Application 208056

Type
NDA
Sponsor
TAKEDA PHARMS USA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DEXILANT SOLUTABDEXLANSOPRAZOLETABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL30MGYesNo

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N208056-001DEXILANT SOLUTABDEXLANSOPRAZOLE30MGTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORALRLD2016-01-26

Orange Book patents#

Current patent rows page 1 of 1 · 7 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N208056-00184611872026-01-17Drug product2016-02-25
N208056-00192380292026-01-17Drug product2016-02-25
N208056-00190119262026-02-24Drug product2016-02-25
N208056-0018461187*PED2026-07-17Pediatric extension
N208056-00188712732028-01-11Drug product2016-02-25
N208056-0018871273*PED2028-07-11Pediatric extension
N208056-00192419102029-03-10Drug 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 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N208056-001DEXILANT SOLUTAB30MGTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORALRLD2016-01-2684e616aacf4f…
2026-08-18 06:07:402026-07N208056-001DEXILANT SOLUTAB30MGTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORALRLD2016-01-26caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N208056-001DEXILANT SOLUTAB30MGTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORALRLD2016-01-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N208056-001DEXILANT SOLUTAB30MGTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORALRLD2016-01-2631067a03dcf5…
2025-08-23 18:47 UTC2025-08N208056-001DEXILANT SOLUTAB30MGTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORALRLD2016-01-266a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N208056-001DEXILANT SOLUTAB30MGTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORALRLD2016-01-26fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N208056-001DEXILANT SOLUTAB30MGTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORALRLD2016-01-26b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N208056-001DEXILANT SOLUTAB30MGTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORALRLD2016-01-2603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N208056-001DEXILANT SOLUTAB30MGTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORALRLD2016-01-262680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N208056-001DEXILANT SOLUTAB30MGTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORALRLD2016-01-265bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N208056-001DEXILANT SOLUTAB30MGTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORALRLD2016-01-26d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N208056-001DEXILANT SOLUTAB30MGTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORALRLD2016-01-26d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N208056-001DEXILANT SOLUTAB30MGTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORALRLD2016-01-2679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N208056-001DEXILANT SOLUTAB30MGTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORALRLD2016-01-26301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N208056-001DEXILANT SOLUTAB30MGTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORALRLD2016-01-261e350fbaab3a…
2024-05-31 18:47 UTC2024-05N208056-001DEXILANT SOLUTAB30MGTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORALRLD2016-01-268072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N208056-001DEXILANT SOLUTAB30MGTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORALRLD2016-01-265c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N208056-001DEXILANT SOLUTAB30MGTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORALRLD2016-01-265d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N208056-001DEXILANT SOLUTAB30MGTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORALRLD2016-01-264b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N208056-001DEXILANT SOLUTAB30MGTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORALRLD2016-01-2674a2ff9319b5…
2022-03-09 01:35 UTC2022-03N208056-001DEXILANT SOLUTAB30MGTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORALRLD2016-01-26bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N208056-001DEXILANT SOLUTAB30MGTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORALRLD2016-01-26782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N208056-001DEXILANT SOLUTAB30MGTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORALRLD2016-01-2687673890dc5c…
2021-03-12 10:30 UTC2021-03N208056-001DEXILANT SOLUTAB30MGTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORALRLD2016-01-265aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N208056-001DEXILANT SOLUTAB30MGTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORALRLD2016-01-268869cabd3fbd…
2020-11-12 02:37 UTC2020-11N208056-001DEXILANT SOLUTAB30MGTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORALRLD2016-01-26c0c555d07b60…
2019-12-14 00:12 UTC2019-12N208056-001DEXILANT SOLUTAB30MGTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORALRLD2016-01-263f01610625f2…
2019-09-15 20:21 UTC2019-09N208056-001DEXILANT SOLUTAB30MGTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORALRLD2016-01-26b00525d2431f…
2019-07-19 19:46 UTC2019-07N208056-001DEXILANT SOLUTAB30MGTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORALRLD2016-01-26ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N208056-001DEXILANT SOLUTAB30MGTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORALRLD2016-01-266a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N208056-001DEXILANT SOLUTAB30MGTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORALRLD2016-01-261c564ffb4f44…
2023-12-20 04:57 UTC2023-12N208056-001DEXILANT SOLUTAB30MGTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORALRLD2016-01-26ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N208056-001DEXILANT SOLUTAB30MGTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORALRLD2016-01-26a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N208056-001DEXILANT SOLUTAB30MGTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORALRLD2016-01-269b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N208056-001DEXILANT SOLUTAB30MGTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORALRLD2016-01-26a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N208056-001DEXILANT SOLUTAB30MGTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORALRLD2016-01-263f0d92c62455…
2023-05-13 08:27 UTC2023-05N208056-001DEXILANT SOLUTAB30MGTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORALRLD2016-01-26053a50430f4f…
2023-01-26 05:58 UTC2023-01N208056-001DEXILANT SOLUTAB30MGTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORALRLD2016-01-263bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N208056-001DEXILANT SOLUTAB30MGTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORALRLD2016-01-263a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N208056-001DEXILANT SOLUTAB30MGTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORALRLD2016-01-26f41ea6bd6efb…

