FDA.reportPublic FDA data

Application 200268

Type
ANDA
Sponsor
AUROBINDO PHARMA LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PIOGLITAZONE HYDROCHLORIDEPIOGLITAZONE HYDROCHLORIDETABLET;ORALEQ 15MG BASENoNo
002PIOGLITAZONE HYDROCHLORIDEPIOGLITAZONE HYDROCHLORIDETABLET;ORALEQ 30MG BASENoNo
003PIOGLITAZONE HYDROCHLORIDEPIOGLITAZONE HYDROCHLORIDETABLET;ORALEQ 45MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0904-7090PioglitazonePioglitazoneMajor PharmaceuticalsANDACurrent
0904-7090PioglitazonePioglitazoneMajor PharmaceuticalsANDACurrent
0904-7096PioglitazonePioglitazoneMajor PharmaceuticalsANDACurrent
0904-7096PioglitazonePioglitazoneMajor PharmaceuticalsANDACurrent
43353-326Pioglitazone HydrochloridePioglitazone HydrochlorideAphena Pharma Solutions - Tennessee, LLCANDACurrent
50090-4556PioglitazonePioglitazoneA-S Medication SolutionsANDACurrent
50090-4556PioglitazonePioglitazoneA-S Medication SolutionsANDACurrent
50090-4556PioglitazonePioglitazoneA-S Medication SolutionsANDACurrent
50090-4586PioglitazonePioglitazoneA-S Medication SolutionsANDACurrent
50090-4586PioglitazonePioglitazoneA-S Medication SolutionsANDACurrent
50090-4586PioglitazonePioglitazoneA-S Medication SolutionsANDACurrent
50090-4605PioglitazonePioglitazoneA-S Medication SolutionsANDACurrent
50090-4605PioglitazonePioglitazoneA-S Medication SolutionsANDACurrent
52343-053Pioglitazone HydrochloridePioglitazone HydrochlorideACETRIS HEALTH, LLCANDACurrent
52343-054Pioglitazone HydrochloridePioglitazone HydrochlorideACETRIS HEALTH, LLCANDACurrent
52343-055Pioglitazone HydrochloridePioglitazone HydrochlorideACETRIS HEALTH, LLCANDACurrent
57237-219PioglitazonePioglitazoneRising Health, LLCANDACurrent
57237-219PioglitazonePioglitazoneRising Health, LLCANDACurrent
57237-219PioglitazonePioglitazoneRising Health, LLCANDACurrent
57237-219PioglitazonePioglitazoneRising Health, LLCANDACurrent
57237-220PioglitazonePioglitazoneRising Health, LLCANDACurrent
57237-220PioglitazonePioglitazoneRising Health, LLCANDACurrent
57237-220PioglitazonePioglitazoneRising Health, LLCANDACurrent
57237-220PioglitazonePioglitazoneRising Health, LLCANDACurrent
57237-221PioglitazonePioglitazoneRising Health, LLCANDACurrent
57237-221PioglitazonePioglitazoneRising Health, LLCANDACurrent
57237-221PioglitazonePioglitazoneRising Health, LLCANDACurrent
57237-221PioglitazonePioglitazoneRising Health, LLCANDACurrent
65862-512PIOGLITAZONE HYDROCHLORIDEpioglitazone hydrochlorideAurobindo Pharma LimitedANDACurrent
65862-512PIOGLITAZONE HYDROCHLORIDEpioglitazone hydrochlorideAurobindo Pharma LimitedANDACurrent
65862-512PIOGLITAZONE HYDROCHLORIDEpioglitazone hydrochlorideAurobindo Pharma LimitedANDACurrent
65862-512PIOGLITAZONE HYDROCHLORIDEpioglitazone hydrochlorideAurobindo Pharma LimitedANDACurrent
65862-513PIOGLITAZONE HYDROCHLORIDEpioglitazone hydrochlorideAurobindo Pharma LimitedANDACurrent
65862-513PIOGLITAZONE HYDROCHLORIDEpioglitazone hydrochlorideAurobindo Pharma LimitedANDACurrent
65862-513PIOGLITAZONE HYDROCHLORIDEpioglitazone hydrochlorideAurobindo Pharma LimitedANDACurrent
65862-513PIOGLITAZONE HYDROCHLORIDEpioglitazone hydrochlorideAurobindo Pharma LimitedANDACurrent
