Application 214278

Type
NDA
Sponsor
Dexcel Pharma Technologies Ltd.

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ESOMEPRAZOLEESOMEPRAZOLETABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL20MGNoNo

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
N214278-001ESOMEPRAZOLE MAGNESIUMESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORALRLD2020-10-20

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N214278-001100764942036-12-08Drug product2020-11-18
N214278-001108354882036-12-08Drug product2020-11-18

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N214278-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORALRLD2020-10-2084e616aacf4f…
2026-08-18 06:07:402026-07N214278-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORALRLD2020-10-20caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N214278-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORALRLD2020-10-20011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N214278-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORALRLD2020-10-2031067a03dcf5…
2025-08-23 18:47 UTC2025-08N214278-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORALRLD2020-10-206a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N214278-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORALRLD2020-10-20fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N214278-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORALRLD2020-10-20b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N214278-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORALRLD2020-10-2003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N214278-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORALRLD2020-10-202680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N214278-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORALRLD2020-10-205bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N214278-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORALRLD2020-10-20d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N214278-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORALRLD2020-10-20d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N214278-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORALRLD2020-10-2079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N214278-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORALRLD2020-10-20301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N214278-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORALRLD2020-10-201e350fbaab3a…
2024-05-31 18:47 UTC2024-05N214278-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORALRLD2020-10-208072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N214278-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORALRLD2020-10-205c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N214278-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORALRLD2020-10-205d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N214278-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORALRLD2020-10-204b0b4de00fa7…
2022-03-09 01:35 UTC2022-03N214278-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORALRLD2020-10-20bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N214278-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORALRLD, RS2020-10-20782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N214278-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORALRLD, RS2020-10-2087673890dc5c…
2021-03-12 10:30 UTC2021-03N214278-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORALRLD, RS2020-10-205aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N214278-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORALRLD, RS2020-10-208869cabd3fbd…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N214278-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORALRLD2020-10-206a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N214278-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORALRLD2020-10-201c564ffb4f44…
2023-12-20 04:57 UTC2023-12N214278-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORALRLD2020-10-20ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N214278-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORALRLD2020-10-20a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N214278-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORALRLD2020-10-209b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N214278-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORALRLD2020-10-20a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N214278-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORALRLD2020-10-203f0d92c62455…
2023-05-13 08:27 UTC2023-05N214278-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORALRLD2020-10-20053a50430f4f…
2023-01-26 05:58 UTC2023-01N214278-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORALRLD2020-10-203bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N214278-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORALRLD2020-10-203a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N214278-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORALRLD2020-10-20f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N214278-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORALRLD2020-10-20e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N214278-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORALRLD2020-10-20cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N214278-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORALRLD2020-10-20a50c72e98297…

Observed Orange Book patent history#

Patent history page 1 of 2 · 76 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-09-14 22:38:342026-08N214278-001100764942036-12-08Drug product2020-11-1884e616aacf4f…
2026-09-14 22:38:342026-08N214278-001108354882036-12-08Drug product2020-11-1884e616aacf4f…
2026-08-18 06:07:402026-07N214278-001100764942036-12-08Drug product2020-11-18caaa826d4ba7…
2026-08-18 06:07:402026-07N214278-001108354882036-12-08Drug product2020-11-18caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N214278-001100764942036-12-08Drug product2020-11-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02N214278-001108354882036-12-08Drug product2020-11-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N214278-001100764942036-12-08Drug product2020-11-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N214278-001108354882036-12-08Drug product2020-11-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08N214278-001100764942036-12-08Drug product2020-11-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08N214278-001108354882036-12-08Drug product2020-11-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N214278-001100764942036-12-08Drug product2020-11-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N214278-001108354882036-12-08Drug product2020-11-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N214278-001100764942036-12-08Drug product2020-11-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N214278-001108354882036-12-08Drug product2020-11-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N214278-001100764942036-12-08Drug product2020-11-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N214278-001108354882036-12-08Drug product2020-11-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N214278-001100764942036-12-08Drug product2020-11-182680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N214278-001108354882036-12-08Drug product2020-11-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N214278-001100764942036-12-08Drug product2020-11-185bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N214278-001108354882036-12-08Drug product2020-11-185bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N214278-001100764942036-12-08Drug product2020-11-18d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N214278-001108354882036-12-08Drug product2020-11-18d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N214278-001100764942036-12-08Drug product2020-11-18d06236e962d9…
2024-10-29 15:01 UTC2024-10N214278-001108354882036-12-08Drug product2020-11-18d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N214278-001100764942036-12-08Drug product2020-11-1879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N214278-001108354882036-12-08Drug product2020-11-1879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N214278-001100764942036-12-08Drug product2020-11-18301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N214278-001108354882036-12-08Drug product2020-11-18301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N214278-001100764942036-12-08Drug product2020-11-181e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N214278-001108354882036-12-08Drug product2020-11-181e350fbaab3a…
2024-05-31 18:47 UTC2024-05N214278-001100764942036-12-08Drug product2020-11-188072bd15b7f6…
2024-05-31 18:47 UTC2024-05N214278-001108354882036-12-08Drug product2020-11-188072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N214278-001100764942036-12-08Drug product2020-11-185c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N214278-001108354882036-12-08Drug product2020-11-185c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N214278-001100764942036-12-08Drug product2020-11-185d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N214278-001108354882036-12-08Drug product2020-11-185d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N214278-001100764942036-12-08Drug product2020-11-184b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N214278-001108354882036-12-08Drug product2020-11-184b0b4de00fa7…
2022-03-09 01:35 UTC2022-03N214278-001100764942036-12-08Drug product2020-11-18bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N214278-001108354882036-12-08Drug product2020-11-18bb7c543d1eb4…