Observed Orange Book patent history#

Patent history page 1 of 13 · 510 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-09-14 22:38:342026-08N208056-00184611872026-01-17Drug product2016-02-2584e616aacf4f…
2026-09-14 22:38:342026-08N208056-00192380292026-01-17Drug product2016-02-2584e616aacf4f…
2026-09-14 22:38:342026-08N208056-00190119262026-02-24Drug product2016-02-2584e616aacf4f…
2026-09-14 22:38:342026-08N208056-0018461187*PED2026-07-17Pediatric extension84e616aacf4f…
2026-09-14 22:38:342026-08N208056-00188712732028-01-11Drug product2016-02-2584e616aacf4f…
2026-09-14 22:38:342026-08N208056-0018871273*PED2028-07-11Pediatric extension84e616aacf4f…
2026-09-14 22:38:342026-08N208056-00192419102029-03-10Drug product84e616aacf4f…
2026-08-18 06:07:402026-07N208056-00184611872026-01-17Drug product2016-02-25caaa826d4ba7…
2026-08-18 06:07:402026-07N208056-00192380292026-01-17Drug product2016-02-25caaa826d4ba7…
2026-08-18 06:07:402026-07N208056-00190119262026-02-24Drug product2016-02-25caaa826d4ba7…
2026-08-18 06:07:402026-07N208056-0018461187*PED2026-07-17Pediatric extensioncaaa826d4ba7…
2026-08-18 06:07:402026-07N208056-00188712732028-01-11Drug product2016-02-25caaa826d4ba7…
2026-08-18 06:07:402026-07N208056-0018871273*PED2028-07-11Pediatric extensioncaaa826d4ba7…
2026-08-18 06:07:402026-07N208056-00192419102029-03-10Drug productcaaa826d4ba7…
2026-02-19 14:30 UTC2026-02N208056-00184611872026-01-17Drug product2016-02-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02N208056-00192380292026-01-17Drug product2016-02-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02N208056-00190119262026-02-24Drug product2016-02-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02N208056-0018461187*PED2026-07-17Pediatric extension011fe1cb6892…
2026-02-19 14:30 UTC2026-02N208056-00188712732028-01-11Drug product2016-02-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02N208056-0018871273*PED2028-07-11Pediatric extension011fe1cb6892…
2026-02-19 14:30 UTC2026-02N208056-00192419102029-03-10Drug product011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N208056-00184611872026-01-17Drug product2016-02-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N208056-00192380292026-01-17Drug product2016-02-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N208056-00190119262026-02-24Drug product2016-02-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N208056-0018461187*PED2026-07-17Pediatric extension31067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N208056-00188712732028-01-11Drug product2016-02-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N208056-0018871273*PED2028-07-11Pediatric extension31067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N208056-00192419102029-03-10Drug product31067a03dcf5…
2025-08-23 18:47 UTC2025-08N208056-00184611872026-01-17Drug product2016-02-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08N208056-00192380292026-01-17Drug product2016-02-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08N208056-00190119262026-02-24Drug product2016-02-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08N208056-0018461187*PED2026-07-17Pediatric extension6a471c1ec25d…
2025-08-23 18:47 UTC2025-08N208056-00188712732028-01-11Drug product2016-02-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08N208056-0018871273*PED2028-07-11Pediatric extension6a471c1ec25d…
2025-08-23 18:47 UTC2025-08N208056-00192419102029-03-10Drug product6a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N208056-00184611872026-01-17Drug product2016-02-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N208056-00192380292026-01-17Drug product2016-02-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N208056-00190119262026-02-24Drug product2016-02-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N208056-0018461187*PED2026-07-17Pediatric extensionfd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N208056-00188712732028-01-11Drug product2016-02-25fd3edfee7708…

