Application 212866

Type: ANDA
Sponsor: SUN PHARM

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 1.

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
A212866-001	ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL			2020-05-04

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A212866-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2020-05-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212866-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2020-05-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212866-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2020-05-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212866-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2020-05-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212866-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2020-05-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212866-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2020-05-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212866-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2020-05-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212866-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2020-05-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212866-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2020-05-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212866-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2020-05-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212866-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2020-05-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212866-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2020-05-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212866-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2020-05-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212866-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2020-05-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212866-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2020-05-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212866-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2020-05-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212866-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2020-05-04	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212866-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2020-05-04	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212866-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2020-05-04	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212866-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2020-05-04	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A212866-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2020-05-04	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A212866-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2020-05-04	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A212866-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2020-05-04	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212866-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2020-05-04	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212866-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2020-05-04	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212866-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2020-05-04	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212866-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2020-05-04	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212866-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2020-05-04	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212866-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2020-05-04	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212866-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2020-05-04	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212866-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2020-05-04	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212866-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2020-05-04	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212866-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2020-05-04	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212866-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2020-05-04	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212866-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2020-05-04	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212866-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2020-05-04	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212866-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2020-05-04	`a50c72e98297…`

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 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Esomeprazole	ESOMEPRAZOLE MAGNESIUM	Ohm Laboratories Inc.	e6d19b0a-44a8-42fe-8a6c-717ecb3ac1c4	2026-06-06	Warnings	Exact identifier application applno (ANDA): 212866 application number: ANDA212866 ndc (product): 51660-027
Esomeprazole	ESOMEPRAZOLE MAGNESIUM	YYBA CORP	0912d311-e26c-479d-9f13-ef0ac403e9b8	2025-11-19	Warnings	Exact identifier application applno (ANDA): 212866 application number: ANDA212866
Esomeprazole	ESOMEPRAZOLE MAGNESIUM	CVS	b68035d0-195a-41e8-9928-8b1bd57917c0	2025-09-15	Warnings	Exact identifier application applno (ANDA): 212866 application number: ANDA212866 ndc (product): 51316-715
Esomeprazole	ESOMEPRAZOLE MAGNESIUM	INNOVUS PHARMACEUTICALS, INC.	b3d10f0b-52af-408c-9b3d-f8f25f7c42bd	2024-10-30	Warnings	Exact identifier application applno (ANDA): 212866 application number: ANDA212866 ndc (product): 57483-900
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	LITTLE PHARMA, INC.	e45621ea-cc15-4a8e-98d2-d10ab424a45e	2024-06-17	Warnings	Exact identifier application applno (ANDA): 212866 application number: ANDA212866 ndc (product): 72559-011
Esomeprazole	ESOMEPRAZOLE MAGNESIUM	VALU MERCHANDISERS COMPANY	ab83bbdd-2c8e-46bd-b39e-69199e004be4	2023-11-03	Warnings	Exact identifier application applno (ANDA): 212866 application number: ANDA212866
Esomeprazole	ESOMEPRAZOLE	Safeway, Inc.	7c497204-29ce-45e0-84d4-91b981c9b7aa	2023-08-25	Warnings	Exact identifier application applno (ANDA): 212866 application number: ANDA212866
Esomeprazole	ESOMEPRAZOLE MAGNESIUM	HARRIS TEETER	ea9ef7b0-7397-470f-b852-397e8b0e66e4	2021-04-30	Warnings	Exact identifier application applno (ANDA): 212866 application number: ANDA212866 ndc (product): 72036-982
esomeprazole	ESOMEPRAZOLE	THE KROGER COMPANY	7fa75bbe-5b9f-49ca-84de-f80e5a858de4	2020-10-28	Warnings	Exact identifier application applno (ANDA): 212866 application number: ANDA212866 ndc (product): 30142-989

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 16 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
30142-989	esomeprazole	esomeprazole	THE KROGER COMPANY	ANDA	Current
30142-989	esomeprazole	esomeprazole	THE KROGER COMPANY	ANDA	Current
51316-715	Esomeprazole	ESOMEPRAZOLE MAGNESIUM	CVS	ANDA	Current
51660-027	Esomeprazole	esomeprazole magnesium	Ohm Laboratories Inc.	ANDA	Current
51660-027	Esomeprazole	esomeprazole magnesium	Ohm Laboratories Inc.	ANDA	Current
57483-900	Esomeprazole	esomeprazole magnesium	INNOVUS PHARMACEUTICALS, INC.	ANDA	Current
57483-900	Esomeprazole	esomeprazole magnesium	INNOVUS PHARMACEUTICALS, INC.	ANDA	Current
63304-740	Esomeprazole	Esomeprazole	Sun Pharmaceutical Industries, Inc.	ANDA	Current
72036-982	Esomeprazole	Esomeprazole Magnesium	HARRIS TEETER	ANDA	Current
72036-982	Esomeprazole	Esomeprazole Magnesium	HARRIS TEETER	ANDA	Current
72559-011	Esomeprazole Magnesium	Esomeprazole Magnesium	LITTLE PHARMA, INC.	ANDA	Current
72559-011	Esomeprazole Magnesium	Esomeprazole Magnesium	LITTLE PHARMA, INC.	ANDA	Current
72559-011	Esomeprazole Magnesium	Esomeprazole Magnesium	LITTLE PHARMA, INC.	ANDA	Current
72559-011	Esomeprazole Magnesium	Esomeprazole Magnesium	LITTLE PHARMA, INC.	ANDA	Current
72559-011	Esomeprazole Magnesium	Esomeprazole Magnesium	LITTLE PHARMA, INC.	ANDA	Current
72559-011	Esomeprazole Magnesium	Esomeprazole Magnesium	LITTLE PHARMA, INC.	ANDA	Current