Application 021925

Type
NDA
Sponsor
TAKEDA PHARMS USA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DUETACTGLIMEPIRIDE; PIOGLITAZONE HYDROCHLORIDETABLET;ORAL2MG;30MGYesYes
002DUETACTGLIMEPIRIDE; PIOGLITAZONE HYDROCHLORIDETABLET;ORAL4MG;30MGYesNo

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021925-001DUETACTGLIMEPIRIDE; PIOGLITAZONE HYDROCHLORIDE2MG;30MGTABLET / ORALABRLD, RS2006-07-28
N021925-002DUETACTGLIMEPIRIDE; PIOGLITAZONE HYDROCHLORIDE4MG;30MGTABLET / ORALABRLD2006-07-28

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
N021925-001AB
N021925-002AB

Orange Book patents#

Current patent rows page 1 of 1 · 4 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N021925-00177001282027-01-30Drug product
N021925-00180711302028-06-08Drug product2011-12-15
N021925-00277001282027-01-30Drug product
N021925-00280711302028-06-08Drug product

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 3 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N021925-001DUETACT2MG;30MGTABLET / ORALABRLD, RS2006-07-2884e616aacf4f…
2026-09-14 22:38:342026-08N021925-002DUETACT4MG;30MGTABLET / ORALABRLD2006-07-2884e616aacf4f…
2026-08-18 06:07:402026-07N021925-001DUETACT2MG;30MGTABLET / ORALABRLD, RS2006-07-28caaa826d4ba7…
2026-08-18 06:07:402026-07N021925-002DUETACT4MG;30MGTABLET / ORALABRLD2006-07-28caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N021925-001DUETACT2MG;30MGTABLET / ORALABRLD, RS2006-07-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021925-002DUETACT4MG;30MGTABLET / ORALABRLD2006-07-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021925-001DUETACT2MG;30MGTABLET / ORALABRLD, RS2006-07-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021925-002DUETACT4MG;30MGTABLET / ORALABRLD2006-07-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08N021925-001DUETACT2MG;30MGTABLET / ORALABRLD, RS2006-07-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021925-002DUETACT4MG;30MGTABLET / ORALABRLD2006-07-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021925-001DUETACT2MG;30MGTABLET / ORALABRLD, RS2006-07-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021925-002DUETACT4MG;30MGTABLET / ORALABRLD2006-07-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021925-001DUETACT2MG;30MGTABLET / ORALABRLD, RS2006-07-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021925-002DUETACT4MG;30MGTABLET / ORALABRLD2006-07-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021925-001DUETACT2MG;30MGTABLET / ORALABRLD, RS2006-07-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021925-002DUETACT4MG;30MGTABLET / ORALABRLD2006-07-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021925-001DUETACT2MG;30MGTABLET / ORALABRLD, RS2006-07-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021925-002DUETACT4MG;30MGTABLET / ORALABRLD2006-07-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021925-001DUETACT2MG;30MGTABLET / ORALABRLD, RS2006-07-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021925-002DUETACT4MG;30MGTABLET / ORALABRLD2006-07-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021925-001DUETACT2MG;30MGTABLET / ORALABRLD, RS2006-07-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021925-002DUETACT4MG;30MGTABLET / ORALABRLD2006-07-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021925-001DUETACT2MG;30MGTABLET / ORALABRLD, RS2006-07-28d06236e962d9…
2024-10-29 15:01 UTC2024-10N021925-002DUETACT4MG;30MGTABLET / ORALABRLD2006-07-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021925-001DUETACT2MG;30MGTABLET / ORALABRLD, RS2006-07-2879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021925-002DUETACT4MG;30MGTABLET / ORALABRLD2006-07-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021925-001DUETACT2MG;30MGTABLET / ORALABRLD, RS2006-07-28301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021925-002DUETACT4MG;30MGTABLET / ORALABRLD2006-07-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021925-001DUETACT2MG;30MGTABLET / ORALABRLD, RS2006-07-281e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021925-002DUETACT4MG;30MGTABLET / ORALABRLD2006-07-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021925-001DUETACT2MG;30MGTABLET / ORALABRLD, RS2006-07-288072bd15b7f6…
2024-05-31 18:47 UTC2024-05N021925-002DUETACT4MG;30MGTABLET / ORALABRLD2006-07-288072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021925-001DUETACT2MG;30MGTABLET / ORALABRLD, RS2006-07-285c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021925-002DUETACT4MG;30MGTABLET / ORALABRLD2006-07-285c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021925-001DUETACT2MG;30MGTABLET / ORALABRLD, RS2006-07-285d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021925-002DUETACT4MG;30MGTABLET / ORALABRLD2006-07-285d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021925-001DUETACT2MG;30MGTABLET / ORALABRLD, RS2006-07-284b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021925-002DUETACT4MG;30MGTABLET / ORALABRLD2006-07-284b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021925-001DUETACT2MG;30MGTABLET / ORALABRLD, RS2006-07-2874a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021925-002DUETACT4MG;30MGTABLET / ORALABRLD2006-07-2874a2ff9319b5…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08N021925-001AB184e616aacf4f…
2026-09-14 22:38:342026-08N021925-002AB184e616aacf4f…
2026-08-18 06:07:402026-07N021925-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07N021925-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N021925-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021925-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021925-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021925-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N021925-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021925-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021925-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021925-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021925-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021925-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021925-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021925-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021925-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021925-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021925-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021925-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021925-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021925-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021925-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N021925-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021925-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021925-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021925-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021925-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021925-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021925-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021925-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05N021925-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021925-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021925-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021925-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021925-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021925-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021925-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021925-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021925-002AB174a2ff9319b5…

