Home Applications 203349 Application 203349
Type ANDA
Sponsor GLAND PHARMA LTD Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ESOMEPRAZOLE SODIUM ESOMEPRAZOLE SODIUM INJECTABLE;INTRAVENOUS EQ 20MG BASE/VIAL No No 002 ESOMEPRAZOLE SODIUM ESOMEPRAZOLE SODIUM INJECTABLE;INTRAVENOUS EQ 40MG BASE/VIAL No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A203349-001 ESOMEPRAZOLE SODIUM ESOMEPRAZOLE SODIUM EQ 20MG BASE/VIAL INJECTABLE / INTRAVENOUS RS 2020-04-01 A203349-002 ESOMEPRAZOLE SODIUM ESOMEPRAZOLE SODIUM EQ 40MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2020-04-01
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A203349-002 AP
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.
Product history page 1 of 2 · 74 observed 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 2026-02-19 14:30 UTC 2026-02 A203349-001 ESOMEPRAZOLE SODIUM EQ 20MG BASE/VIAL INJECTABLE / INTRAVENOUS RS 2020-04-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203349-002 ESOMEPRAZOLE SODIUM EQ 40MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2020-04-01 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203349-001 ESOMEPRAZOLE SODIUM EQ 20MG BASE/VIAL INJECTABLE / INTRAVENOUS RS 2020-04-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203349-002 ESOMEPRAZOLE SODIUM EQ 40MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2020-04-01 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A203349-001 ESOMEPRAZOLE SODIUM EQ 20MG BASE/VIAL INJECTABLE / INTRAVENOUS RS 2020-04-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203349-002 ESOMEPRAZOLE SODIUM EQ 40MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2020-04-01 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203349-001 ESOMEPRAZOLE SODIUM EQ 20MG BASE/VIAL INJECTABLE / INTRAVENOUS RS 2020-04-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203349-002 ESOMEPRAZOLE SODIUM EQ 40MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2020-04-01 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203349-001 ESOMEPRAZOLE SODIUM EQ 20MG BASE/VIAL INJECTABLE / INTRAVENOUS RS 2020-04-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203349-002 ESOMEPRAZOLE SODIUM EQ 40MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2020-04-01 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203349-001 ESOMEPRAZOLE SODIUM EQ 20MG BASE/VIAL INJECTABLE / INTRAVENOUS RS 2020-04-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203349-002 ESOMEPRAZOLE SODIUM EQ 40MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2020-04-01 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203349-001 ESOMEPRAZOLE SODIUM EQ 20MG BASE/VIAL INJECTABLE / INTRAVENOUS RS 2020-04-01 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203349-002 ESOMEPRAZOLE SODIUM EQ 40MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2020-04-01 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203349-001 ESOMEPRAZOLE SODIUM EQ 20MG BASE/VIAL INJECTABLE / INTRAVENOUS RS 2020-04-01 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203349-002 ESOMEPRAZOLE SODIUM EQ 40MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2020-04-01 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203349-001 ESOMEPRAZOLE SODIUM EQ 20MG BASE/VIAL INJECTABLE / INTRAVENOUS RS 2020-04-01 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203349-002 ESOMEPRAZOLE SODIUM EQ 40MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2020-04-01 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A203349-001 ESOMEPRAZOLE SODIUM EQ 20MG BASE/VIAL INJECTABLE / INTRAVENOUS RS 2020-04-01 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A203349-002 ESOMEPRAZOLE SODIUM EQ 40MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2020-04-01 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203349-001 ESOMEPRAZOLE SODIUM EQ 20MG BASE/VIAL INJECTABLE / INTRAVENOUS RS 2020-04-01 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203349-002 ESOMEPRAZOLE SODIUM EQ 40MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2020-04-01 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203349-001 ESOMEPRAZOLE SODIUM EQ 20MG BASE/VIAL INJECTABLE / INTRAVENOUS RS 2020-04-01 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203349-002 ESOMEPRAZOLE SODIUM EQ 40MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2020-04-01 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203349-001 ESOMEPRAZOLE SODIUM EQ 20MG BASE/VIAL INJECTABLE / INTRAVENOUS RS 2020-04-01 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203349-002 ESOMEPRAZOLE SODIUM EQ 40MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2020-04-01 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A203349-001 ESOMEPRAZOLE SODIUM EQ 20MG BASE/VIAL INJECTABLE / INTRAVENOUS 2020-04-01 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A203349-002 ESOMEPRAZOLE SODIUM EQ 40MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2020-04-01 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A203349-001 ESOMEPRAZOLE SODIUM EQ 20MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2020-04-01 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A203349-002 ESOMEPRAZOLE SODIUM EQ 40MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2020-04-01 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A203349-001 ESOMEPRAZOLE SODIUM EQ 20MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2020-04-01 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A203349-002 ESOMEPRAZOLE SODIUM EQ 40MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2020-04-01 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A203349-001 ESOMEPRAZOLE SODIUM EQ 20MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2020-04-01 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A203349-002 ESOMEPRAZOLE SODIUM EQ 40MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2020-04-01 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A203349-001 ESOMEPRAZOLE SODIUM EQ 20MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2020-04-01 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A203349-002 ESOMEPRAZOLE SODIUM EQ 40MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2020-04-01 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A203349-001 ESOMEPRAZOLE SODIUM EQ 20MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2020-04-01 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A203349-002 ESOMEPRAZOLE SODIUM EQ 40MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2020-04-01 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A203349-001 ESOMEPRAZOLE SODIUM EQ 20MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2020-04-01 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A203349-002 ESOMEPRAZOLE SODIUM EQ 40MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2020-04-01 87673890dc5c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 52 observed states.
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 1 of 1 · 1 matching rows.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 6 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 68083-451 Esomeprazole Sodium Esomeprazole Sodium Gland Pharma Limited ANDA Current 68083-451 Esomeprazole Sodium Esomeprazole Sodium Gland Pharma Limited ANDA Current 68083-451 Esomeprazole Sodium Esomeprazole Sodium Gland Pharma Limited ANDA Current 68083-452 Esomeprazole Sodium Esomeprazole Sodium Gland Pharma Limited ANDA Current 68083-452 Esomeprazole Sodium Esomeprazole Sodium Gland Pharma Limited ANDA Current 68083-452 Esomeprazole Sodium Esomeprazole Sodium Gland Pharma Limited ANDA Current