65862-514PIOGLITAZONE HYDROCHLORIDEpioglitazone hydrochlorideAurobindo Pharma LimitedANDACurrent
65862-514PIOGLITAZONE HYDROCHLORIDEpioglitazone hydrochlorideAurobindo Pharma LimitedANDACurrent
65862-514PIOGLITAZONE HYDROCHLORIDEpioglitazone hydrochlorideAurobindo Pharma LimitedANDACurrent
65862-514PIOGLITAZONE HYDROCHLORIDEpioglitazone hydrochlorideAurobindo Pharma LimitedANDACurrent
68071-2882PIOGLITAZONE HYDROCHLORIDEpioglitazone hydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2886PioglitazonePioglitazoneNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4964PioglitazonePioglitazoneNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4964PioglitazonePioglitazoneNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5199PioglitazonePioglitazoneNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5210PioglitazonePioglitazoneNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5210PioglitazonePioglitazoneNuCare Pharmaceuticals,Inc.ANDACurrent
68788-7511PioglitazonePioglitazonePreferred Pharmaceuticals, Inc.ANDACurrent
68788-7511PioglitazonePioglitazonePreferred Pharmaceuticals, Inc.ANDACurrent
68788-7511PioglitazonePioglitazonePreferred Pharmaceuticals, Inc.ANDACurrent
68788-7511PioglitazonePioglitazonePreferred Pharmaceuticals, Inc.ANDACurrent
68788-7514PioglitazonePioglitazonePreferred Pharmaceuticals, Inc.ANDACurrent
68788-7514PioglitazonePioglitazonePreferred Pharmaceuticals, Inc.ANDACurrent
68788-7514PioglitazonePioglitazonePreferred Pharmaceuticals, Inc.ANDACurrent
70518-2129PioglitazonePioglitazoneREMEDYREPACK INC.ANDACurrent
70518-2129PioglitazonePioglitazoneREMEDYREPACK INC.ANDACurrent
70518-2129PioglitazonePioglitazoneREMEDYREPACK INC.ANDACurrent
70518-2129PioglitazonePioglitazoneREMEDYREPACK INC.ANDACurrent
70518-2129PioglitazonePioglitazoneREMEDYREPACK INC.ANDACurrent
70518-2431PioglitazonePioglitazoneREMEDYREPACK INC.ANDACurrent
70518-2431PioglitazonePioglitazoneREMEDYREPACK INC.ANDACurrent
70518-2431PioglitazonePioglitazoneREMEDYREPACK INC.ANDACurrent
70518-2431PioglitazonePioglitazoneREMEDYREPACK INC.ANDACurrent
70518-2431PioglitazonePioglitazoneREMEDYREPACK INC.ANDACurrent
70518-2609PioglitazonePioglitazoneREMEDYREPACK INC.ANDACurrent
70518-2609PioglitazonePioglitazoneREMEDYREPACK INC.ANDACurrent
70518-2609PioglitazonePioglitazoneREMEDYREPACK INC.ANDACurrent
71335-1298PioglitazonePioglitazoneBryant Ranch PrepackANDACurrent
71335-1298PioglitazonePioglitazoneBryant Ranch PrepackANDACurrent
71335-1298PioglitazonePioglitazoneBryant Ranch PrepackANDACurrent
71335-1343PioglitazonePioglitazoneBryant Ranch PrepackANDACurrent
71335-1343PioglitazonePioglitazoneBryant Ranch PrepackANDACurrent
71335-1759PioglitazonePioglitazoneBryant Ranch PrepackANDACurrent
71335-1759PioglitazonePioglitazoneBryant Ranch PrepackANDACurrent
71610-495PioglitazonePioglitazoneAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-497PIOGLITAZONE HYDROCHLORIDEpioglitazone hydrochlorideAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-497PIOGLITAZONE HYDROCHLORIDEpioglitazone hydrochlorideAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-522Pioglitazone HydrochloridePioglitazone HydrochlorideAphena Pharma Solutions - Tennessee, LLCANDACurrent
72189-105PIOGLITAZONEPIOGLITAZONEDIRECT RXANDACurrent