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 · 15 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dexlansoprazole delayed releaseDEXLANSOPRAZOLEAphena Pharma Solutions - Tennessee, LLC59e0c5d7-12e9-b5d7-e063-6394a90a73662026-08-25Warnings, Adverse reactionsName fallback
generic name: DEXLANSOPRAZOLE
Dexlansoprazole delayed releaseDEXLANSOPRAZOLEGolden State Medical Supply, Inc.f799b9b6-ba79-f335-e053-6294a90aaa682026-06-17Warnings, Adverse reactionsName fallback
generic name: DEXLANSOPRAZOLE
Dexlansoprazole delayed releaseDEXLANSOPRAZOLEBryant Ranch Prepackdcfe880a-b96d-4a3c-aa21-3998d0bcfe9e2026-06-16Warnings, Adverse reactionsName fallback
generic name: DEXLANSOPRAZOLE
Dexlansoprazole delayed releaseDEXLANSOPRAZOLEUpsher-Smith Laboratories, LLC8dca4887-c75a-4021-8564-b704e9e1fa3e2026-05-08Warnings, Adverse reactionsName fallback
generic name: DEXLANSOPRAZOLE
DexlansoprazoleDEXLANSOPRAZOLEPar Health USA, LLCd7452a26-db20-42fc-868a-a3e3606ca8952026-04-13Warnings, Adverse reactionsName fallback
generic name: DEXLANSOPRAZOLE
Dexlansoprazole delayed releaseDEXLANSOPRAZOLEBryant Ranch Prepack31d3d485-5f87-4405-b940-490fa4ccf9cc2026-02-09Warnings, Adverse reactionsName fallback
generic name: DEXLANSOPRAZOLE
DexlansoprazoleDEXLANSOPRAZOLEAlembic Pharmaceuticals Limited24c33ba6-bf47-434e-903e-f7ced98e030e2025-11-19Warnings, Adverse reactionsName fallback
generic name: DEXLANSOPRAZOLE
DexlansoprazoleDEXLANSOPRAZOLEAlembic Pharmaceuticals Inc.f9607c88-03b7-46c6-8b88-84f01dcf22212025-11-14Warnings, Adverse reactionsName fallback
generic name: DEXLANSOPRAZOLE
DexilantDEXLANSOPRAZOLETakeda Pharmaceuticals America, Inc.9819f033-3bbe-442e-8e92-45fec77b237d2025-02-17Warnings, Adverse reactionsName fallback
generic name: DEXLANSOPRAZOLE
DexlansoprazoleDEXLANSOPRAZOLEA-S Medication Solutionsfc3de800-bfad-4e2f-b664-d58a67550b2f2024-11-13Warnings, Adverse reactionsName fallback
generic name: DEXLANSOPRAZOLE
DexlansoprazoleDEXLANSOPRAZOLEBryant Ranch Prepackcaad4ada-2cf9-4e12-99df-6ca4388cf0f62024-01-29Warnings, Adverse reactionsName fallback
generic name: DEXLANSOPRAZOLE
DexlansoprazoleDEXLANSOPRAZOLEBryant Ranch Prepack3ed69e5a-aa78-4118-aa32-59a10f80c9012024-01-05Warnings, Adverse reactionsName fallback
generic name: DEXLANSOPRAZOLE
Dexlansoprazole delayed releaseDEXLANSOPRAZOLEA-S Medication Solutions7c7698da-3cda-4301-ae93-02fb64b9c90d2023-11-22Warnings, Adverse reactionsName fallback
generic name: DEXLANSOPRAZOLE
DexlansoprazoleDEXLANSOPRAZOLEMylan Pharmaceuticals Inc.3f9699b5-7614-41cb-bd1d-ff02930e98f32023-07-15Warnings, Adverse reactionsName fallback
generic name: DEXLANSOPRAZOLE
Dexlansoprazole delayed releaseDEXLANSOPRAZOLEA-S Medication Solutions4f44e84f-6219-4445-a67d-df37d18b014d2023-06-06Warnings, Adverse reactionsName fallback
generic name: DEXLANSOPRAZOLE

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
49023ORIG2017-07-20
45872SUPPL2016-11-10
45668SUPPL2016-11-10
19980SUPPL2016-07-20
32884SUPPL2016-07-12
32883ORIG2016-02-03
19979ORIG2016-02-03