FDA.reportPublic FDA data

Application 200823

Type
ANDA
Sponsor
AUROBINDO PHARMA LTD

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
57237-217Pioglitazone Hydrochloride and Metformin HydrochloridePioglitazone Hydrochloride and Metformin HydrochlorideRising Health, LLCANDACurrent
57237-217Pioglitazone Hydrochloride and Metformin HydrochloridePioglitazone Hydrochloride and Metformin HydrochlorideRising Health, LLCANDACurrent
57237-217Pioglitazone Hydrochloride and Metformin HydrochloridePioglitazone Hydrochloride and Metformin HydrochlorideRising Health, LLCANDACurrent
57237-217Pioglitazone Hydrochloride and Metformin HydrochloridePioglitazone Hydrochloride and Metformin HydrochlorideRising Health, LLCANDACurrent
57237-218Pioglitazone Hydrochloride and Metformin HydrochloridePioglitazone Hydrochloride and Metformin HydrochlorideRising Health, LLCANDACurrent
57237-218Pioglitazone Hydrochloride and Metformin HydrochloridePioglitazone Hydrochloride and Metformin HydrochlorideRising Health, LLCANDACurrent
57237-218Pioglitazone Hydrochloride and Metformin HydrochloridePioglitazone Hydrochloride and Metformin HydrochlorideRising Health, LLCANDACurrent
57237-218Pioglitazone Hydrochloride and Metformin HydrochloridePioglitazone Hydrochloride and Metformin HydrochlorideRising Health, LLCANDACurrent
65862-525Pioglitazone Hydrochloride and Metformin HydrochloridePioglitazone Hydrochloride and Metformin HydrochlorideAurobindo Pharma LimitedANDACurrent
65862-525Pioglitazone Hydrochloride and Metformin HydrochloridePioglitazone Hydrochloride and Metformin HydrochlorideAurobindo Pharma LimitedANDACurrent
65862-525Pioglitazone Hydrochloride and Metformin HydrochloridePioglitazone Hydrochloride and Metformin HydrochlorideAurobindo Pharma LimitedANDACurrent
65862-525Pioglitazone Hydrochloride and Metformin HydrochloridePioglitazone Hydrochloride and Metformin HydrochlorideAurobindo Pharma LimitedANDACurrent
65862-526Pioglitazone Hydrochloride and Metformin HydrochloridePioglitazone Hydrochloride and Metformin HydrochlorideAurobindo Pharma LimitedANDACurrent
65862-526Pioglitazone Hydrochloride and Metformin HydrochloridePioglitazone Hydrochloride and Metformin HydrochlorideAurobindo Pharma LimitedANDACurrent
65862-526Pioglitazone Hydrochloride and Metformin HydrochloridePioglitazone Hydrochloride and Metformin HydrochlorideAurobindo Pharma LimitedANDACurrent
65862-526Pioglitazone Hydrochloride and Metformin HydrochloridePioglitazone Hydrochloride and Metformin HydrochlorideAurobindo Pharma LimitedANDACurrent