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 3 · 44 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
esomeprazoleESOMEPRAZOLEMacleods Pharmaceuticals Limitedd68c9247-91c7-4e0f-adc4-2cfa7446580f2024-11-30Warnings, Adverse reactionsName fallback
brand name: esomeprazole
generic name: ESOMEPRAZOLE
EsomeprazoleESOMEPRAZOLE MAGNESIUMINNOVUS PHARMACEUTICALS, INC.b3d10f0b-52af-408c-9b3d-f8f25f7c42bd2024-10-30WarningsName fallback
brand name: Esomeprazole
Good Sense Esomeprazole MagnesiumESOMEPRAZOLEL. Perrigo Company4a89b4b5-5c42-44ee-98a9-e26a237aaef72024-08-27WarningsName fallback
generic name: ESOMEPRAZOLE
DG Health Esomeprazole MagnesiumESOMEPRAZOLEDolgencorp Inc2b0e555d-3ed5-4ec4-82a6-855351c503b32024-08-02WarningsName fallback
generic name: ESOMEPRAZOLE
dg health esomeprazole magnesiumESOMEPRAZOLEDolgencorp, LLC8f974698-ce9c-4ffb-b77e-9bad2c2ee2a12024-08-01WarningsName fallback
generic name: ESOMEPRAZOLE
up and up esomeprazole magnesiumESOMEPRAZOLETarget Corporation717e5d5b-4bf7-415e-b259-44056bc96d8b2024-08-01WarningsName fallback
generic name: ESOMEPRAZOLE
kirkland signature esomeprazole magnesiumESOMEPRAZOLECostco Wholesale Company4a87d5d5-c98b-4dc5-81be-50183342b0472024-08-01WarningsName fallback
generic name: ESOMEPRAZOLE
Good Neighbor Pharmacy Esomeprazole MagnesiumESOMEPRAZOLEAmerisource Bergenb596055c-98b2-47b1-b174-ae7ad3ba97ee2024-07-30WarningsName fallback
generic name: ESOMEPRAZOLE
Exchange Select Esomeprazole MagnesiumESOMEPRAZOLEArmy & Air Force Exchange Service5fa9089f-90d1-48b6-bb79-c6171eeeaa032024-07-26WarningsName fallback
generic name: ESOMEPRAZOLE
signature care esomeprazole magnesiumESOMEPRAZOLESafeway238b27e3-6993-4213-b7eb-062309398d1b2024-07-26WarningsName fallback
generic name: ESOMEPRAZOLE
good sense esomeprazole magnesiumESOMEPRAZOLEL. Perrigo Companye54f2cc9-1d5f-4f0a-8bcf-bd5b917d98ec2024-07-26WarningsName fallback
generic name: ESOMEPRAZOLE
Esomeprazole MagnesiumESOMEPRAZOLEH E B0d08dd06-8df6-43ff-9033-8eebd215bec12024-07-26WarningsName fallback
generic name: ESOMEPRAZOLE
signature care esomeprazole magnesiumESOMEPRAZOLESafeway972bb479-7146-454d-ace4-f9314f0e584e2024-07-26WarningsName fallback
generic name: ESOMEPRAZOLE
basic care esomeprazole magnesiumESOMEPRAZOLEAmazon.com Services LLC0b115351-318c-4bd9-935c-704a09bcdf522024-07-25WarningsName fallback
generic name: ESOMEPRAZOLE
esomeprazole magnesiumESOMEPRAZOLEKroger Companyda02c079-ed18-4896-896d-0489c8f435542024-07-25WarningsName fallback
generic name: ESOMEPRAZOLE
esomeprazole magnesiumESOMEPRAZOLEMeijer Distribution Inc126c269b-260d-40f4-879d-169c09251c672024-07-25WarningsName fallback
generic name: ESOMEPRAZOLE
dg health esomeprazole magnesiumESOMEPRAZOLEDolgencorp Incd5a842f3-d21b-4ddf-87f1-e44daf5cfe052024-05-08WarningsName fallback
generic name: ESOMEPRAZOLE
esomeprazole magnesiumESOMEPRAZOLEMeijer, Inc.8799c88f-dafb-4be6-b279-a54d916162fe2024-03-25WarningsName fallback
generic name: ESOMEPRAZOLE
esomeprazole magnesiumESOMEPRAZOLEWalgreen Companyd6a55d37-c53b-4451-859b-4dbe1988eb9d2024-03-21WarningsName fallback
generic name: ESOMEPRAZOLE
basic care esomeprazole magnesiumESOMEPRAZOLEAmazon.com Services LLC2466913b-7292-4dfd-8ac9-429256faacee2024-02-13WarningsName fallback
generic name: ESOMEPRAZOLE

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
71087SUPPL2022-05-17
71058SUPPL2022-05-12
68565SUPPL2021-09-09
66206ORIG2021-02-12
64966ORIG2020-10-21