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 8 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 BETTER LIVING BRANDS LLC. f2c06861-0324-93ed-e053-2995a90a5902 2024-04-20 Warnings Name fallback brand name: Esomeprazole Magnesium generic name: ESOMEPRAZOLE MAGNESIUM Esomeprazole Magnesium ESOMEPRAZOLE MAGNESIUM Amerisource Bergen c94eb997-07d4-4d2e-b213-9a0d51db41c0 2024-03-29 Warnings Name fallback brand name: Esomeprazole Magnesium generic name: ESOMEPRAZOLE MAGNESIUM esomeprazole magnesium ESOMEPRAZOLE Meijer, Inc. 8799c88f-dafb-4be6-b279-a54d916162fe 2024-03-25 Warnings Name fallback brand name: esomeprazole magnesium esomeprazole magnesium ESOMEPRAZOLE Walgreen Company d6a55d37-c53b-4451-859b-4dbe1988eb9d 2024-03-21 Warnings Name fallback brand name: esomeprazole magnesium Nexium 24HR ESOMEPRAZOLE MAGNESIUM Haleon US Holdings LLC 4513934d-0cf0-40fc-a348-b4e75a33b094 2024-03-19 Warnings Name fallback generic name: ESOMEPRAZOLE MAGNESIUM Esomeprazole magnesium ESOMEPRAZOLE MAGNESIUM Ascend Laboratories, LLC f3d4a0d7-77fd-496e-8dfa-2b2dbace4bac 2024-02-29 Warnings, Adverse reactions Name fallback brand name: Esomeprazole magnesium generic name: ESOMEPRAZOLE MAGNESIUM Esomeprazole Magnesium ESOMEPRAZOLE MAGNESIUM Medsource Pharmaceuticals 1278cf6f-cc7a-462b-e063-6394a90a34e5 2024-02-28 Warnings, Adverse reactions Name fallback brand name: Esomeprazole Magnesium generic name: ESOMEPRAZOLE MAGNESIUM esomeprazole magnesium ESOMEPRAZOLE MAGNESIUM Proficient Rx LP 7b92ac4f-50c9-4061-b4a7-535a58cea8f6 2024-02-01 Warnings, Adverse reactions Name fallback brand name: esomeprazole magnesium generic name: ESOMEPRAZOLE MAGNESIUM Esomeprazole magnesium ESOMEPRAZOLE MAGNESIUM Zhejiang Yongtai Pharmaceutical Co., Ltd 5ea93b2b-115b-4591-97ea-311d77e3a5ba 2024-01-09 Warnings, Adverse reactions Name fallback brand name: Esomeprazole magnesium generic name: ESOMEPRAZOLE MAGNESIUM Esomeprazole magnesium ESOMEPRAZOLE MAGNESIUM Solco Healthcare US LLC 3cd80c04-43a2-4be3-b831-ebccc273a0d2 2023-12-28 Warnings, Adverse reactions Name fallback brand name: Esomeprazole magnesium generic name: ESOMEPRAZOLE MAGNESIUM Esomeprazole Magnesium ESOMEPRAZOLE MAGNESIUM A-S Medication Solutions 71956762-d2f7-4763-9afe-1ca8f32a3cbb 2023-12-27 Warnings, Adverse reactions Name fallback brand name: Esomeprazole Magnesium generic name: ESOMEPRAZOLE MAGNESIUM Esomeprazole Magnesium ESOMEPRAZOLE MAGNESIUM A-S Medication Solutions 99fceec8-59a2-485f-a7f3-7c5afd98401d 2023-12-27 Warnings, Adverse reactions Name fallback brand name: Esomeprazole Magnesium generic name: ESOMEPRAZOLE MAGNESIUM Esomeprazole Magnesium ESOMEPRAZOLE MAGNESIUM Dr. Reddys Laboratories Inc 2c2bcdf7-689a-47bd-1713-0ea74f72044b 2023-12-14 Warnings Name fallback brand name: Esomeprazole Magnesium generic name: ESOMEPRAZOLE MAGNESIUM Esomeprazole Magnesium ESOMEPRAZOLE MAGNESIUM Glenmark Pharmaceuticals Inc., USA a6430045-ae60-4a16-92b9-2975cb497629 2023-12-07 Warnings, Adverse reactions Name fallback brand name: Esomeprazole Magnesium generic name: ESOMEPRAZOLE MAGNESIUM Esomeprazole magnesium ESOMEPRAZOLE MAGNESIUM TIME CAP LABORATORIES, INC. 08acf79f-f50d-8416-e063-6294a90a2704 2023-11-23 Warnings Name fallback brand name: Esomeprazole magnesium generic name: ESOMEPRAZOLE MAGNESIUM Esomeprazole magnesium ESOMEPRAZOLE MAGNESIUM BETTER LIVING BRANDS, LLC eb4c1cac-89a2-c040-e053-2995a90ae1cd 2023-11-17 Warnings Name fallback brand name: Esomeprazole magnesium generic name: ESOMEPRAZOLE MAGNESIUM Esomeprazole Magnesium ESOMEPRAZOLE MAGNESIUM Mylan Pharmaceuticals Inc. e04e7c84-59c8-4a1d-8dfc-d72588b97b59 2023-11-15 Warnings, Adverse reactions Name fallback brand name: Esomeprazole Magnesium generic name: ESOMEPRAZOLE MAGNESIUM Esomeprazole ESOMEPRAZOLE MAGNESIUM VALU MERCHANDISERS COMPANY ab83bbdd-2c8e-46bd-b39e-69199e004be4 2023-11-03 Warnings Name fallback generic name: ESOMEPRAZOLE MAGNESIUM Esomeprazole Magnesium ESOMEPRAZOLE MAGNESIUM A-S Medication Solutions def3f166-e740-41ed-82c0-9b03dd6432b1 2023-11-02 Warnings, Adverse reactions Name fallback brand name: Esomeprazole Magnesium generic name: ESOMEPRAZOLE MAGNESIUM Esomeprazole Magnesium ESOMEPRAZOLE MAGNESIUM A-S Medication Solutions e79725fe-54c8-4dcb-a03a-0c91cc20cf77 2023-10-31 Warnings, Adverse reactions 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.