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 2 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 NCS HealthCare of KY, LLC dba Vangard Labs 28fbfa02-6c7b-4eb1-af24-86825e652326 2026-04-14 Warnings, Adverse reactions Name fallback brand name: Esomeprazole Magnesium generic name: ESOMEPRAZOLE MAGNESIUM Esomeprazole Magnesium ESOMEPRAZOLE MAGNESIUM Preferred Pharmaceuticals Inc. a9d05a38-08db-4710-b6f3-20c92ce885d5 2026-04-13 Warnings, Adverse reactions Name fallback brand name: Esomeprazole Magnesium generic name: ESOMEPRAZOLE MAGNESIUM Esomeprazole Magnesium ESOMEPRAZOLE MAGNESIUM A-S Medication Solutions b58bfbdb-939e-456e-827d-068e9d808840 2026-04-13 Warnings, Adverse reactions Name fallback brand name: Esomeprazole Magnesium generic name: ESOMEPRAZOLE MAGNESIUM Esomeprazole Magnesium ESOMEPRAZOLE MAGNESIUM A-S Medication Solutions 8a8ca4cf-076c-48c9-8613-f5a1bae87a49 2026-04-13 Warnings, Adverse reactions Name fallback brand name: Esomeprazole Magnesium generic name: ESOMEPRAZOLE MAGNESIUM Esomeprazole Magnesium ESOMEPRAZOLE MAGNESIUM AvPAK 4db9f4b8-b6df-f6e9-e063-6294a90a9f60 2026-03-31 Warnings, Adverse reactions Name fallback brand name: Esomeprazole Magnesium generic name: ESOMEPRAZOLE MAGNESIUM Acid Reducer ESOMEPRAZOLE MAGNESIUM Walgreens 4f3c1d76-e1ba-4f85-9384-ed8f35fa6bc6 2026-03-25 Warnings Name fallback generic name: ESOMEPRAZOLE MAGNESIUM esomeprazole magnesium ESOMEPRAZOLE MAGNESIUM DIHYDRATE HyVee Inc c2308fc8-1549-476d-9769-2991051360ad 2026-03-24 Warnings Name fallback brand name: esomeprazole magnesium Esomeprazole Magnesium ESOMEPRAZOLE MAGNESIUM REMEDYREPACK INC. ab3d31c8-cab1-4c44-bacd-5e5c67dd1384 2026-03-06 Warnings, Adverse reactions Name fallback brand name: Esomeprazole Magnesium generic name: ESOMEPRAZOLE MAGNESIUM Esomeprazole Magnesium ESOMEPRAZOLE MAGNESIUM DIHYDRATE Walgreen Company 29eb7b87-59a4-4d27-ad53-789da7fec427 2026-02-28 Warnings Name fallback brand name: Esomeprazole Magnesium Esomeprazole Magnesium ESOMEPRAZOLE MAGNESIUM Aurohealth LLC 034bcbad-f57f-4338-a193-7a5aa9f09aa6 2026-02-12 Warnings Name fallback brand name: Esomeprazole Magnesium generic name: ESOMEPRAZOLE MAGNESIUM Esomeprazole Magnesium ESOMEPRAZOLE MAGNESIUM A-S Medication Solutions 27e7f7f0-7403-4425-8baa-d12ae9321364 2026-02-11 Warnings, Adverse reactions Name fallback brand name: Esomeprazole Magnesium generic name: ESOMEPRAZOLE MAGNESIUM Esomeprazole Magnesium ESOMEPRAZOLE MAGNESIUM YYBA CORP 4a7f3a55-862f-111f-e063-6294a90a6a44 2026-02-10 Warnings Name fallback brand name: Esomeprazole Magnesium generic name: ESOMEPRAZOLE MAGNESIUM esomeprazole magnesium ESOMEPRAZOLE HyVee Inc b0968243-171e-428a-b692-740e0c05a0fc 2026-01-29 Warnings Name fallback brand name: esomeprazole magnesium esomeprazole magnesium ESOMEPRAZOLE MAGNESIUM GLENMARK THERAPEUTICS INC., USA da5ec2c4-833e-4d2a-a61f-b43835c7f473 2026-01-23 Warnings Name fallback brand name: esomeprazole magnesium generic name: ESOMEPRAZOLE MAGNESIUM Acid Reducer ESOMEPRAZOLE MAGNESIUM CVS Pharmacy 001817ea-906e-47f7-8605-41ba5a9abd21 2026-01-21 Warnings Name fallback generic name: ESOMEPRAZOLE MAGNESIUM Esomeprazole Magnesium ESOMEPRAZOLE MAGNESIUM A-S Medication Solutions 00aa81c2-73c7-4bf8-94e9-f644381b631f 2026-01-20 Warnings, Adverse reactions Name fallback brand name: Esomeprazole Magnesium generic name: ESOMEPRAZOLE MAGNESIUM NEXIUM ESOMEPRAZOLE MAGNESIUM AstraZeneca Pharmaceuticals LP f4853677-1622-4037-688b-fdf533a11d96 2025-12-19 Warnings, Adverse reactions Name fallback generic name: ESOMEPRAZOLE MAGNESIUM Esomeprazole Magnesium ESOMEPRAZOLE MAGNESIUM NuCare Pharmaceuticals, Inc. 463c9b3b-dd6b-7ee7-e063-6394a90afb43 2025-12-18 Warnings, Adverse reactions Name fallback brand name: Esomeprazole Magnesium generic name: ESOMEPRAZOLE MAGNESIUM Esomeprazole Magnesium ESOMEPRAZOLE MAGNESIUM Lannett Company, Inc. eb8f8b81-d482-4b94-be87-c766f49e753f 2025-11-20 Warnings, Adverse reactions Name fallback brand name: Esomeprazole Magnesium generic name: ESOMEPRAZOLE MAGNESIUM Esomeprazole ESOMEPRAZOLE MAGNESIUM YYBA CORP 0912d311-e26c-479d-9f13-ef0ac403e9b8 2025-11-19 Warnings Name fallback generic name: ESOMEPRAZOLE MAGNESIUM
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.