Observed Orange Book patent history#

Patent history page 3 of 5 · 172 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2022-03-09 01:35 UTC2022-03N021925-00177001282027-01-30Drug productbb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N021925-00180711302028-06-08Drug product2011-12-15bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N021925-00277001282027-01-30Drug productbb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N021925-00280711302028-06-08Drug productbb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021925-00177001282027-01-30Drug product782e0a99824c…
2021-12-28 21:50 UTC2021-12N021925-00180711302028-06-08Drug product2011-12-15782e0a99824c…
2021-12-28 21:50 UTC2021-12N021925-00277001282027-01-30Drug product782e0a99824c…
2021-12-28 21:50 UTC2021-12N021925-00280711302028-06-08Drug product782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021925-00177001282027-01-30Drug product87673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021925-00180711302028-06-08Drug product2011-12-1587673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021925-00277001282027-01-30Drug product87673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021925-00280711302028-06-08Drug product87673890dc5c…
2021-03-12 10:30 UTC2021-03N021925-00177001282027-01-30Drug product5aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N021925-00180711302028-06-08Drug product2011-12-155aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N021925-00277001282027-01-30Drug product5aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N021925-00280711302028-06-08Drug product5aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N021925-00177001282027-01-30Drug product8869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021925-00180711302028-06-08Drug product2011-12-158869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021925-00277001282027-01-30Drug product8869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021925-00280711302028-06-08Drug product8869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021925-00177001282027-01-30Drug productc0c555d07b60…
2020-11-12 02:37 UTC2020-11N021925-00180711302028-06-08Drug product2011-12-15c0c555d07b60…
2020-11-12 02:37 UTC2020-11N021925-00277001282027-01-30Drug productc0c555d07b60…
2020-11-12 02:37 UTC2020-11N021925-00280711302028-06-08Drug productc0c555d07b60…
2019-12-14 00:12 UTC2019-12N021925-00177001282027-01-30Drug product3f01610625f2…
2019-12-14 00:12 UTC2019-12N021925-00180711302028-06-08Drug product2011-12-153f01610625f2…
2019-12-14 00:12 UTC2019-12N021925-00277001282027-01-30Drug product3f01610625f2…
2019-12-14 00:12 UTC2019-12N021925-00280711302028-06-08Drug product3f01610625f2…
2019-09-15 20:21 UTC2019-09N021925-00177001282027-01-30Drug productb00525d2431f…
2019-09-15 20:21 UTC2019-09N021925-00180711302028-06-08Drug product2011-12-15b00525d2431f…
2019-09-15 20:21 UTC2019-09N021925-00277001282027-01-30Drug productb00525d2431f…
2019-09-15 20:21 UTC2019-09N021925-00280711302028-06-08Drug productb00525d2431f…
2019-07-19 19:46 UTC2019-07N021925-00177001282027-01-30Drug productea99ee380514…
2019-07-19 19:46 UTC2019-07N021925-00180711302028-06-08Drug product2011-12-15ea99ee380514…
2019-07-19 19:46 UTC2019-07N021925-00277001282027-01-30Drug productea99ee380514…
2019-07-19 19:46 UTC2019-07N021925-00280711302028-06-08Drug productea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N021925-00177001282027-01-30Drug product6a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N021925-00180711302028-06-08Drug product2011-12-156a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N021925-00277001282027-01-30Drug product6a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N021925-00280711302028-06-08Drug product6a51e52b5d6a…

