Application 209339

Type: ANDA
Sponsor: AUROBINDO PHARMA LTD

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
A209339-001	ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL			2017-10-16

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 · 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	A209339-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2017-10-16	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A209339-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2017-10-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209339-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2017-10-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209339-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2017-10-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209339-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2017-10-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209339-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2017-10-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209339-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2017-10-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209339-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2017-10-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209339-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2017-10-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209339-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2017-10-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209339-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2017-10-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209339-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2017-10-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209339-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2017-10-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209339-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2017-10-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209339-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2017-10-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209339-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2017-10-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209339-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2017-10-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209339-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2017-10-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209339-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2017-10-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209339-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2017-10-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209339-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2017-10-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209339-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2017-10-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209339-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2017-10-16	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209339-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2017-10-16	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209339-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2017-10-16	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209339-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2017-10-16	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209339-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2017-10-16	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209339-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2017-10-16	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209339-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2017-10-16	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209339-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2017-10-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209339-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2017-10-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209339-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2017-10-16	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209339-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2017-10-16	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209339-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2017-10-16	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209339-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2017-10-16	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209339-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2017-10-16	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209339-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2017-10-16	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209339-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2017-10-16	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209339-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2017-10-16	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209339-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2017-10-16	`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 1 of 1 · 20 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	Aurohealth LLC	d0733d37-cc9c-41ba-9c5f-a0f8bf5a2364	2026-05-27	Warnings	Exact identifier application applno (ANDA): 209339 application number: ANDA209339
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	YYBA CORP	4a7f3a55-862f-111f-e063-6294a90a6a44	2026-02-10	Warnings	Exact identifier application applno (ANDA): 209339 application number: ANDA209339
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	LEADER/ CARDINAL HEALTH 110, INC.	aef20ccb-1eb7-4c79-af8e-81220eb73752	2025-11-18	Warnings	Exact identifier application applno (ANDA): 209339 application number: ANDA209339
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	Aurohealth LLC	212cca98-786f-4677-b687-fff81a1dd59f	2025-11-14	Warnings	Exact identifier application applno (ANDA): 209339 application number: ANDA209339
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	Amerisource Bergen	3c6c2fd5-1a0f-44f7-8d02-c9bc26b8db46	2025-08-30	Warnings	Exact identifier application applno (ANDA): 209339 application number: ANDA209339
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	Aurohealth LLC	b594f052-b6be-4d3b-9316-29cab050344a	2025-05-20	Warnings	Exact identifier application applno (ANDA): 209339 application number: ANDA209339
ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM	LEADER/ CARDINAL HEALTH 110, INC.	c98b4332-ce47-422e-be54-f3eee0762354	2025-04-24	Warnings	Exact identifier application applno (ANDA): 209339 application number: ANDA209339
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	Aurohealth LLC	5647bfb0-6af0-4580-b202-0f1fc9c41265	2025-03-13	Warnings	Exact identifier application applno (ANDA): 209339 application number: ANDA209339
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	Publix	c45fd180-9d81-41e0-b7f8-025b8f29763a	2025-02-21	Warnings	Exact identifier application applno (ANDA): 209339 application number: ANDA209339
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	CVS Pharmacy, Inc.	d226cda0-5cdb-4e2d-a865-530a8f09a095	2024-04-27	Warnings	Exact identifier application applno (ANDA): 209339 application number: ANDA209339
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	INNOVUS PHARMACEUTICALS, INC.	a32039b7-8475-4ec5-abaf-07f9aee3954b	2024-04-27	Warnings	Exact identifier application applno (ANDA): 209339 application number: ANDA209339
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	Family Dollar Stores, LLC	f86ba9b5-736e-b279-e053-6394a90acf7c	2024-04-27	Warnings	Exact identifier application applno (ANDA): 209339 application number: ANDA209339
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	Ahold U.S.A., Inc,	7bb719a0-9836-6752-e053-2a91aa0a2f48	2024-04-27	Warnings	Exact identifier application applno (ANDA): 209339 application number: ANDA209339
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	Better Living Brands LLC	ee6e3f66-4eb9-4094-afcc-aaa020942b39	2024-04-27	Warnings	Exact identifier application applno (ANDA): 209339 application number: ANDA209339
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	Best Choice	56120925-28e3-4e6c-b54d-490d7460984f	2024-04-27	Warnings	Exact identifier application applno (ANDA): 209339 application number: ANDA209339
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	WALGREEN CO.	f9e10472-c6a3-402c-b6a2-f8700ad73e9f	2024-04-27	Warnings	Exact identifier application applno (ANDA): 209339 application number: ANDA209339
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	Aurohealth LLC	f9a5431a-ea03-441f-9064-6e7f30b61674	2024-04-27	Warnings	Exact identifier application applno (ANDA): 209339 application number: ANDA209339
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	Wal-Mart Stores, Inc.	c14f096d-ea1f-4539-8ad0-bb9907745cfc	2024-04-27	Warnings	Exact identifier application applno (ANDA): 209339 application number: ANDA209339
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	Amerisource Bergen	c94eb997-07d4-4d2e-b213-9a0d51db41c0	2024-03-29	Warnings	Exact identifier application applno (ANDA): 209339 application number: ANDA209339
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	Retail Business Services, LLC.	ce376d91-0ea8-4922-9f7f-707420cb1d96	2021-03-12	Warnings	Exact identifier application applno (ANDA): 209339 application number: ANDA209339 ndc (product): 72476-500

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 2 of 2 · 86 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
72036-800	Esomeprazole Magnesium	Esomeprazole Magnesium	Harris Teeter	ANDA	Current
72476-500	Esomeprazole Magnesium	Esomeprazole Magnesium	Retail Business Services, LLC.	ANDA	Current
72476-500	Esomeprazole Magnesium	Esomeprazole Magnesium	Retail Business Services, LLC.	ANDA	Current
72476-500	Esomeprazole Magnesium	Esomeprazole Magnesium	Retail Business Services, LLC.	ANDA	Current
72476-500	Esomeprazole Magnesium	Esomeprazole Magnesium	Retail Business Services, LLC.	ANDA	Current
72476-500	Esomeprazole Magnesium	Esomeprazole Magnesium	Retail Business Services, LLC.	ANDA	Current