Application 210656

Type
NDA
Sponsor
PFIZER INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DAURISMOGLASDEGIB MALEATETABLET;ORALEQ 25MG BASEYesNo
002DAURISMOGLASDEGIB MALEATETABLET;ORALEQ 100MG BASEYesYes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
N210656-001DAURISMOGLASDEGIB MALEATEEQ 25MG BASETABLET / ORALRLD2018-11-21
N210656-002DAURISMOGLASDEGIB MALEATEEQ 100MG BASETABLET / ORALRLD, RS2018-11-21

Orange Book patents#

Current patent rows page 1 of 1 · 10 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N210656-00184315972028-06-29Drug product2018-12-18
N210656-00181484012032-11-21Drug substance, Drug product2018-12-18
N210656-001104147482036-04-13Drug substance, Drug product2019-10-11
N210656-001111680662036-04-13U-32542021-12-08
N210656-001118913722036-04-13U-32542024-03-06
N210656-00284315972028-06-29Drug product2018-12-18
N210656-00281484012032-11-21Drug substance, Drug product2018-12-18
N210656-002104147482036-04-13Drug substance, Drug product2019-10-11
N210656-002111680662036-04-13U-32542021-12-08
N210656-002118913722036-04-13U-32542024-03-06

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 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N210656-001DAURISMOEQ 25MG BASETABLET / ORALRLD2018-11-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N210656-002DAURISMOEQ 100MG BASETABLET / ORALRLD, RS2018-11-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N210656-001DAURISMOEQ 25MG BASETABLET / ORALRLD2018-11-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N210656-002DAURISMOEQ 100MG BASETABLET / ORALRLD, RS2018-11-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08N210656-001DAURISMOEQ 25MG BASETABLET / ORALRLD2018-11-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08N210656-002DAURISMOEQ 100MG BASETABLET / ORALRLD, RS2018-11-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N210656-001DAURISMOEQ 25MG BASETABLET / ORALRLD2018-11-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N210656-002DAURISMOEQ 100MG BASETABLET / ORALRLD, RS2018-11-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N210656-001DAURISMOEQ 25MG BASETABLET / ORALRLD2018-11-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N210656-002DAURISMOEQ 100MG BASETABLET / ORALRLD, RS2018-11-21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N210656-001DAURISMOEQ 25MG BASETABLET / ORALRLD2018-11-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N210656-002DAURISMOEQ 100MG BASETABLET / ORALRLD, RS2018-11-2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N210656-001DAURISMOEQ 25MG BASETABLET / ORALRLD2018-11-212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N210656-002DAURISMOEQ 100MG BASETABLET / ORALRLD, RS2018-11-212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N210656-001DAURISMOEQ 25MG BASETABLET / ORALRLD2018-11-215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N210656-002DAURISMOEQ 100MG BASETABLET / ORALRLD, RS2018-11-215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N210656-001DAURISMOEQ 25MG BASETABLET / ORALRLD2018-11-21d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N210656-002DAURISMOEQ 100MG BASETABLET / ORALRLD, RS2018-11-21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N210656-001DAURISMOEQ 25MG BASETABLET / ORALRLD2018-11-21d06236e962d9…
2024-10-29 15:01 UTC2024-10N210656-002DAURISMOEQ 100MG BASETABLET / ORALRLD, RS2018-11-21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N210656-001DAURISMOEQ 25MG BASETABLET / ORALRLD2018-11-2179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N210656-002DAURISMOEQ 100MG BASETABLET / ORALRLD, RS2018-11-2179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N210656-001DAURISMOEQ 25MG BASETABLET / ORALRLD2018-11-21301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N210656-002DAURISMOEQ 100MG BASETABLET / ORALRLD, RS2018-11-21301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N210656-001DAURISMOEQ 25MG BASETABLET / ORALRLD2018-11-211e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N210656-002DAURISMOEQ 100MG BASETABLET / ORALRLD, RS2018-11-211e350fbaab3a…
2024-05-31 18:47 UTC2024-05N210656-001DAURISMOEQ 25MG BASETABLET / ORALRLD2018-11-218072bd15b7f6…
2024-05-31 18:47 UTC2024-05N210656-002DAURISMOEQ 100MG BASETABLET / ORALRLD, RS2018-11-218072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N210656-001DAURISMOEQ 25MG BASETABLET / ORALRLD2018-11-215c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N210656-002DAURISMOEQ 100MG BASETABLET / ORALRLD, RS2018-11-215c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N210656-001DAURISMOEQ 25MG BASETABLET / ORALRLD2018-11-215d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N210656-002DAURISMOEQ 100MG BASETABLET / ORALRLD, RS2018-11-215d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N210656-001DAURISMOEQ 25MG BASETABLET / ORALRLD2018-11-214b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N210656-002DAURISMOEQ 100MG BASETABLET / ORALRLD, RS2018-11-214b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N210656-001DAURISMOEQ 25MG BASETABLET / ORALRLD2018-11-2174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N210656-002DAURISMOEQ 100MG BASETABLET / ORALRLD, RS2018-11-2174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N210656-001DAURISMOEQ 25MG BASETABLET / ORALRLD2018-11-21bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N210656-002DAURISMOEQ 100MG BASETABLET / ORALRLD, RS2018-11-21bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N210656-001DAURISMOEQ 25MG BASETABLET / ORALRLD2018-11-21782e0a99824c…
2021-12-28 21:50 UTC2021-12N210656-002DAURISMOEQ 100MG BASETABLET / ORALRLD, RS2018-11-21782e0a99824c…

