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 4 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 CVS Pharmacy 0b3b2f9b-f7f3-1a32-4e14-f10aecd6aabb 2025-08-30 Warnings Name fallback brand name: Esomeprazole Magnesium generic name: ESOMEPRAZOLE MAGNESIUM Esomeprazole Magnesium ESOMEPRAZOLE MAGNESIUM Amerisource Bergen 3c6c2fd5-1a0f-44f7-8d02-c9bc26b8db46 2025-08-30 Warnings Name fallback brand name: Esomeprazole Magnesium generic name: ESOMEPRAZOLE MAGNESIUM Esomeprazole Magnesium ESOMEPRAZOLE MAGNESIUM PD-Rx Pharmaceuticals, Inc. ac12cd05-10cf-4694-a9e8-e5f04fe162a7 2025-06-20 Warnings, Adverse reactions Name fallback brand name: Esomeprazole Magnesium generic name: ESOMEPRAZOLE MAGNESIUM Esomeprazole magnesium ESOMEPRAZOLE MAGNESIUM DELAYED RELEASE CAPSULES Ascend Laboratories, LLC 277ce748-2809-4be0-81e7-6a4d604f2c6f 2025-06-11 Warnings, Adverse reactions Name fallback brand name: Esomeprazole magnesium Up and Up Esomeprazole Magnesium ESOMEPRAZOLE MAGNESIUM Target Corporation b3d3ad1d-96f8-4f72-ae66-f14940a62882 2025-06-02 Warnings Name fallback generic name: ESOMEPRAZOLE MAGNESIUM Esomeprazole Magnesium ESOMEPRAZOLE MAGNESIUM Aurohealth LLC b594f052-b6be-4d3b-9316-29cab050344a 2025-05-20 Warnings Name fallback brand name: Esomeprazole Magnesium generic name: ESOMEPRAZOLE MAGNESIUM Esomeprazole Magnesium ESOMEPRAZOLE MAGNESIUM NuCare Pharmaceuticals,Inc. 2879c79f-bf2a-0bc9-e063-6394a90a98ae 2025-04-28 Warnings, Adverse reactions Name fallback brand name: Esomeprazole Magnesium generic name: ESOMEPRAZOLE MAGNESIUM ESOMEPRAZOLE MAGNESIUM ESOMEPRAZOLE MAGNESIUM LEADER/ CARDINAL HEALTH 110, INC. c98b4332-ce47-422e-be54-f3eee0762354 2025-04-24 Warnings Name fallback brand name: ESOMEPRAZOLE MAGNESIUM generic name: ESOMEPRAZOLE MAGNESIUM Esomeprazole Magnesium Delayed Release ESOMEPRAZOLE MAGNESIUM WALGREENS 2fa5d747-a014-2475-e063-6294a90ab918 2025-04-21 Warnings Name fallback generic name: ESOMEPRAZOLE MAGNESIUM Esomeprazole Magnesium ESOMEPRAZOLE MAGNESIUM Aurobindo Pharma Limited 3c7a6b13-c67d-48f7-b170-1437a420d704 2025-04-16 Warnings, Adverse reactions Name fallback brand name: Esomeprazole Magnesium generic name: ESOMEPRAZOLE MAGNESIUM Esomeprazole Magnesium ESOMEPRAZOLE MAGNESIUM Aurobindo Pharma Limited e691b51e-2e31-4408-81c4-5afec6f9bbb6 2025-04-16 Warnings, Adverse reactions Name fallback brand name: Esomeprazole Magnesium generic name: ESOMEPRAZOLE MAGNESIUM esomeprazole magnesium ESOMEPRAZOLE MAGNESIUM Preferred Pharmaceuticals Inc. 2d21ed0b-a089-46f4-9ebb-f24f9f3af61d 2025-04-16 Warnings, Adverse reactions Name fallback brand name: esomeprazole magnesium generic name: ESOMEPRAZOLE MAGNESIUM Esomeprazole Magnesium ESOMEPRAZOLE MAGNESIUM Aurobindo Pharma Limited 7038a0bc-99b2-4a6e-9b9a-0646ec187706 2025-04-08 Warnings, Adverse reactions Name fallback brand name: Esomeprazole Magnesium generic name: ESOMEPRAZOLE MAGNESIUM Esomeprazole Magnesium ESOMEPRAZOLE MAGNESIUM Camber Consumer Care Inc d2554c3d-eb0b-4bf8-aebc-18be7b195c8e 2025-04-05 Warnings Name fallback brand name: Esomeprazole Magnesium generic name: ESOMEPRAZOLE MAGNESIUM Esomeprazole Magnesium ESOMEPRAZOLE MAGNESIUM Aurobindo Pharma Limited f4ae091d-9b74-4a0e-ac68-057effd91e17 2025-03-26 Warnings, Adverse reactions Name fallback brand name: Esomeprazole Magnesium generic name: ESOMEPRAZOLE MAGNESIUM Esomeprazole Magnesium ESOMEPRAZOLE MAGNESIUM Aurohealth LLC 5647bfb0-6af0-4580-b202-0f1fc9c41265 2025-03-13 Warnings Name fallback brand name: Esomeprazole Magnesium generic name: ESOMEPRAZOLE MAGNESIUM ESOMEPRAZOLE MAGNESIUM ESOMEPRAZOLE MAGNESIUM Quallent Pharmaceuticals Health LLC 7362f930-0879-451e-8de9-8bb8565bfb7e 2025-02-28 Warnings, Adverse reactions Name fallback brand name: ESOMEPRAZOLE MAGNESIUM generic name: ESOMEPRAZOLE MAGNESIUM esomeprazole magnesium ESOMEPRAZOLE MAGNESIUM Biocon Pharma Inc., 66c9e2bf-2dc4-4683-89fd-6dadf1b01ee9 2025-02-28 Warnings, Adverse reactions Name fallback brand name: esomeprazole magnesium generic name: ESOMEPRAZOLE MAGNESIUM Esomeprazole Magnesium ESOMEPRAZOLE MAGNESIUM Publix c45fd180-9d81-41e0-b7f8-025b8f29763a 2025-02-21 Warnings Name fallback brand name: Esomeprazole Magnesium generic name: ESOMEPRAZOLE MAGNESIUM esomeprazole magnesium ESOMEPRAZOLE MAGNESIUM NuCare Pharmaceuticals,Inc. fe7d7aa8-4f46-83ae-e053-6394a90a01d6 2025-02-04 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.