Application 217264

Type
ANDA
Sponsor
MARKSANS PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ESOMEPRAZOLE MAGNESIUMESOMEPRAZOLE MAGNESIUMCAPSULE, DELAYED RELEASE;ORALEQ 20MG BASENoNo

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

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
A217264-001ESOMEPRAZOLE MAGNESIUMESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2023-09-29

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
2026-02-19 14:30 UTC2026-02A217264-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2023-09-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217264-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2023-09-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08A217264-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2023-09-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217264-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2023-09-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A217264-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2023-09-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A217264-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2023-09-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A217264-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2023-09-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A217264-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2023-09-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A217264-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2023-09-29d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A217264-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2023-09-29d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A217264-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2023-09-2979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A217264-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2023-09-29301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A217264-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2023-09-291e350fbaab3a…
2024-05-31 18:47 UTC2024-05A217264-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2023-09-298072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A217264-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2023-09-296a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A217264-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2023-09-291c564ffb4f44…
2023-12-20 04:57 UTC2023-12A217264-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2023-09-29ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A217264-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2023-09-29a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A217264-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2023-09-299b2671bbb829…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217264-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2023-09-29a50c72e98297…

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 · 9 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
24 HOUR Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMGrocery Outlet, Inc.4467134e-018f-2ad6-e063-6294a90a42bb2026-06-05WarningsExact identifier
application applno (ANDA): 217264
application number: ANDA217264
Esomeprazole Magnesium Delayed-Release 20 mg (OTC)ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE 20 MG (OTC)MARKSANS PHARMA LIMITED6a21f085-b60b-49b7-8098-99ccdc43dde32026-06-01WarningsExact identifier
application applno (ANDA): 217264
application number: ANDA217264
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMH-E-B448bd1ea-baa2-7d6b-e063-6394a90ae5e02026-04-29WarningsExact identifier
application applno (ANDA): 217264
application number: ANDA217264
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMWalmart Inc.3863bc2c-3120-ad92-e063-6394a90abb202025-09-19WarningsExact identifier
application applno (ANDA): 217264
application number: ANDA217264
Esomeprazole Magnesium Delayed ReleaseESOMEPRAZOLE MAGNESIUMWALGREENS2fa5d747-a014-2475-e063-6294a90ab9182025-04-21WarningsExact identifier
application applno (ANDA): 217264
application number: ANDA217264
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMBETTER LIVING BRANDS LLC.f2c06861-0324-93ed-e053-2995a90a59022024-04-20WarningsExact identifier
application applno (ANDA): 217264
application number: ANDA217264
Esomeprazole Magnesium Delayed-Release Capsules, 20 mgESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE CAPSULES, 20 MGMARKSANS PHARMA LIMITED32f26c74-3052-4a69-9dc7-d18f9d761a8b2024-03-18WarningsExact identifier
application applno (ANDA): 217264
application number: ANDA217264
Esomeprazole magnesiumESOMEPRAZOLE MAGNESIUMTIME CAP LABORATORIES, INC.08acf79f-f50d-8416-e063-6294a90a27042023-11-23WarningsExact identifier
application applno (ANDA): 217264
application number: ANDA217264
Esomeprazole magnesiumESOMEPRAZOLE MAGNESIUMBETTER LIVING BRANDS, LLCeb4c1cac-89a2-c040-e053-2995a90ae1cd2023-11-17WarningsExact identifier
application applno (ANDA): 217264
application number: ANDA217264