Application 209202

Type: ANDA
Sponsor: P AND L

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM	TABLET, 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
A209202-001	ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL			2019-03-05

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	A209202-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2019-03-05	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A209202-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2019-03-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209202-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2019-03-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209202-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2019-03-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209202-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2019-03-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209202-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2019-03-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209202-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2019-03-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209202-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2019-03-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209202-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2019-03-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209202-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2019-03-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209202-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2019-03-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209202-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2019-03-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209202-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2019-03-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209202-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2019-03-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209202-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2019-03-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209202-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2019-03-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209202-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2019-03-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209202-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2019-03-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209202-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2019-03-05	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209202-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2019-03-05	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209202-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2019-03-05	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209202-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2019-03-05	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209202-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2019-03-05	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209202-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2019-03-05	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209202-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2019-03-05	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209202-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2019-03-05	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209202-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2019-03-05	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209202-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2019-03-05	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209202-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2019-03-05	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209202-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2019-03-05	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209202-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2019-03-05	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209202-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2019-03-05	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209202-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2019-03-05	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209202-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2019-03-05	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209202-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2019-03-05	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209202-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2019-03-05	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209202-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2019-03-05	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209202-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2019-03-05	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209202-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2019-03-05	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209202-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2019-03-05	`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 5 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 CAPSULE, DELAYED RELEASE	Allegiant Health	42fa9084-89db-45ad-8212-4eeb53659a98	2025-01-30	Warnings	Name fallback brand name: Esomeprazole Magnesium
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	Asclemed USA, Inc.	2690dbe7-e559-4de8-9582-79b627af1964	2025-01-28	Warnings, Adverse reactions	Name fallback brand name: Esomeprazole Magnesium generic name: ESOMEPRAZOLE MAGNESIUM
ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM	Direct Rx	d5f56bd4-3a59-6857-e053-2995a90a6e00	2025-01-21	Warnings, Adverse reactions	Name fallback brand name: ESOMEPRAZOLE MAGNESIUM generic name: ESOMEPRAZOLE MAGNESIUM
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	Preferred Pharmaceuticals Inc.	e264d9c8-5ba9-49c1-9b27-d6ff9a6a45ba	2025-01-20	Warnings, Adverse reactions	Name fallback brand name: Esomeprazole Magnesium generic name: ESOMEPRAZOLE MAGNESIUM
esomeprazole magnesium	ESOMEPRAZOLE	CVS Pharmacy	6f1d75c1-3c0d-41c2-a625-1ee1bf642c32	2025-01-11	Warnings	Name fallback brand name: esomeprazole magnesium
Nexium 24HR	ESOMEPRAZOLE MAGNESIUM	Haleon US Holdings LLC	61f67858-ba2f-449b-8b30-c15cdaf49222	2025-01-09	Warnings	Name fallback generic name: ESOMEPRAZOLE MAGNESIUM
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	Major Pharmaceuticals	ba65c73d-fc7d-491e-aaaa-cf45a7783395	2025-01-07	Warnings, Adverse reactions	Name fallback brand name: Esomeprazole Magnesium generic name: ESOMEPRAZOLE MAGNESIUM
Esomeprazole magnesium	ESOMEPRAZOLE MAGNESIUM	Cipla USA Inc.	e89589f1-945e-429a-819e-61755cba77fa	2025-01-02	Warnings, Adverse reactions	Name fallback brand name: Esomeprazole magnesium generic name: ESOMEPRAZOLE MAGNESIUM
Esomeprazole Magnesium DR	ESOMEPRAZOLE MAGNESIUM	Advanced Rx Pharmacy of Tennessee, LLC	b4cd8ed1-d9d1-5b57-e053-2995a90a9f3c	2024-12-31	Warnings, Adverse reactions	Name fallback generic name: ESOMEPRAZOLE MAGNESIUM
Esomeprazole Magnesium DR	ESOMEPRAZOLE MAGNESIUM	Advanced Rx Pharmacy of Tennessee, LLC	fab87a2d-79c8-6045-e053-6394a90a2368	2024-12-31	Warnings, Adverse reactions	Name fallback generic name: ESOMEPRAZOLE MAGNESIUM
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	Guardian Drug Company	8d6c552c-16d9-4e0e-ba1a-04dce8052f95	2024-12-18	Warnings	Name fallback brand name: Esomeprazole Magnesium generic name: ESOMEPRAZOLE MAGNESIUM
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	Discount Drug Mart, Inc	0d6e66c5-ca6d-5cda-72d7-9350dbd1eba0	2024-12-16	Warnings	Name fallback brand name: Esomeprazole Magnesium generic name: ESOMEPRAZOLE MAGNESIUM
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	Bryant Ranch Prepack	3a879cfc-b0a4-48ca-aa6a-b5e9051601aa	2024-12-12	Warnings, Adverse reactions	Name fallback brand name: Esomeprazole Magnesium generic name: ESOMEPRAZOLE MAGNESIUM
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	DISCOUNT DRUG MART, INC.	144fcd6b-2b40-f84b-c559-07a847b27638	2024-11-30	Warnings	Name fallback brand name: Esomeprazole Magnesium generic name: ESOMEPRAZOLE MAGNESIUM
esomeprazole magnesium	ESOMEPRAZOLE MAGNESIUM	Zydus Lifesciences Limited	6f314f5d-453c-4876-b9b8-20663008dfb1	2024-11-28		Name fallback brand name: esomeprazole magnesium generic name: ESOMEPRAZOLE MAGNESIUM
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	Zydus Lifesciences Limited	4cd9e802-c519-4593-bc38-947ad7f9b567	2024-11-28		Name fallback brand name: Esomeprazole Magnesium generic name: ESOMEPRAZOLE MAGNESIUM
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	Somerset Therapeutics, LLC	02893318-e394-5a8e-e063-6394a90a885a	2024-11-11	Warnings, Adverse reactions	Name fallback brand name: Esomeprazole Magnesium generic name: ESOMEPRAZOLE MAGNESIUM
esomeprazole magnesium	ESOMEPRAZOLE MAGNESIUM	Zydus Pharmaceuticals USA Inc.	c4b0571e-7b09-441b-90be-bc653806812b	2024-11-11	Warnings, Adverse reactions	Name fallback brand name: esomeprazole magnesium generic name: ESOMEPRAZOLE MAGNESIUM
Esomeprazole	ESOMEPRAZOLE MAGNESIUM	INNOVUS PHARMACEUTICALS, INC.	b3d10f0b-52af-408c-9b3d-f8f25f7c42bd	2024-10-30	Warnings	Name fallback generic name: ESOMEPRAZOLE MAGNESIUM
Esomeprazole magnesium	ESOMEPRAZOLE MAGNESIUM	Advanced Rx of Tennessee, LLC	25a48082-ca99-42a4-e063-6394a90ae559	2024-10-29	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 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0591-4187	Esomeprazole	Esomeprazole	Actavis Pharma, Inc.	ANDA	Current
0591-4187	Esomeprazole	Esomeprazole	Actavis Pharma, Inc.	ANDA	Current
0591-4187	Esomeprazole	Esomeprazole	Actavis Pharma, Inc.	ANDA	Current
0591-4187	Esomeprazole	Esomeprazole	Actavis Pharma, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
57982	ORIG	2019-03-13