Application 202686

Type: ANDA
Sponsor: MYLAN LABS 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
A202686-001	ESOMEPRAZOLE SODIUM	ESOMEPRAZOLE SODIUM	EQ 20MG BASE/VIAL	INJECTABLE / INTRAVENOUS			2017-05-17
A202686-002	ESOMEPRAZOLE SODIUM	ESOMEPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS			2017-05-17

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 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A202686-001	ESOMEPRAZOLE SODIUM	EQ 20MG BASE/VIAL	INJECTABLE / INTRAVENOUS		2017-05-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202686-002	ESOMEPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS		2017-05-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202686-001	ESOMEPRAZOLE SODIUM	EQ 20MG BASE/VIAL	INJECTABLE / INTRAVENOUS		2017-05-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202686-002	ESOMEPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS		2017-05-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202686-001	ESOMEPRAZOLE SODIUM	EQ 20MG BASE/VIAL	INJECTABLE / INTRAVENOUS		2017-05-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202686-002	ESOMEPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS		2017-05-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202686-001	ESOMEPRAZOLE SODIUM	EQ 20MG BASE/VIAL	INJECTABLE / INTRAVENOUS		2017-05-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202686-002	ESOMEPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS		2017-05-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202686-001	ESOMEPRAZOLE SODIUM	EQ 20MG BASE/VIAL	INJECTABLE / INTRAVENOUS		2017-05-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202686-002	ESOMEPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS		2017-05-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202686-001	ESOMEPRAZOLE SODIUM	EQ 20MG BASE/VIAL	INJECTABLE / INTRAVENOUS		2017-05-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202686-002	ESOMEPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS		2017-05-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202686-001	ESOMEPRAZOLE SODIUM	EQ 20MG BASE/VIAL	INJECTABLE / INTRAVENOUS		2017-05-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202686-002	ESOMEPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS		2017-05-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202686-001	ESOMEPRAZOLE SODIUM	EQ 20MG BASE/VIAL	INJECTABLE / INTRAVENOUS		2017-05-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202686-002	ESOMEPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS		2017-05-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202686-001	ESOMEPRAZOLE SODIUM	EQ 20MG BASE/VIAL	INJECTABLE / INTRAVENOUS		2017-05-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202686-002	ESOMEPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS		2017-05-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202686-001	ESOMEPRAZOLE SODIUM	EQ 20MG BASE/VIAL	INJECTABLE / INTRAVENOUS		2017-05-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202686-002	ESOMEPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS		2017-05-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202686-001	ESOMEPRAZOLE SODIUM	EQ 20MG BASE/VIAL	INJECTABLE / INTRAVENOUS		2017-05-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202686-002	ESOMEPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS		2017-05-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202686-001	ESOMEPRAZOLE SODIUM	EQ 20MG BASE/VIAL	INJECTABLE / INTRAVENOUS		2017-05-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202686-002	ESOMEPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS		2017-05-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202686-001	ESOMEPRAZOLE SODIUM	EQ 20MG BASE/VIAL	INJECTABLE / INTRAVENOUS		2017-05-17	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202686-002	ESOMEPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS		2017-05-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202686-001	ESOMEPRAZOLE SODIUM	EQ 20MG BASE/VIAL	INJECTABLE / INTRAVENOUS		2017-05-17	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A202686-002	ESOMEPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS		2017-05-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202686-001	ESOMEPRAZOLE SODIUM	EQ 20MG BASE/VIAL	INJECTABLE / INTRAVENOUS		2017-05-17	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202686-002	ESOMEPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS		2017-05-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202686-001	ESOMEPRAZOLE SODIUM	EQ 20MG BASE/VIAL	INJECTABLE / INTRAVENOUS		2017-05-17	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A202686-002	ESOMEPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2017-05-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202686-001	ESOMEPRAZOLE SODIUM	EQ 20MG BASE/VIAL	INJECTABLE / INTRAVENOUS		2017-05-17	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A202686-002	ESOMEPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2017-05-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202686-001	ESOMEPRAZOLE SODIUM	EQ 20MG BASE/VIAL	INJECTABLE / INTRAVENOUS		2017-05-17	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A202686-002	ESOMEPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2017-05-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202686-001	ESOMEPRAZOLE SODIUM	EQ 20MG BASE/VIAL	INJECTABLE / INTRAVENOUS		2017-05-17	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A202686-002	ESOMEPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2017-05-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202686-001	ESOMEPRAZOLE SODIUM	EQ 20MG BASE/VIAL	INJECTABLE / INTRAVENOUS		2017-05-17	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A202686-002	ESOMEPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2017-05-17	`782e0a99824c…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-04-08 23:34 UTC	2022-04	A202686-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202686-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202686-002	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202686-002	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202686-002	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202686-002	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202686-002	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202686-002	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202686-002	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202686-002	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202686-002	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202686-002	AP	1	`ea99ee380514…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Esomeprazole sodium	ESOMEPRAZOLE SODIUM	Slate Run Pharmaceuticals, LLC	23395673-116d-4a8e-b0ce-59f9ca5b3daf	2026-06-22	Warnings, Adverse reactions	Name fallback brand name: Esomeprazole sodium generic name: ESOMEPRAZOLE SODIUM
Esomeprazole Sodium	ESOMEPRAZOLE SODIUM	Eugia US LLC	45a15ba2-2aae-4edc-beaa-4a2357d87f32	2025-11-07	Warnings, Adverse reactions	Name fallback brand name: Esomeprazole Sodium generic name: ESOMEPRAZOLE SODIUM
Esomeprazole Sodium	ESOMEPRAZOLE SODIUM	Gland Pharma Limited	9354958c-e997-41c8-8605-23f0a58993c0	2023-07-21	Warnings, Adverse reactions	Name fallback brand name: Esomeprazole Sodium generic name: ESOMEPRAZOLE SODIUM

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
67457-392	Esomeprazole sodium	Esomeprazole sodium	Mylan Institutional LLC	ANDA	Current
67457-392	Esomeprazole sodium	Esomeprazole sodium	Mylan Institutional LLC	ANDA	Current
67457-392	Esomeprazole sodium	Esomeprazole sodium	Mylan Institutional LLC	ANDA	Current
67457-392	Esomeprazole sodium	Esomeprazole sodium	Mylan Institutional LLC	ANDA	Current
67457-392	Esomeprazole sodium	Esomeprazole sodium	Mylan Institutional LLC	ANDA	Current
67457-392	Esomeprazole sodium	Esomeprazole sodium	Mylan Institutional LLC	ANDA	Current