Application 077210

Type
ANDA
Sponsor
TEVA PHARMS USA

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 1.

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
A077210-001PIOGLITAZONE HYDROCHLORIDEPIOGLITAZONE HYDROCHLORIDEEQ 15MG BASETABLET / ORALAB2014-01-10
A077210-002PIOGLITAZONE HYDROCHLORIDEPIOGLITAZONE HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2014-01-10
A077210-003PIOGLITAZONE HYDROCHLORIDEPIOGLITAZONE HYDROCHLORIDEEQ 45MG BASETABLET / ORALAB2014-01-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A077210-001AB
A077210-002AB
A077210-003AB

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 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A077210-001PIOGLITAZONE HYDROCHLORIDEEQ 15MG BASETABLET / ORALAB2014-01-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077210-002PIOGLITAZONE HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2014-01-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077210-003PIOGLITAZONE HYDROCHLORIDEEQ 45MG BASETABLET / ORALAB2014-01-10011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077210-001PIOGLITAZONE HYDROCHLORIDEEQ 15MG BASETABLET / ORALAB2014-01-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077210-002PIOGLITAZONE HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2014-01-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077210-003PIOGLITAZONE HYDROCHLORIDEEQ 45MG BASETABLET / ORALAB2014-01-1031067a03dcf5…
2025-08-23 18:47 UTC2025-08A077210-001PIOGLITAZONE HYDROCHLORIDEEQ 15MG BASETABLET / ORALAB2014-01-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077210-002PIOGLITAZONE HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2014-01-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077210-003PIOGLITAZONE HYDROCHLORIDEEQ 45MG BASETABLET / ORALAB2014-01-106a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077210-001PIOGLITAZONE HYDROCHLORIDEEQ 15MG BASETABLET / ORALAB2014-01-10fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077210-002PIOGLITAZONE HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2014-01-10fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077210-003PIOGLITAZONE HYDROCHLORIDEEQ 45MG BASETABLET / ORALAB2014-01-10fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077210-001PIOGLITAZONE HYDROCHLORIDEEQ 15MG BASETABLET / ORALAB2014-01-10b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077210-002PIOGLITAZONE HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2014-01-10b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077210-003PIOGLITAZONE HYDROCHLORIDEEQ 45MG BASETABLET / ORALAB2014-01-10b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077210-001PIOGLITAZONE HYDROCHLORIDEEQ 15MG BASETABLET / ORALAB2014-01-1003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077210-002PIOGLITAZONE HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2014-01-1003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077210-003PIOGLITAZONE HYDROCHLORIDEEQ 45MG BASETABLET / ORALAB2014-01-1003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077210-001PIOGLITAZONE HYDROCHLORIDEEQ 15MG BASETABLET / ORALAB2014-01-102680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077210-002PIOGLITAZONE HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2014-01-102680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077210-003PIOGLITAZONE HYDROCHLORIDEEQ 45MG BASETABLET / ORALAB2014-01-102680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077210-001PIOGLITAZONE HYDROCHLORIDEEQ 15MG BASETABLET / ORALAB2014-01-105bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077210-002PIOGLITAZONE HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2014-01-105bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077210-003PIOGLITAZONE HYDROCHLORIDEEQ 45MG BASETABLET / ORALAB2014-01-105bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077210-001PIOGLITAZONE HYDROCHLORIDEEQ 15MG BASETABLET / ORALAB2014-01-10d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077210-002PIOGLITAZONE HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2014-01-10d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077210-003PIOGLITAZONE HYDROCHLORIDEEQ 45MG BASETABLET / ORALAB2014-01-10d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077210-001PIOGLITAZONE HYDROCHLORIDEEQ 15MG BASETABLET / ORALAB2014-01-10d06236e962d9…
2024-10-29 15:01 UTC2024-10A077210-002PIOGLITAZONE HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2014-01-10d06236e962d9…
2024-10-29 15:01 UTC2024-10A077210-003PIOGLITAZONE HYDROCHLORIDEEQ 45MG BASETABLET / ORALAB2014-01-10d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077210-001PIOGLITAZONE HYDROCHLORIDEEQ 15MG BASETABLET / ORALAB2014-01-1079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077210-002PIOGLITAZONE HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2014-01-1079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077210-003PIOGLITAZONE HYDROCHLORIDEEQ 45MG BASETABLET / ORALAB2014-01-1079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077210-001PIOGLITAZONE HYDROCHLORIDEEQ 15MG BASETABLET / ORALAB2014-01-10301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077210-002PIOGLITAZONE HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2014-01-10301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077210-003PIOGLITAZONE HYDROCHLORIDEEQ 45MG BASETABLET / ORALAB2014-01-10301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077210-001PIOGLITAZONE HYDROCHLORIDEEQ 15MG BASETABLET / ORALAB2014-01-101e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077210-002PIOGLITAZONE HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2014-01-101e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077210-003PIOGLITAZONE HYDROCHLORIDEEQ 45MG BASETABLET / ORALAB2014-01-101e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077210-001PIOGLITAZONE HYDROCHLORIDEEQ 15MG BASETABLET / ORALAB2014-01-108072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A077210-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077210-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077210-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077210-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077210-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077210-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077210-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077210-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077210-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077210-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077210-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077210-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077210-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077210-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077210-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077210-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077210-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077210-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077210-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077210-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077210-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077210-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077210-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077210-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077210-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077210-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077210-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077210-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077210-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077210-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077210-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077210-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077210-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077210-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077210-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077210-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077210-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077210-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077210-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077210-001AB18072bd15b7f6…