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
pioglitazone and glimepiridePIOGLITAZONE AND GLIMEPIRIDEPrasco Laboratoriesea385b3d-cb4c-4550-97b0-93a86533f6dc2025-12-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 021925
application number: NDA021925
ndc (product): 66993-821
ndc (product): 66993-822
DuetactPIOGLITAZONE AND GLIMEPIRIDETakeda Pharmaceuticals America, Inc.f8b0c917-3fdd-4a28-a47d-6225b81954582025-03-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 021925
application number: NDA021925
ndc (product): 64764-304
ndc (product): 64764-302

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 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
64764-302Duetactpioglitazone and glimepirideTakeda Pharmaceuticals America, Inc.NDACurrent
64764-302Duetactpioglitazone and glimepirideTakeda Pharmaceuticals America, Inc.NDACurrent
64764-302Duetactpioglitazone and glimepirideTakeda Pharmaceuticals America, Inc.NDACurrent
64764-302Duetactpioglitazone and glimepirideTakeda Pharmaceuticals America, Inc.NDACurrent
64764-304Duetactpioglitazone and glimepirideTakeda Pharmaceuticals America, Inc.NDACurrent
64764-304Duetactpioglitazone and glimepirideTakeda Pharmaceuticals America, Inc.NDACurrent
64764-304Duetactpioglitazone and glimepirideTakeda Pharmaceuticals America, Inc.NDACurrent
64764-304Duetactpioglitazone and glimepirideTakeda Pharmaceuticals America, Inc.NDACurrent
66993-821pioglitazone and glimepiridepioglitazone and glimepiridePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-821pioglitazone and glimepiridepioglitazone and glimepiridePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-822pioglitazone and glimepiridepioglitazone and glimepiridePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-822pioglitazone and glimepiridepioglitazone and glimepiridePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
50917SUPPL2017-12-27
50860SUPPL2017-12-26
50859SUPPL2017-12-26
46140SUPPL2016-12-13
37889SUPPL2015-03-19
28857SUPPL2015-03-17
28856SUPPL2013-11-14
28854SUPPL2013-11-14
16582SUPPL2013-11-14
16580SUPPL2013-11-14
6466SUPPL2012-05-22
37888SUPPL2011-08-04
28855SUPPL2011-08-04
16581SUPPL2011-08-04
6465SUPPL2011-08-04
37887SUPPL2010-09-29
6464SUPPL2010-09-28
6463SUPPL2009-10-26
28853SUPPL2009-01-06
16579SUPPL2009-01-06
21872ORIG2008-09-04
28852SUPPL2007-10-04
28851SUPPL2007-10-04
16578SUPPL2007-10-04
37886SUPPL2007-09-26
28850SUPPL2007-09-11
16577SUPPL2007-09-07
23684ORIG2007-08-15
37885SUPPL2007-02-23
6462SUPPL2007-02-12
37884ORIG2006-08-04
28849ORIG2006-08-04