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 7 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	Dr. Reddy's Laboratories Inc	fab0b1fa-cf56-d97c-f026-1754cf5b792c	2024-07-08	Warnings	Name fallback brand name: Esomeprazole Magnesium generic name: ESOMEPRAZOLE MAGNESIUM
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	WALGREEN CO.	179b23c4-2a6c-f658-e063-6394a90a82b3	2024-07-08	Warnings	Name fallback brand name: Esomeprazole Magnesium generic name: ESOMEPRAZOLE MAGNESIUM
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	Cardinal Health	90df7bbb-c55e-4a01-90b7-c118b65617a9	2024-06-27	Warnings	Name fallback brand name: Esomeprazole Magnesium generic name: ESOMEPRAZOLE MAGNESIUM
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	Dr. Reddy's Laboratories Inc	fca35363-7d27-b8b3-14c0-56f603652053	2024-06-24	Warnings	Name fallback brand name: Esomeprazole Magnesium generic name: ESOMEPRAZOLE MAGNESIUM
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	LITTLE PHARMA, INC.	e45621ea-cc15-4a8e-98d2-d10ab424a45e	2024-06-17	Warnings	Name fallback brand name: Esomeprazole Magnesium generic name: ESOMEPRAZOLE MAGNESIUM
Esomeprazole magnesium	ESOMEPRAZOLE MAGNESIUM	Rising Pharma Holdings, Inc.	83fa2aab-f00d-4428-b961-d960247d7169	2024-06-14	Warnings, Adverse reactions	Name fallback brand name: Esomeprazole magnesium generic name: ESOMEPRAZOLE MAGNESIUM
esomeprazole magnesium	ESOMEPRAZOLE MAGNESIUM	Bryant Ranch Prepack	925cee78-83af-480f-838d-8ba97ac6b1e3	2024-05-20	Warnings, Adverse reactions	Name fallback brand name: esomeprazole magnesium generic name: ESOMEPRAZOLE MAGNESIUM
esomeprazole magnesium	ESOMEPRAZOLE MAGNESIUM	Bryant Ranch Prepack	596e1cf8-dc6e-48b0-95ae-b463955870f7	2024-05-20	Warnings, Adverse reactions	Name fallback brand name: esomeprazole magnesium generic name: ESOMEPRAZOLE MAGNESIUM
ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM	Cipla USA Inc.	180490d1-c165-4bb9-96b1-12e727256e4e	2024-05-16	Warnings, Adverse reactions	Name fallback brand name: ESOMEPRAZOLE MAGNESIUM generic name: ESOMEPRAZOLE MAGNESIUM
Nexium 24HR	ESOMEPRAZOLE MAGNESIUM	A-S Medication Solutions	d56b330a-4355-4636-9d26-c592f67cea56	2024-05-14	Warnings	Name fallback generic name: ESOMEPRAZOLE MAGNESIUM
Esomeprazole magnesium	ESOMEPRAZOLE MAGNESIUM	Cipla USA Inc.	c1319da6-bf0d-4dd6-a713-1677bfbfbdae	2024-05-13	Warnings, Adverse reactions	Name fallback brand name: Esomeprazole magnesium generic name: ESOMEPRAZOLE MAGNESIUM
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	CVS Pharmacy, Inc.	d226cda0-5cdb-4e2d-a865-530a8f09a095	2024-04-27	Warnings	Name fallback brand name: Esomeprazole Magnesium generic name: ESOMEPRAZOLE MAGNESIUM
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	INNOVUS PHARMACEUTICALS, INC.	a32039b7-8475-4ec5-abaf-07f9aee3954b	2024-04-27	Warnings	Name fallback brand name: Esomeprazole Magnesium generic name: ESOMEPRAZOLE MAGNESIUM
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	Family Dollar Stores, LLC	f86ba9b5-736e-b279-e053-6394a90acf7c	2024-04-27	Warnings	Name fallback brand name: Esomeprazole Magnesium generic name: ESOMEPRAZOLE MAGNESIUM
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	Ahold U.S.A., Inc,	7bb719a0-9836-6752-e053-2a91aa0a2f48	2024-04-27	Warnings	Name fallback brand name: Esomeprazole Magnesium generic name: ESOMEPRAZOLE MAGNESIUM
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	Better Living Brands LLC	ee6e3f66-4eb9-4094-afcc-aaa020942b39	2024-04-27	Warnings	Name fallback brand name: Esomeprazole Magnesium generic name: ESOMEPRAZOLE MAGNESIUM
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	Best Choice	56120925-28e3-4e6c-b54d-490d7460984f	2024-04-27	Warnings	Name fallback brand name: Esomeprazole Magnesium generic name: ESOMEPRAZOLE MAGNESIUM
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	WALGREEN CO.	f9e10472-c6a3-402c-b6a2-f8700ad73e9f	2024-04-27	Warnings	Name fallback brand name: Esomeprazole Magnesium generic name: ESOMEPRAZOLE MAGNESIUM
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	Aurohealth LLC	f9a5431a-ea03-441f-9064-6e7f30b61674	2024-04-27	Warnings	Name fallback brand name: Esomeprazole Magnesium generic name: ESOMEPRAZOLE MAGNESIUM
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	Wal-Mart Stores, Inc.	c14f096d-ea1f-4539-8ad0-bb9907745cfc	2024-04-27	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