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 1 of 1 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PioglitazonePIOGLITAZONEBryant Ranch Prepackfbdaaa34-06c4-49af-85b4-91a85922b30b2026-02-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077210
application number: ANDA077210
ndc (product): 71335-1333
PioglitazonePIOGLITAZONEAvKARE22569835-bc9f-7787-e063-6394a90a62322026-01-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077210
application number: ANDA077210
PioglitazonePIOGLITAZONEAmerican Health Packagingf3a2222d-5156-4533-bb4b-74652c8eb9c72026-01-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077210
application number: ANDA077210
ndc (product): 60687-391
PioglitazonePIOGLITAZONENuCare Pharmaceuticals,Inc.bde7fa79-aafc-3ba0-e053-2a95a90aa4d22025-01-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077210
application number: ANDA077210
ndc (product): 68071-2373
PioglitazonePIOGLITAZONENuCare Pharmaceuticals,Inc.a4751cb4-0700-dd22-e053-2995a90adfdb2024-07-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077210
application number: ANDA077210
ndc (product): 68071-5245
PioglitazonePIOGLITAZONETeva Pharmaceuticals USA, Inc.c5c81c67-90cf-4e64-acb5-58b0358fa7422021-07-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077210
application number: ANDA077210
ndc (product): 0093-7273
ndc (product): 0093-7271
ndc (product): 0093-7272

