Home Applications 218092 Application 218092
Type ANDA
Sponsor GLENMARK SPECLT Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ESOMEPRAZOLE MAGNESIUM ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE;ORAL EQ 20MG BASE No No
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A218092-001 ESOMEPRAZOLE MAGNESIUM ESOMEPRAZOLE MAGNESIUM EQ 20MG BASE CAPSULE, DELAYED RELEASE / ORAL 2024-06-11
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 A218092-001 ESOMEPRAZOLE MAGNESIUM EQ 20MG BASE CAPSULE, DELAYED RELEASE / ORAL 2024-06-11 84e616aacf4f…2026-08-18 06:07:40 2026-07 A218092-001 ESOMEPRAZOLE MAGNESIUM EQ 20MG BASE CAPSULE, DELAYED RELEASE / ORAL 2024-06-11 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A218092-001 ESOMEPRAZOLE MAGNESIUM EQ 20MG BASE CAPSULE, DELAYED RELEASE / ORAL 2024-06-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218092-001 ESOMEPRAZOLE MAGNESIUM EQ 20MG BASE CAPSULE, DELAYED RELEASE / ORAL 2024-06-11 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A218092-001 ESOMEPRAZOLE MAGNESIUM EQ 20MG BASE CAPSULE, DELAYED RELEASE / ORAL 2024-06-11 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A218092-001 ESOMEPRAZOLE MAGNESIUM EQ 20MG BASE CAPSULE, DELAYED RELEASE / ORAL 2024-06-11 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A218092-001 ESOMEPRAZOLE MAGNESIUM EQ 20MG BASE CAPSULE, DELAYED RELEASE / ORAL 2024-06-11 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A218092-001 ESOMEPRAZOLE MAGNESIUM EQ 20MG BASE CAPSULE, DELAYED RELEASE / ORAL 2024-06-11 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A218092-001 ESOMEPRAZOLE MAGNESIUM EQ 20MG BASE CAPSULE, DELAYED RELEASE / ORAL 2024-06-11 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A218092-001 ESOMEPRAZOLE MAGNESIUM EQ 20MG BASE CAPSULE, DELAYED RELEASE / ORAL 2024-06-11 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A218092-001 ESOMEPRAZOLE MAGNESIUM EQ 20MG BASE CAPSULE, DELAYED RELEASE / ORAL 2024-06-11 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A218092-001 ESOMEPRAZOLE MAGNESIUM EQ 20MG BASE CAPSULE, DELAYED RELEASE / ORAL 2024-06-11 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A218092-001 ESOMEPRAZOLE MAGNESIUM EQ 20MG BASE CAPSULE, DELAYED RELEASE / ORAL 2024-06-11 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A218092-001 ESOMEPRAZOLE MAGNESIUM EQ 20MG BASE CAPSULE, DELAYED RELEASE / ORAL 2024-06-11 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A218092-001 ESOMEPRAZOLE MAGNESIUM EQ 20MG BASE CAPSULE, DELAYED RELEASE / ORAL 2024-06-11 1e350fbaab3a…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218092-001 ESOMEPRAZOLE MAGNESIUM EQ 20MG BASE CAPSULE, DELAYED RELEASE / ORAL 2024-06-11 a50c72e98297…
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 7 of 9 · 170 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Esomeprazole Magnesium ESOMEPRAZOLE MAGNESIUM Dr. Reddy's Laboratories Inc fab0b1fa-cf56-d97c-f026-1754cf5b792c 2024-07-08 Warnings Name fallback brand name: Esomeprazole Magnesium generic name: ESOMEPRAZOLE MAGNESIUM Esomeprazole Magnesium ESOMEPRAZOLE MAGNESIUM WALGREEN CO. 179b23c4-2a6c-f658-e063-6394a90a82b3 2024-07-08 Warnings Name fallback brand name: Esomeprazole Magnesium generic name: ESOMEPRAZOLE MAGNESIUM Esomeprazole Magnesium ESOMEPRAZOLE MAGNESIUM Cardinal Health 90df7bbb-c55e-4a01-90b7-c118b65617a9 2024-06-27 Warnings Name fallback brand name: Esomeprazole Magnesium generic name: ESOMEPRAZOLE MAGNESIUM Esomeprazole Magnesium ESOMEPRAZOLE MAGNESIUM Dr. Reddy's Laboratories Inc fca35363-7d27-b8b3-14c0-56f603652053 