and metforminPioglitazone and metforminSandoz IncANDACurrent
70882-105Pioglitazone and metforminPioglitazone and metforminCambridge Therapeutics Technologies, LLCANDACurrent