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 69 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0093-7271PioglitazonePioglitazoneTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7271PioglitazonePioglitazoneTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7271PioglitazonePioglitazoneTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7271PioglitazonePioglitazoneTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7271PioglitazonePioglitazoneTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7271PioglitazonePioglitazoneTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7271PioglitazonePioglitazoneTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7271PioglitazonePioglitazoneTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7271PioglitazonePioglitazoneTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7272PioglitazonePioglitazoneTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7272PioglitazonePioglitazoneTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7272PioglitazonePioglitazoneTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7272PioglitazonePioglitazoneTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7272PioglitazonePioglitazoneTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7272PioglitazonePioglitazoneTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7272PioglitazonePioglitazoneTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7272PioglitazonePioglitazoneTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7272PioglitazonePioglitazoneTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7273PioglitazonePioglitazoneTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7273PioglitazonePioglitazoneTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7273PioglitazonePioglitazoneTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7273PioglitazonePioglitazoneTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7273PioglitazonePioglitazoneTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7273PioglitazonePioglitazoneTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7273PioglitazonePioglitazoneTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7273PioglitazonePioglitazoneTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7273PioglitazonePioglitazoneTeva Pharmaceuticals USA, Inc.ANDACurrent
50090-2390PioglitazonePioglitazoneA-S Medication SolutionsANDACurrent
50090-2390PioglitazonePioglitazoneA-S Medication SolutionsANDACurrent
50090-2401PioglitazonePioglitazoneA-S Medication SolutionsANDACurrent
50090-2401PioglitazonePioglitazoneA-S Medication SolutionsANDACurrent
50090-4780PioglitazonePioglitazoneA-S Medication SolutionsANDACurrent
50090-4780PioglitazonePioglitazoneA-S Medication SolutionsANDACurrent
53002-2755PioglitazonePioglitazoneRPK Pharmaceuticals, Inc.ANDACurrent
53002-2756PioglitazonePioglitazoneRPK Pharmaceuticals, Inc.ANDACurrent
53002-2757PioglitazonePioglitazoneRPK Pharmaceuticals, Inc.ANDACurrent
54458-864PioglitazonePioglitazoneInternational Laboratories, LLCANDACurrent
54458-865PioglitazonePioglitazoneInternational Laboratories, LLCANDACurrent
54458-866PioglitazonePioglitazoneInternational Laboratories, LLCANDACurrent
60687-391PioglitazonePioglitazoneAmerican Health PackagingANDACurrent
60687-391PioglitazonePioglitazoneAmerican Health PackagingANDACurrent
60687-391PioglitazonePioglitazoneAmerican Health PackagingANDACurrent
68071-2373PioglitazonePioglitazoneNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2437PioglitazonePioglitazoneNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4959PioglitazonePioglitazoneNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4959PioglitazonePioglitazoneNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5080PioglitazonePioglitazoneNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5080PioglitazonePioglitazoneNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5155PioglitazonePioglitazoneNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5155PioglitazonePioglitazoneNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5245PioglitazonePioglitazoneNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5245PioglitazonePioglitazoneNuCare Pharmaceuticals,Inc.ANDACurrent
68788-7989PioglitazonePioglitazonePreferred Pharmaceuticals, Inc.ANDACurrent
68788-7989PioglitazonePioglitazonePreferred Pharmaceuticals, Inc.ANDACurrent
70518-1815PioglitazonePioglitazoneREMEDYREPACK INC.ANDACurrent
70934-619PioglitazonePioglitazoneDenton Pharma, Inc. dba Northwind PharmaceuticalsANDACurrent
71335-1137PioglitazonePioglitazoneBryant Ranch PrepackANDACurrent
71335-1137PioglitazonePioglitazoneBryant Ranch PrepackANDACurrent
71335-1137PioglitazonePioglitazoneBryant Ranch PrepackANDACurrent
71335-1137PioglitazonePioglitazoneBryant Ranch PrepackANDACurrent
71335-1137PioglitazonePioglitazoneBryant Ranch PrepackANDACurrent
71335-1333PioglitazonePioglitazoneBryant Ranch PrepackANDACurrent
71335-1333PioglitazonePioglitazoneBryant Ranch PrepackANDACurrent
71335-1333PioglitazonePioglitazoneBryant Ranch PrepackANDACurrent
71335-1333PioglitazonePioglitazoneBryant Ranch PrepackANDACurrent
71335-1385PioglitazonePioglitazoneBryant Ranch PrepackANDACurrent
71335-1385PioglitazonePioglitazoneBryant Ranch PrepackANDACurrent
71335-1385PioglitazonePioglitazoneBryant Ranch PrepackANDACurrent
71335-1385PioglitazonePioglitazoneBryant Ranch PrepackANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
44344ORIG2009-11-12