Observed Orange Book patent history#

Patent history page 1 of 9 · 336 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-02-19 14:30 UTC2026-02N210656-00184315972028-06-29Drug product2018-12-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02N210656-00181484012029-04-14Drug substance, Drug product2018-12-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02N210656-001104147482036-04-13Drug substance, Drug product2019-10-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02N210656-001111680662036-04-13U-32542021-12-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02N210656-001118913722036-04-13U-32542024-03-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02N210656-00284315972028-06-29Drug product2018-12-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02N210656-00281484012029-04-14Drug substance, Drug product2018-12-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02N210656-002104147482036-04-13Drug substance, Drug product2019-10-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02N210656-002111680662036-04-13U-32542021-12-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02N210656-002118913722036-04-13U-32542024-03-06011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N210656-00184315972028-06-29Drug product2018-12-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N210656-00181484012031-01-30Drug substance, Drug product2018-12-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N210656-001104147482036-04-13Drug substance, Drug product2019-10-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N210656-001111680662036-04-13U-32542021-12-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N210656-001118913722036-04-13U-32542024-03-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N210656-00284315972028-06-29Drug product2018-12-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N210656-00281484012031-01-30Drug substance, Drug product2018-12-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N210656-002104147482036-04-13Drug substance, Drug product2019-10-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N210656-002111680662036-04-13U-32542021-12-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N210656-002118913722036-04-13U-32542024-03-0631067a03dcf5…
2025-08-23 18:47 UTC2025-08N210656-00184315972028-06-29Drug product2018-12-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08N210656-00181484012031-01-30Drug substance, Drug product2018-12-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08N210656-001104147482036-04-13Drug substance, Drug product2019-10-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08N210656-001111680662036-04-13U-32542021-12-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08N210656-001118913722036-04-13U-32542024-03-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08N210656-00284315972028-06-29Drug product2018-12-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08N210656-00281484012031-01-30Drug substance, Drug product2018-12-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08N210656-002104147482036-04-13Drug substance, Drug product2019-10-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08N210656-002111680662036-04-13U-32542021-12-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08N210656-002118913722036-04-13U-32542024-03-066a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N210656-00184315972028-06-29Drug product2018-12-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N210656-00181484012031-01-30Drug substance, Drug product2018-12-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N210656-001104147482036-04-13Drug substance, Drug product2019-10-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N210656-001111680662036-04-13U-32542021-12-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N210656-001118913722036-04-13U-32542024-03-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N210656-00284315972028-06-29Drug product2018-12-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N210656-00281484012031-01-30Drug substance, Drug product2018-12-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N210656-002104147482036-04-13Drug substance, Drug product2019-10-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N210656-002111680662036-04-13U-32542021-12-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N210656-002118913722036-04-13U-32542024-03-06fd3edfee7708…

