Application 212376

Type: ANDA
Sponsor: MYLAN

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
A212376-001	ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL			2019-10-16

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 · 41 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	A212376-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2019-10-16	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A212376-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2019-10-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212376-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2019-10-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212376-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2019-10-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212376-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2019-10-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212376-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2019-10-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212376-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2019-10-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212376-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2019-10-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212376-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2019-10-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212376-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2019-10-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212376-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2019-10-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212376-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2019-10-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212376-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2019-10-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212376-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2019-10-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212376-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2019-10-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212376-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2019-10-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212376-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2019-10-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212376-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2019-10-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212376-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2019-10-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A212376-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2019-10-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A212376-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2019-10-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212376-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2019-10-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212376-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2019-10-16	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A212376-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2019-10-16	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A212376-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2019-10-16	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A212376-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2019-10-16	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A212376-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2019-10-16	`3f01610625f2…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212376-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2019-10-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212376-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2019-10-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212376-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2019-10-16	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212376-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2019-10-16	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212376-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2019-10-16	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212376-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2019-10-16	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212376-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2019-10-16	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212376-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2019-10-16	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212376-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2019-10-16	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212376-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2019-10-16	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212376-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2019-10-16	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212376-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2019-10-16	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212376-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2019-10-16	`cb3db0bc1861…`

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 2 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	NCS HealthCare of KY, LLC dba Vangard Labs	28fbfa02-6c7b-4eb1-af24-86825e652326	2026-04-14	Warnings, Adverse reactions	Name fallback brand name: Esomeprazole Magnesium generic name: ESOMEPRAZOLE MAGNESIUM
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	Preferred Pharmaceuticals Inc.	a9d05a38-08db-4710-b6f3-20c92ce885d5	2026-04-13	Warnings, Adverse reactions	Name fallback brand name: Esomeprazole Magnesium generic name: ESOMEPRAZOLE MAGNESIUM
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	A-S Medication Solutions	b58bfbdb-939e-456e-827d-068e9d808840	2026-04-13	Warnings, Adverse reactions	Name fallback brand name: Esomeprazole Magnesium generic name: ESOMEPRAZOLE MAGNESIUM
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	A-S Medication Solutions	8a8ca4cf-076c-48c9-8613-f5a1bae87a49	2026-04-13	Warnings, Adverse reactions	Name fallback brand name: Esomeprazole Magnesium generic name: ESOMEPRAZOLE MAGNESIUM
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	AvPAK	4db9f4b8-b6df-f6e9-e063-6294a90a9f60	2026-03-31	Warnings, Adverse reactions	Name fallback brand name: Esomeprazole Magnesium generic name: ESOMEPRAZOLE MAGNESIUM
Acid Reducer	ESOMEPRAZOLE MAGNESIUM	Walgreens	4f3c1d76-e1ba-4f85-9384-ed8f35fa6bc6	2026-03-25	Warnings	Name fallback generic name: ESOMEPRAZOLE MAGNESIUM
esomeprazole magnesium	ESOMEPRAZOLE MAGNESIUM DIHYDRATE	HyVee Inc	c2308fc8-1549-476d-9769-2991051360ad	2026-03-24	Warnings	Name fallback brand name: esomeprazole magnesium
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	REMEDYREPACK INC.	ab3d31c8-cab1-4c44-bacd-5e5c67dd1384	2026-03-06	Warnings, Adverse reactions	Name fallback brand name: Esomeprazole Magnesium generic name: ESOMEPRAZOLE MAGNESIUM
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM DIHYDRATE	Walgreen Company	29eb7b87-59a4-4d27-ad53-789da7fec427	2026-02-28	Warnings	Name fallback brand name: Esomeprazole Magnesium
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	Aurohealth LLC	034bcbad-f57f-4338-a193-7a5aa9f09aa6	2026-02-12	Warnings	Name fallback brand name: Esomeprazole Magnesium generic name: ESOMEPRAZOLE MAGNESIUM
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	A-S Medication Solutions	27e7f7f0-7403-4425-8baa-d12ae9321364	2026-02-11	Warnings, Adverse reactions	Name fallback brand name: Esomeprazole Magnesium generic name: ESOMEPRAZOLE MAGNESIUM
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	YYBA CORP	4a7f3a55-862f-111f-e063-6294a90a6a44	2026-02-10	Warnings	Name fallback brand name: Esomeprazole Magnesium generic name: ESOMEPRAZOLE MAGNESIUM
esomeprazole magnesium	ESOMEPRAZOLE	HyVee Inc	b0968243-171e-428a-b692-740e0c05a0fc	2026-01-29	Warnings	Name fallback brand name: esomeprazole magnesium
esomeprazole magnesium	ESOMEPRAZOLE MAGNESIUM	GLENMARK THERAPEUTICS INC., USA	da5ec2c4-833e-4d2a-a61f-b43835c7f473	2026-01-23	Warnings	Name fallback brand name: esomeprazole magnesium generic name: ESOMEPRAZOLE MAGNESIUM
Acid Reducer	ESOMEPRAZOLE MAGNESIUM	CVS Pharmacy	001817ea-906e-47f7-8605-41ba5a9abd21	2026-01-21	Warnings	Name fallback generic name: ESOMEPRAZOLE MAGNESIUM
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	A-S Medication Solutions	00aa81c2-73c7-4bf8-94e9-f644381b631f	2026-01-20	Warnings, Adverse reactions	Name fallback brand name: Esomeprazole Magnesium generic name: ESOMEPRAZOLE MAGNESIUM
NEXIUM	ESOMEPRAZOLE MAGNESIUM	AstraZeneca Pharmaceuticals LP	f4853677-1622-4037-688b-fdf533a11d96	2025-12-19	Warnings, Adverse reactions	Name fallback generic name: ESOMEPRAZOLE MAGNESIUM
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	NuCare Pharmaceuticals, Inc.	463c9b3b-dd6b-7ee7-e063-6394a90afb43	2025-12-18	Warnings, Adverse reactions	Name fallback brand name: Esomeprazole Magnesium generic name: ESOMEPRAZOLE MAGNESIUM
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	Lannett Company, Inc.	eb8f8b81-d482-4b94-be87-c766f49e753f	2025-11-20	Warnings, Adverse reactions	Name fallback brand name: Esomeprazole Magnesium generic name: ESOMEPRAZOLE MAGNESIUM
Esomeprazole	ESOMEPRAZOLE MAGNESIUM	YYBA CORP	0912d311-e26c-479d-9f13-ef0ac403e9b8	2025-11-19	Warnings	Name fallback generic name: ESOMEPRAZOLE MAGNESIUM

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.