Application 209716

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 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
A209716-001	ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL			2019-06-05

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 · 43 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	A209716-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2019-06-05	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A209716-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2019-06-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209716-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2019-06-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209716-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2019-06-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209716-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2019-06-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209716-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2019-06-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209716-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2019-06-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209716-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2019-06-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209716-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2019-06-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209716-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2019-06-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209716-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2019-06-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209716-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2019-06-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209716-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2019-06-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209716-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2019-06-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209716-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2019-06-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209716-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2019-06-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209716-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2019-06-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209716-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2019-06-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209716-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2019-06-05	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209716-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2019-06-05	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209716-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2019-06-05	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209716-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2019-06-05	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209716-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2019-06-05	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209716-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2019-06-05	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209716-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2019-06-05	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209716-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2019-06-05	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209716-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2019-06-05	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209716-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2019-06-05	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209716-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2019-06-05	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209716-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2019-06-05	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209716-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2019-06-05	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209716-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2019-06-05	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209716-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2019-06-05	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209716-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2019-06-05	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209716-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2019-06-05	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209716-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2019-06-05	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209716-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2019-06-05	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209716-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2019-06-05	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209716-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2019-06-05	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209716-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2019-06-05	`f41ea6bd6efb…`

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 4 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	CVS Pharmacy	0b3b2f9b-f7f3-1a32-4e14-f10aecd6aabb	2025-08-30	Warnings	Name fallback brand name: Esomeprazole Magnesium generic name: ESOMEPRAZOLE MAGNESIUM
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	Amerisource Bergen	3c6c2fd5-1a0f-44f7-8d02-c9bc26b8db46	2025-08-30	Warnings	Name fallback brand name: Esomeprazole Magnesium generic name: ESOMEPRAZOLE MAGNESIUM
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	PD-Rx Pharmaceuticals, Inc.	ac12cd05-10cf-4694-a9e8-e5f04fe162a7	2025-06-20	Warnings, Adverse reactions	Name fallback brand name: Esomeprazole Magnesium generic name: ESOMEPRAZOLE MAGNESIUM
Esomeprazole magnesium	ESOMEPRAZOLE MAGNESIUM DELAYED RELEASE CAPSULES	Ascend Laboratories, LLC	277ce748-2809-4be0-81e7-6a4d604f2c6f	2025-06-11	Warnings, Adverse reactions	Name fallback brand name: Esomeprazole magnesium
Up and Up Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	Target Corporation	b3d3ad1d-96f8-4f72-ae66-f14940a62882	2025-06-02	Warnings	Name fallback generic name: ESOMEPRAZOLE MAGNESIUM
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	Aurohealth LLC	b594f052-b6be-4d3b-9316-29cab050344a	2025-05-20	Warnings	Name fallback brand name: Esomeprazole Magnesium generic name: ESOMEPRAZOLE MAGNESIUM
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	NuCare Pharmaceuticals,Inc.	2879c79f-bf2a-0bc9-e063-6394a90a98ae	2025-04-28	Warnings, Adverse reactions	Name fallback brand name: Esomeprazole Magnesium generic name: ESOMEPRAZOLE MAGNESIUM
ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM	LEADER/ CARDINAL HEALTH 110, INC.	c98b4332-ce47-422e-be54-f3eee0762354	2025-04-24	Warnings	Name fallback brand name: ESOMEPRAZOLE MAGNESIUM generic name: ESOMEPRAZOLE MAGNESIUM
Esomeprazole Magnesium Delayed Release	ESOMEPRAZOLE MAGNESIUM	WALGREENS	2fa5d747-a014-2475-e063-6294a90ab918	2025-04-21	Warnings	Name fallback generic name: ESOMEPRAZOLE MAGNESIUM
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	Aurobindo Pharma Limited	3c7a6b13-c67d-48f7-b170-1437a420d704	2025-04-16	Warnings, Adverse reactions	Name fallback brand name: Esomeprazole Magnesium generic name: ESOMEPRAZOLE MAGNESIUM
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	Aurobindo Pharma Limited	e691b51e-2e31-4408-81c4-5afec6f9bbb6	2025-04-16	Warnings, Adverse reactions	Name fallback brand name: Esomeprazole Magnesium generic name: ESOMEPRAZOLE MAGNESIUM
esomeprazole magnesium	ESOMEPRAZOLE MAGNESIUM	Preferred Pharmaceuticals Inc.	2d21ed0b-a089-46f4-9ebb-f24f9f3af61d	2025-04-16	Warnings, Adverse reactions	Name fallback brand name: esomeprazole magnesium generic name: ESOMEPRAZOLE MAGNESIUM
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	Aurobindo Pharma Limited	7038a0bc-99b2-4a6e-9b9a-0646ec187706	2025-04-08	Warnings, Adverse reactions	Name fallback brand name: Esomeprazole Magnesium generic name: ESOMEPRAZOLE MAGNESIUM
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	Camber Consumer Care Inc	d2554c3d-eb0b-4bf8-aebc-18be7b195c8e	2025-04-05	Warnings	Name fallback brand name: Esomeprazole Magnesium generic name: ESOMEPRAZOLE MAGNESIUM
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	Aurobindo Pharma Limited	f4ae091d-9b74-4a0e-ac68-057effd91e17	2025-03-26	Warnings, Adverse reactions	Name fallback brand name: Esomeprazole Magnesium generic name: ESOMEPRAZOLE MAGNESIUM
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	Aurohealth LLC	5647bfb0-6af0-4580-b202-0f1fc9c41265	2025-03-13	Warnings	Name fallback brand name: Esomeprazole Magnesium generic name: ESOMEPRAZOLE MAGNESIUM
ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM	Quallent Pharmaceuticals Health LLC	7362f930-0879-451e-8de9-8bb8565bfb7e	2025-02-28	Warnings, Adverse reactions	Name fallback brand name: ESOMEPRAZOLE MAGNESIUM generic name: ESOMEPRAZOLE MAGNESIUM
esomeprazole magnesium	ESOMEPRAZOLE MAGNESIUM	Biocon Pharma Inc.,	66c9e2bf-2dc4-4683-89fd-6dadf1b01ee9	2025-02-28	Warnings, Adverse reactions	Name fallback brand name: esomeprazole magnesium generic name: ESOMEPRAZOLE MAGNESIUM
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	Publix	c45fd180-9d81-41e0-b7f8-025b8f29763a	2025-02-21	Warnings	Name fallback brand name: Esomeprazole Magnesium generic name: ESOMEPRAZOLE MAGNESIUM
esomeprazole magnesium	ESOMEPRAZOLE MAGNESIUM	NuCare Pharmaceuticals,Inc.	fe7d7aa8-4f46-83ae-e053-6394a90a01d6	2025-02-04	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.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
59726-912	Esomeprazole Magnesium	Esomeprazole magnesium	P & L Development, LLC	ANDA	Current
69238-1050	Esomeprazole Magnesium	Esomeprazole Magnesium	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1050	Esomeprazole Magnesium	Esomeprazole Magnesium	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1050	Esomeprazole Magnesium	Esomeprazole Magnesium	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1050	Esomeprazole Magnesium	Esomeprazole Magnesium	Amneal Pharmaceuticals NY LLC	ANDA	Current