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N210656-001ODE-2242025-11-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N210656-002ODE-2242025-11-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08N210656-001ODE-2242025-11-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08N210656-002ODE-2242025-11-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N210656-001ODE-2242025-11-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N210656-002ODE-2242025-11-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N210656-001ODE-2242025-11-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N210656-002ODE-2242025-11-21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N210656-001ODE-2242025-11-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N210656-002ODE-2242025-11-2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N210656-001ODE-2242025-11-212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N210656-002ODE-2242025-11-212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N210656-001ODE-2242025-11-215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N210656-002ODE-2242025-11-215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N210656-001ODE-2242025-11-21d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N210656-002ODE-2242025-11-21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N210656-001ODE-2242025-11-21d06236e962d9…
2024-10-29 15:01 UTC2024-10N210656-002ODE-2242025-11-21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N210656-001ODE-2242025-11-2179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N210656-002ODE-2242025-11-2179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N210656-001ODE-2242025-11-21301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N210656-002ODE-2242025-11-21301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N210656-001ODE-2242025-11-211e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N210656-002ODE-2242025-11-211e350fbaab3a…
2024-05-31 18:47 UTC2024-05N210656-001ODE-2242025-11-218072bd15b7f6…
2024-05-31 18:47 UTC2024-05N210656-002ODE-2242025-11-218072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N210656-001NCE2023-11-215c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N210656-001ODE-2242025-11-215c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N210656-002NCE2023-11-215c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N210656-002ODE-2242025-11-215c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N210656-001NCE2023-11-215d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N210656-001ODE-2242025-11-215d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N210656-002NCE2023-11-215d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N210656-002ODE-2242025-11-215d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N210656-001NCE2023-11-214b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N210656-001ODE-2242025-11-214b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N210656-002NCE2023-11-214b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N210656-002ODE-2242025-11-214b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N210656-001NCE2023-11-2174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N210656-001ODE-2242025-11-2174a2ff9319b5…

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DaurismoGLASDEGIBPfizer Laboratories Div Pfizer Inc204a6f7e-c9a4-472b-abd2-9527bda64d172025-12-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 210656
application number: NDA210656
ndc (product): 0069-0298
ndc (product): 0069-1531

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0069-0298DaurismoglasdegibPfizer Laboratories Div Pfizer IncNDACurrent
0069-0298DaurismoglasdegibPfizer Laboratories Div Pfizer IncNDACurrent
0069-0298DaurismoglasdegibPfizer Laboratories Div Pfizer IncNDACurrent
0069-0298DaurismoglasdegibPfizer Laboratories Div Pfizer IncNDACurrent
0069-0298DaurismoglasdegibPfizer Laboratories Div Pfizer IncNDACurrent
0069-1531DaurismoglasdegibPfizer Laboratories Div Pfizer IncNDACurrent
0069-1531DaurismoglasdegibPfizer Laboratories Div Pfizer IncNDACurrent
0069-1531DaurismoglasdegibPfizer Laboratories Div Pfizer IncNDACurrent
0069-1531DaurismoglasdegibPfizer Laboratories Div Pfizer IncNDACurrent
0069-1531DaurismoglasdegibPfizer Laboratories Div Pfizer IncNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
73896SUPPL 2023-03-28
73895SUPPL 2023-03-28
73887SUPPL 2023-03-28
62215SUPPL2020-03-20
62214SUPPL2020-03-20
62212SUPPL2020-03-20
62211SUPPL2020-03-20
62210SUPPL2020-03-20
62209SUPPL2020-03-20
56753ORIG2018-12-17
56700ORIG2018-12-10
56533ORIG2018-11-21