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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A200268-001PIOGLITAZONE HYDROCHLORIDEPIOGLITAZONE HYDROCHLORIDEEQ 15MG BASETABLET / ORALAB2013-02-13
A200268-002PIOGLITAZONE HYDROCHLORIDEPIOGLITAZONE HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2013-02-13
A200268-003PIOGLITAZONE HYDROCHLORIDEPIOGLITAZONE HYDROCHLORIDEEQ 45MG BASETABLET / ORALAB2013-02-13

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A200268-001AB
A200268-002AB
A200268-003AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A200268-001PIOGLITAZONE HYDROCHLORIDEEQ 15MG BASETABLET / ORALAB2013-02-1384e616aacf4f…
2026-09-14 22:38:342026-08A200268-002PIOGLITAZONE HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2013-02-1384e616aacf4f…
2026-09-14 22:38:342026-08A200268-003PIOGLITAZONE HYDROCHLORIDEEQ 45MG BASETABLET / ORALAB2013-02-1384e616aacf4f…
2026-08-18 06:07:402026-07A200268-001PIOGLITAZONE HYDROCHLORIDEEQ 15MG BASETABLET / ORALAB2013-02-13caaa826d4ba7…
2026-08-18 06:07:402026-07A200268-002PIOGLITAZONE HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2013-02-13caaa826d4ba7…
2026-08-18 06:07:402026-07A200268-003PIOGLITAZONE HYDROCHLORIDEEQ 45MG BASETABLET / ORALAB2013-02-13caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A200268-001PIOGLITAZONE HYDROCHLORIDEEQ 15MG BASETABLET / ORALAB2013-02-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02A200268-002PIOGLITAZONE HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2013-02-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02A200268-003PIOGLITAZONE HYDROCHLORIDEEQ 45MG BASETABLET / ORALAB2013-02-13011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200268-001PIOGLITAZONE HYDROCHLORIDEEQ 15MG BASETABLET / ORALAB2013-02-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200268-002PIOGLITAZONE HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2013-02-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200268-003PIOGLITAZONE HYDROCHLORIDEEQ 45MG BASETABLET / ORALAB2013-02-1331067a03dcf5…
2025-08-23 18:47 UTC2025-08A200268-001PIOGLITAZONE HYDROCHLORIDEEQ 15MG BASETABLET / ORALAB2013-02-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08A200268-002PIOGLITAZONE HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2013-02-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08A200268-003PIOGLITAZONE HYDROCHLORIDEEQ 45MG BASETABLET / ORALAB2013-02-136a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200268-001PIOGLITAZONE HYDROCHLORIDEEQ 15MG BASETABLET / ORALAB2013-02-13fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200268-002PIOGLITAZONE HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2013-02-13fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200268-003PIOGLITAZONE HYDROCHLORIDEEQ 45MG BASETABLET / ORALAB2013-02-13fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200268-001PIOGLITAZONE HYDROCHLORIDEEQ 15MG BASETABLET / ORALAB2013-02-13b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200268-002PIOGLITAZONE HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2013-02-13b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200268-003PIOGLITAZONE HYDROCHLORIDEEQ 45MG BASETABLET / ORALAB2013-02-13b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200268-001PIOGLITAZONE HYDROCHLORIDEEQ 15MG BASETABLET / ORALAB2013-02-1303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200268-002PIOGLITAZONE HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2013-02-1303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200268-003PIOGLITAZONE HYDROCHLORIDEEQ 45MG BASETABLET / ORALAB2013-02-1303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200268-001PIOGLITAZONE HYDROCHLORIDEEQ 15MG BASETABLET / ORALAB2013-02-132680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200268-002PIOGLITAZONE HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2013-02-132680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200268-003PIOGLITAZONE HYDROCHLORIDEEQ 45MG BASETABLET / ORALAB2013-02-132680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200268-001PIOGLITAZONE HYDROCHLORIDEEQ 15MG BASETABLET / ORALAB2013-02-135bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200268-002PIOGLITAZONE HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2013-02-135bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200268-003PIOGLITAZONE HYDROCHLORIDEEQ 45MG BASETABLET / ORALAB2013-02-135bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200268-001PIOGLITAZONE HYDROCHLORIDEEQ 15MG BASETABLET / ORALAB2013-02-13d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200268-002PIOGLITAZONE HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2013-02-13d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200268-003PIOGLITAZONE HYDROCHLORIDEEQ 45MG BASETABLET / ORALAB2013-02-13d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A200268-001PIOGLITAZONE HYDROCHLORIDEEQ 15MG BASETABLET / ORALAB2013-02-13d06236e962d9…
2024-10-29 15:01 UTC2024-10A200268-002PIOGLITAZONE HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2013-02-13d06236e962d9…
2024-10-29 15:01 UTC2024-10A200268-003PIOGLITAZONE HYDROCHLORIDEEQ 45MG BASETABLET / ORALAB2013-02-13d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A200268-001PIOGLITAZONE HYDROCHLORIDEEQ 15MG BASETABLET / ORALAB2013-02-1379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A200268-002PIOGLITAZONE HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2013-02-1379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A200268-003PIOGLITAZONE HYDROCHLORIDEEQ 45MG BASETABLET / ORALAB2013-02-1379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A200268-001PIOGLITAZONE HYDROCHLORIDEEQ 15MG BASETABLET / ORALAB2013-02-13301d65b070ca…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A200268-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A200268-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A200268-003AB184e616aacf4f…
2026-08-18 06:07:402026-07A200268-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A200268-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A200268-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A200268-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A200268-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A200268-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200268-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200268-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200268-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A200268-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A200268-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A200268-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200268-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200268-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200268-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200268-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200268-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200268-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200268-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200268-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200268-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200268-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200268-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200268-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200268-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200268-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200268-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200268-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200268-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200268-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A200268-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A200268-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A200268-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A200268-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A200268-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A200268-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A200268-001AB1301d65b070ca…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 2 of 2 · 23 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PioglitazonePIOGLITAZONEProficient Rx LPf725cdaf-fc7a-40d6-ba64-1dccd1b25d7a2024-06-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200268
application number: ANDA200268
PioglitazonePIOGLITAZONEA-S Medication Solutions5f844e44-0f0d-4b28-9d34-b97780e1c6ec2023-02-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200268
application number: ANDA200268
ndc (product): 50090-4605
PioglitazonePIOGLITAZONEAphena Pharma Solutions - Tennessee, LLCf434ba0d-13f3-42ae-a2d5-cddb93fde1e82020-12-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200268
application number: ANDA200268
ndc (product): 71610-495

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 79 matching rows.

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