2024-06-24 Warnings Name fallback brand name: Esomeprazole Magnesium generic name: ESOMEPRAZOLE MAGNESIUM Esomeprazole Magnesium ESOMEPRAZOLE MAGNESIUM LITTLE PHARMA, INC. e45621ea-cc15-4a8e-98d2-d10ab424a45e 2024-06-17 Warnings Name fallback brand name: Esomeprazole Magnesium generic name: ESOMEPRAZOLE MAGNESIUM Esomeprazole magnesium ESOMEPRAZOLE MAGNESIUM Rising Pharma Holdings, Inc. 83fa2aab-f00d-4428-b961-d960247d7169 2024-06-14 Warnings, Adverse reactions Name fallback brand name: Esomeprazole magnesium generic name: ESOMEPRAZOLE MAGNESIUM esomeprazole magnesium ESOMEPRAZOLE MAGNESIUM Bryant Ranch Prepack 925cee78-83af-480f-838d-8ba97ac6b1e3 2024-05-20 Warnings, Adverse reactions Name fallback brand name: esomeprazole magnesium generic name: ESOMEPRAZOLE MAGNESIUM esomeprazole magnesium ESOMEPRAZOLE MAGNESIUM Bryant Ranch Prepack 596e1cf8-dc6e-48b0-95ae-b463955870f7 2024-05-20 Warnings, Adverse reactions Name fallback brand name: esomeprazole magnesium generic name: ESOMEPRAZOLE MAGNESIUM ESOMEPRAZOLE MAGNESIUM ESOMEPRAZOLE MAGNESIUM Cipla USA Inc. 180490d1-c165-4bb9-96b1-12e727256e4e 2024-05-16 Warnings, Adverse reactions Name fallback brand name: ESOMEPRAZOLE MAGNESIUM generic name: ESOMEPRAZOLE MAGNESIUM Nexium 24HR ESOMEPRAZOLE MAGNESIUM A-S Medication Solutions d56b330a-4355-4636-9d26-c592f67cea56 2024-05-14 Warnings Name fallback generic name: ESOMEPRAZOLE MAGNESIUM Esomeprazole magnesium ESOMEPRAZOLE MAGNESIUM Cipla USA Inc. c1319da6-bf0d-4dd6-a713-1677bfbfbdae 2024-05-13 Warnings, Adverse reactions Name fallback brand name: Esomeprazole magnesium generic name: ESOMEPRAZOLE MAGNESIUM Esomeprazole Magnesium ESOMEPRAZOLE MAGNESIUM CVS Pharmacy, Inc. d226cda0-5cdb-4e2d-a865-530a8f09a095 2024-04-27 Warnings Name fallback brand name: Esomeprazole Magnesium generic name: ESOMEPRAZOLE MAGNESIUM Esomeprazole Magnesium ESOMEPRAZOLE MAGNESIUM INNOVUS PHARMACEUTICALS, INC. a32039b7-8475-4ec5-abaf-07f9aee3954b 2024-04-27 Warnings Name fallback brand name: Esomeprazole Magnesium generic name: ESOMEPRAZOLE MAGNESIUM Esomeprazole Magnesium ESOMEPRAZOLE MAGNESIUM Family Dollar Stores, LLC f86ba9b5-736e-b279-e053-6394a90acf7c 2024-04-27 Warnings Name fallback brand name: Esomeprazole Magnesium generic name: ESOMEPRAZOLE MAGNESIUM Esomeprazole Magnesium ESOMEPRAZOLE MAGNESIUM Ahold U.S.A., Inc, 7bb719a0-9836-6752-e053-2a91aa0a2f48 2024-04-27 Warnings Name fallback brand name: Esomeprazole Magnesium generic name: ESOMEPRAZOLE MAGNESIUM Esomeprazole Magnesium ESOMEPRAZOLE MAGNESIUM Better Living Brands LLC ee6e3f66-4eb9-4094-afcc-aaa020942b39 2024-04-27 Warnings Name fallback brand name: Esomeprazole Magnesium generic name: ESOMEPRAZOLE MAGNESIUM Esomeprazole Magnesium ESOMEPRAZOLE MAGNESIUM Best Choice 56120925-28e3-4e6c-b54d-490d7460984f 2024-04-27 Warnings Name fallback brand name: Esomeprazole Magnesium generic name: ESOMEPRAZOLE MAGNESIUM Esomeprazole Magnesium ESOMEPRAZOLE MAGNESIUM WALGREEN CO. f9e10472-c6a3-402c-b6a2-f8700ad73e9f 2024-04-27 Warnings Name fallback brand name: Esomeprazole Magnesium generic name: ESOMEPRAZOLE MAGNESIUM Esomeprazole Magnesium ESOMEPRAZOLE MAGNESIUM Aurohealth LLC f9a5431a-ea03-441f-9064-6e7f30b61674 2024-04-27 Warnings Name fallback brand name: Esomeprazole Magnesium generic name: ESOMEPRAZOLE MAGNESIUM Esomeprazole Magnesium ESOMEPRAZOLE MAGNESIUM Wal-Mart Stores, Inc. c14f096d-ea1f-4539-8ad0-bb9907745cfc 2024-04-27 Warnings Name fallback brand name: Esomeprazole Magnesium generic name: ESOMEPRAZOLE MAGNESIUM
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.