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 6 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 A-S Medication Solutions 42b8d3f5-d919-48dd-92e4-ed49488dd664 2024-10-21 Warnings, Adverse reactions Name fallback brand name: Esomeprazole Magnesium generic name: ESOMEPRAZOLE MAGNESIUM Esomeprazole magnesium ESOMEPRAZOLE MAGNESIUM DELAYED RELEASE CAPSULES Asclemed USA, Inc. 85a963c1-9c13-4eb7-826b-08d5a991fe28 2024-10-04 Warnings, Adverse reactions Name fallback brand name: Esomeprazole magnesium Esomeprazole magnesium ESOMEPRAZOLE MAGNESIUM DELAYED RELEASE CAPSULES Proficient Rx LP ad05cdde-a9e9-4442-80c4-1b02f5ebf6b4 2024-10-01 Warnings, Adverse reactions Name fallback brand name: Esomeprazole magnesium esomeprazole magnesium ESOMEPRAZOLE MAGNESIUM Bryant Ranch Prepack f99f95a2-60e4-4781-80a9-e5b12897dff1 2024-09-03 Warnings, Adverse reactions Name fallback brand name: esomeprazole magnesium generic name: ESOMEPRAZOLE MAGNESIUM topcare esomeprazole magnesium ESOMEPRAZOLE MAGNESIUM Topco Associates LLC 86384845-0bea-490b-b04a-5770ef88b639 2024-09-01 Warnings Name fallback generic name: ESOMEPRAZOLE MAGNESIUM Esomeprazole Magnesium ESOMEPRAZOLE MAGNESIUM Bryant Ranch Prepack 7778bf7c-52f7-44b3-ac2c-e5a25f6967b7 2024-08-23 Warnings, Adverse reactions Name fallback brand name: Esomeprazole Magnesium generic name: ESOMEPRAZOLE MAGNESIUM Esomeprazole magnesium ESOMEPRAZOLE MAGNESIUM DELAYED RELEASE CAPSULES Bryant Ranch Prepack db8a346e-dba1-41bc-b122-a1de868ee91a 2024-08-23 Warnings, Adverse reactions Name fallback brand name: Esomeprazole magnesium Esomeprazole magnesium ESOMEPRAZOLE MAGNESIUM Bryant Ranch Prepack 192c63f0-25ac-410e-ae75-62e96cbf6f9d 2024-08-15 Warnings, Adverse reactions Name fallback brand name: Esomeprazole magnesium generic name: ESOMEPRAZOLE MAGNESIUM Esomeprazole Magnesium ESOMEPRAZOLE MAGNESIUM Bryant Ranch Prepack 61cc0020-aab8-42a3-b0a6-93062f382c87 2024-08-12 Warnings, Adverse reactions Name fallback brand name: Esomeprazole Magnesium generic name: ESOMEPRAZOLE MAGNESIUM esomeprazole magnesium ESOMEPRAZOLE MAGNESIUM Bryant Ranch Prepack 2f1b1a56-b6c4-4e30-a1f7-12701aa5a535 2024-08-08 Warnings, Adverse reactions Name fallback brand name: esomeprazole magnesium generic name: ESOMEPRAZOLE MAGNESIUM esomeprazole magnesium ESOMEPRAZOLE MAGNESIUM CVS Pharmacy dcaaf24a-0fb9-41b9-881a-00fa60796ca9 2024-08-06 Warnings Name fallback brand name: esomeprazole magnesium generic name: ESOMEPRAZOLE MAGNESIUM esomeprazole magnesium ESOMEPRAZOLE MAGNESIUM Meijer Distribution Inc 1dd30fec-15f4-44b2-a38f-e59ff4da206d 2024-08-06 Warnings Name fallback brand name: esomeprazole magnesium generic name: ESOMEPRAZOLE MAGNESIUM Esomeprazole Magnesium ESOMEPRAZOLE MAGNESIUM Advanced Rx of Tennessee, LLC 1e92676a-6c59-796d-e063-6294a90aaab4 2024-07-31 Warnings, Adverse reactions Name fallback brand name: Esomeprazole Magnesium generic name: ESOMEPRAZOLE MAGNESIUM Esomeprazole Magnesium ESOMEPRAZOLE H E B 0d08dd06-8df6-43ff-9033-8eebd215bec1 2024-07-26 Warnings Name fallback brand name: Esomeprazole Magnesium esomeprazole magnesium ESOMEPRAZOLE Kroger Company da02c079-ed18-4896-896d-0489c8f43554 2024-07-25 Warnings Name fallback brand name: esomeprazole magnesium esomeprazole magnesium ESOMEPRAZOLE Meijer Distribution Inc 126c269b-260d-40f4-879d-169c09251c67 2024-07-25 Warnings Name fallback brand name: esomeprazole magnesium Esomeprazole Magnesium ESOMEPRAZOLE MAGNESIUM Advanced Rx of Tennessee, LLC 1d8bd104-66d4-8c19-e063-6394a90a3cb6 2024-07-18 Warnings, Adverse reactions Name fallback brand name: Esomeprazole Magnesium generic name: ESOMEPRAZOLE MAGNESIUM Esomeprazole Magnesium ESOMEPRAZOLE MAGNESIUM Camber Pharmaceuticals, Inc. c18067ba-26ba-40b4-a328-3011710be216 2024-07-12 Warnings, Adverse reactions Name fallback brand name: Esomeprazole Magnesium generic name: ESOMEPRAZOLE MAGNESIUM Esomeprazole Magnesium ESOMEPRAZOLE MAGNESIUM CVS Pharmacy, Inc. 1867185e-9c34-c8cc-e063-6394a90ab3b1 2024-07-09 Warnings Name fallback brand name: Esomeprazole Magnesium generic name: ESOMEPRAZOLE MAGNESIUM Esomeprazole Magnesium ESOMEPRAZOLE MAGNESIUM Bryant Ranch Prepack 009794ae-8199-4176-9dc6-4c5e752d845c 2024-07-09 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.