Application 209647

Type: ANDA
Sponsor: AMNEAL PHARMS NY

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM	CAPSULE, DELAYED REL PELLETS;ORAL	EQ 20MG BASE	No	No
002	ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM	CAPSULE, DELAYED REL PELLETS;ORAL	EQ 40MG 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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A209647-001	ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL			2019-04-10
A209647-002	ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL			2019-04-10

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 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A209647-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	2019-04-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209647-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	2019-04-10	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A209647-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	2019-04-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209647-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	2019-04-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209647-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	2019-04-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209647-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	2019-04-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209647-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	2019-04-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209647-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	2019-04-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209647-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	2019-04-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209647-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	2019-04-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209647-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	2019-04-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209647-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	2019-04-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209647-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	2019-04-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209647-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	2019-04-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209647-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	2019-04-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209647-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	2019-04-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209647-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	2019-04-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209647-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	2019-04-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209647-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	2019-04-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209647-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	2019-04-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209647-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	2019-04-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209647-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	2019-04-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209647-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	2019-04-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209647-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	2019-04-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209647-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	2019-04-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209647-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	2019-04-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209647-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	2019-04-10	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209647-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	2019-04-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209647-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	2019-04-10	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209647-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	2019-04-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209647-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	2019-04-10	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A209647-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	2019-04-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209647-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	2019-04-10	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209647-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	2019-04-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209647-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	2019-04-10	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A209647-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	2019-04-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209647-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	2019-04-10	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A209647-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	2019-04-10	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209647-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	2019-04-10	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A209647-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	2019-04-10	`74a2ff9319b5…`

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 9 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	Zydus Pharmaceuticals USA Inc.	190a4c5b-1547-45d7-b00b-10da4131e2e2	2023-08-17	Warnings, Adverse reactions	Name fallback brand name: Esomeprazole Magnesium generic name: ESOMEPRAZOLE MAGNESIUM
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	Dr. Reddy's Laboratories Inc	15023261-51c8-2388-3439-48dace49ec02	2023-07-25	Warnings, Adverse reactions	Name fallback brand name: Esomeprazole Magnesium generic name: ESOMEPRAZOLE MAGNESIUM
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	NorthStar Rx LLC	380da8db-bfa3-8c0c-f8f3-573675fed981	2023-07-15	Warnings, Adverse reactions	Name fallback brand name: Esomeprazole Magnesium generic name: ESOMEPRAZOLE MAGNESIUM
esomeprazole magnesium	ESOMEPRAZOLE MAGNESIUM	GLENMARK THERAPEUTICS INC., USA	ff233fbb-716d-4879-811c-c8d82e3c99ce	2023-05-25		Name fallback brand name: esomeprazole magnesium generic name: ESOMEPRAZOLE MAGNESIUM
ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM	Reliable 1 Laboratories LLC	15d2c4f7-5b20-4c7c-b2a6-9baed7bf39cf	2023-04-15		Name fallback brand name: ESOMEPRAZOLE MAGNESIUM generic name: ESOMEPRAZOLE MAGNESIUM
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	Proficient Rx LP	e5540d90-0b6e-4519-9272-c6e96730967b	2023-02-01	Warnings, Adverse reactions	Name fallback brand name: Esomeprazole Magnesium generic name: ESOMEPRAZOLE MAGNESIUM
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	Dr. Reddy's Laboratories Inc	cb8297ad-ce1b-aa31-2488-5a38b2dbc774	2022-09-30	Warnings	Name fallback brand name: Esomeprazole Magnesium generic name: ESOMEPRAZOLE MAGNESIUM
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	Proficient Rx LP	9224142a-6e14-4ca3-9e72-506ff9fbd0e1	2022-07-01	Warnings, Adverse reactions	Name fallback brand name: Esomeprazole Magnesium generic name: ESOMEPRAZOLE MAGNESIUM
Esomeprazole	ESOMEPRAZOLE MAGNESIUM	HARRIS TEETER	ea9ef7b0-7397-470f-b852-397e8b0e66e4	2021-04-30	Warnings	Name fallback generic name: ESOMEPRAZOLE MAGNESIUM
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	Retail Business Services, LLC.	ce376d91-0ea8-4922-9f7f-707420cb1d96	2021-03-12	Warnings	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.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 14 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
65162-644	Esomeprazole Magnesium	Esomeprazole Magnesium	Amneal Pharmaceuticals LLC	ANDA	Current
65162-644	Esomeprazole Magnesium	Esomeprazole Magnesium	Amneal Pharmaceuticals LLC	ANDA	Current
65162-644	Esomeprazole Magnesium	Esomeprazole Magnesium	Amneal Pharmaceuticals LLC	ANDA	Current
65162-644	Esomeprazole Magnesium	Esomeprazole Magnesium	Amneal Pharmaceuticals LLC	ANDA	Current
65162-644	Esomeprazole Magnesium	Esomeprazole Magnesium	Amneal Pharmaceuticals LLC	ANDA	Current
65162-644	Esomeprazole Magnesium	Esomeprazole Magnesium	Amneal Pharmaceuticals LLC	ANDA	Current
65162-644	Esomeprazole Magnesium	Esomeprazole Magnesium	Amneal Pharmaceuticals LLC	ANDA	Current
65162-645	Esomeprazole Magnesium	Esomeprazole Magnesium	Amneal Pharmaceuticals LLC	ANDA	Current
65162-645	Esomeprazole Magnesium	Esomeprazole Magnesium	Amneal Pharmaceuticals LLC	ANDA	Current
65162-645	Esomeprazole Magnesium	Esomeprazole Magnesium	Amneal Pharmaceuticals LLC	ANDA	Current
65162-645	Esomeprazole Magnesium	Esomeprazole Magnesium	Amneal Pharmaceuticals LLC	ANDA	Current
65162-645	Esomeprazole Magnesium	Esomeprazole Magnesium	Amneal Pharmaceuticals LLC	ANDA	Current
65162-645	Esomeprazole Magnesium	Esomeprazole Magnesium	Amneal Pharmaceuticals LLC	ANDA	Current
65162-645	Esomeprazole Magnesium	Esomeprazole Magnesium	Amneal Pharmaceuticals LLC	ANDA	Current