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 42.

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
2026-08-18 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 · 74 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
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…
2021-12-28 21:50 UTC2021-12N214278-001100764942036-12-08Drug product2020-11-18782e0a99824c…
2021-12-28 21:50 UTC2021-12N214278-001108354882036-12-08Drug product2020-11-18782e0a99824c…

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 3 · 43 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Esomeprazole MagnesiumESOMEPRAZOLECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED19fa87e4-8225-4969-9857-1bf43db4427b2026-07-31WarningsName fallback
generic name: ESOMEPRAZOLE
esomeprazole magnesiumESOMEPRAZOLERite Aid Corporation6996642f-a63e-4be9-aefd-0634e9914c2b2026-07-07WarningsName fallback
generic name: ESOMEPRAZOLE
Basic Care Esomeprazole MagnesiumESOMEPRAZOLEAmazon.com Services LLC42dd2e93-776c-4f49-b590-afc7dab6ef2f2026-06-17WarningsName fallback
generic name: ESOMEPRAZOLE
EsomeprazoleESOMEPRAZOLE MAGNESIUMOhm Laboratories Inc.e6d19b0a-44a8-42fe-8a6c-717ecb3ac1c42026-06-06WarningsName fallback
brand name: Esomeprazole
good sense esomeprazole magnesiumESOMEPRAZOLEL. Perrigo Companyf13088de-6841-453e-acb0-08bbdf9529d12026-05-20WarningsName fallback
generic name: ESOMEPRAZOLE
RIOPANESOMEPRAZOLEOPMX LLC4c37280d-25b6-ad2f-e063-6394a90a0b9d2026-03-24WarningsName fallback
generic name: ESOMEPRAZOLE
EQUATE ESOMEPRAZOLE MAGNESIUMESOMEPRAZOLEWALMART INC.ce5f2915-327d-4a91-b7fd-e399664a250f2026-03-19WarningsName fallback
generic name: ESOMEPRAZOLE
Foster and Thrive Acid ReducerESOMEPRAZOLEStrategic Sourcing Services LLC32933772-c0ef-46ad-84e5-d70218bcc8662026-03-07WarningsName fallback
generic name: ESOMEPRAZOLE
members mark esomeprazole magnesiumESOMEPRAZOLESam's West Inc87913038-4b90-40a0-bce5-2d368bd5758c2026-02-07WarningsName fallback
generic name: ESOMEPRAZOLE
esomeprazole magnesiumESOMEPRAZOLEHyVee Incb0968243-171e-428a-b692-740e0c05a0fc2026-01-29WarningsName fallback
generic name: ESOMEPRAZOLE
equate esomeprazole magnesiumESOMEPRAZOLEWal-Mart Stores Incaaafc536-f846-4019-a629-b52b3f36e6822026-01-19WarningsName fallback
generic name: ESOMEPRAZOLE
berkley and jensen heartburn treatmentESOMEPRAZOLEBJWC2369c948-d46f-4ace-bc51-47477631bc432026-01-19WarningsName fallback
generic name: ESOMEPRAZOLE
EsomeprazoleESOMEPRAZOLE MAGNESIUMYYBA CORP0912d311-e26c-479d-9f13-ef0ac403e9b82025-11-19WarningsName fallback
brand name: Esomeprazole
careone esomeprazole magnesiumESOMEPRAZOLEAmerican Sales Company3f9a2747-8afd-4898-bbfb-5f379293137e2025-11-03WarningsName fallback
generic name: ESOMEPRAZOLE
Esomeprazole MagnesiumESOMEPRAZOLEPublix Super Markets Inc60554fd6-96d5-4e73-b676-332116caa8002025-09-29WarningsName fallback
generic name: ESOMEPRAZOLE
EsomeprazoleESOMEPRAZOLE MAGNESIUMCVSb68035d0-195a-41e8-9928-8b1bd57917c02025-09-15WarningsName fallback
brand name: Esomeprazole
leader esomeprazole magnesiumESOMEPRAZOLECardinal Health 110, LLC. dba Leaderc9472b82-d345-4531-bf07-bd55c94876ab2025-04-23WarningsName fallback
generic name: ESOMEPRAZOLE
esomeprazole magnesiumESOMEPRAZOLECVS Pharmacy6f1d75c1-3c0d-41c2-a625-1ee1bf642c322025-01-11WarningsName fallback
generic name: ESOMEPRAZOLE
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

Documents#

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