Application 207193

Type: ANDA
Sponsor: PERRIGO R AND D

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
A207193-001	ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL			2017-08-18

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
2026-02-19 14:30 UTC	2026-02	A207193-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2017-08-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207193-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2017-08-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207193-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2017-08-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207193-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2017-08-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207193-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2017-08-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207193-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2017-08-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207193-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2017-08-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207193-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2017-08-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207193-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2017-08-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207193-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2017-08-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207193-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2017-08-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207193-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2017-08-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207193-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2017-08-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207193-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2017-08-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207193-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2017-08-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207193-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2017-08-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207193-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2017-08-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207193-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2017-08-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207193-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2017-08-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207193-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2017-08-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207193-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2017-08-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207193-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2017-08-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207193-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2017-08-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207193-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2017-08-18	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207193-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2017-08-18	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207193-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2017-08-18	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207193-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2017-08-18	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207193-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2017-08-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207193-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2017-08-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207193-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2017-08-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207193-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2017-08-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207193-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2017-08-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207193-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2017-08-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207193-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2017-08-18	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207193-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2017-08-18	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207193-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2017-08-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207193-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2017-08-18	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207193-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2017-08-18	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207193-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2017-08-18	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A207193-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2017-08-18	`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 1 of 3 · 41 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ESOMEPRAZOLE MAGNESIUM MINIS	ESOMEPRAZOLE MAGNESIUM DIHYDRATE	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	c1435a38-b816-45a1-a0f6-4ad0c5b6da58	2026-07-27	Warnings	Exact identifier application applno (ANDA): 207193 application number: ANDA207193
esomeprazole magnesium	ESOMEPRAZOLE	Rite Aid Corporation	6996642f-a63e-4be9-aefd-0634e9914c2b	2026-07-07	Warnings	Exact identifier application applno (ANDA): 207193 application number: ANDA207193
Basic Care Esomeprazole Magnesium	ESOMEPRAZOLE	Amazon.com Services LLC	42dd2e93-776c-4f49-b590-afc7dab6ef2f	2026-06-17	Warnings	Exact identifier application applno (ANDA): 207193 application number: ANDA207193
good sense esomeprazole magnesium	ESOMEPRAZOLE	L. Perrigo Company	f13088de-6841-453e-acb0-08bbdf9529d1	2026-05-20	Warnings	Exact identifier application applno (ANDA): 207193 application number: ANDA207193
esomeprazole magnesium	ESOMEPRAZOLE MAGNESIUM DIHYDRATE	HyVee Inc	c2308fc8-1549-476d-9769-2991051360ad	2026-03-24	Warnings	Exact identifier application applno (ANDA): 207193 application number: ANDA207193
EQUATE ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE	WALMART INC.	ce5f2915-327d-4a91-b7fd-e399664a250f	2026-03-19	Warnings	Exact identifier application applno (ANDA): 207193 application number: ANDA207193
Foster and Thrive Acid Reducer	ESOMEPRAZOLE	Strategic Sourcing Services LLC	32933772-c0ef-46ad-84e5-d70218bcc866	2026-03-07	Warnings	Exact identifier application applno (ANDA): 207193 application number: ANDA207193
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM DIHYDRATE	Walgreen Company	29eb7b87-59a4-4d27-ad53-789da7fec427	2026-02-28	Warnings	Exact identifier application applno (ANDA): 207193 application number: ANDA207193
members mark esomeprazole magnesium	ESOMEPRAZOLE	Sam's West Inc	87913038-4b90-40a0-bce5-2d368bd5758c	2026-02-07	Warnings	Exact identifier application applno (ANDA): 207193 application number: ANDA207193 ndc (product): 68196-898
esomeprazole magnesium	ESOMEPRAZOLE	HyVee Inc	b0968243-171e-428a-b692-740e0c05a0fc	2026-01-29	Warnings	Exact identifier application applno (ANDA): 207193 application number: ANDA207193
equate esomeprazole magnesium	ESOMEPRAZOLE	Wal-Mart Stores Inc	aaafc536-f846-4019-a629-b52b3f36e682	2026-01-19	Warnings	Exact identifier application applno (ANDA): 207193 application number: ANDA207193
berkley and jensen heartburn treatment	ESOMEPRAZOLE	BJWC	2369c948-d46f-4ace-bc51-47477631bc43	2026-01-19	Warnings	Exact identifier application applno (ANDA): 207193 application number: ANDA207193 ndc (product): 68391-898
careone esomeprazole magnesium	ESOMEPRAZOLE	American Sales Company	3f9a2747-8afd-4898-bbfb-5f379293137e	2025-11-03	Warnings	Exact identifier application applno (ANDA): 207193 application number: ANDA207193
Esomeprazole Magnesium	ESOMEPRAZOLE	Publix Super Markets Inc	60554fd6-96d5-4e73-b676-332116caa800	2025-09-29	Warnings	Exact identifier application applno (ANDA): 207193 application number: ANDA207193
equate esomeprazole magnesium	ESOMEPRAZOLE MAGNESIUM DIHYDRATE	WALMART INC.	2d40c4bf-5b66-420c-9f17-3f31edc40d1a	2025-09-11	Warnings	Exact identifier application applno (ANDA): 207193 application number: ANDA207193
Up and Up Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	Target Corporation	b3d3ad1d-96f8-4f72-ae66-f14940a62882	2025-06-02	Warnings	Exact identifier application applno (ANDA): 207193 application number: ANDA207193
leader esomeprazole magnesium	ESOMEPRAZOLE	Cardinal Health 110, LLC. dba Leader	c9472b82-d345-4531-bf07-bd55c94876ab	2025-04-23	Warnings	Exact identifier application applno (ANDA): 207193 application number: ANDA207193
esomeprazole magnesium	ESOMEPRAZOLE	CVS Pharmacy	6f1d75c1-3c0d-41c2-a625-1ee1bf642c32	2025-01-11	Warnings	Exact identifier application applno (ANDA): 207193 application number: ANDA207193 ndc (product): 69842-898
topcare esomeprazole magnesium	ESOMEPRAZOLE MAGNESIUM	Topco Associates LLC	86384845-0bea-490b-b04a-5770ef88b639	2024-09-01	Warnings	Exact identifier application applno (ANDA): 207193 application number: ANDA207193
Good Sense Esomeprazole Magnesium	ESOMEPRAZOLE	L. Perrigo Company	4a89b4b5-5c42-44ee-98a9-e26a237aaef7	2024-08-27	Warnings	Exact identifier application applno (ANDA): 207193 application number: ANDA207193

NDC Listings For This Application#

NDC listings for this application page 2 of 2 · 106 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
62011-0332	health mart esomeprazole magnesium	Esomeprazole	Mckesson	ANDA	Current
62011-0332	health mart esomeprazole magnesium	Esomeprazole	Mckesson	ANDA	Current
62011-0332	health mart esomeprazole magnesium	Esomeprazole	Strategic Sourcing Services LLC	ANDA	Current
63981-898	kirkland signature esomeprazole magnesium	Esomeprazole	Costco Wholesale Company	ANDA	Current
63981-898	kirkland signature esomeprazole magnesium	Esomeprazole	Costco Wholesale Company	ANDA	Current
63981-898	kirkland signature esomeprazole magnesium	Esomeprazole	Costco Wholesale Company	ANDA	Current
68196-898	members mark esomeprazole magnesium	esomeprazole	Sam's West Inc	ANDA	Current
68391-898	berkley and jensen heartburn treatment	Esomeprazole	BJWC	ANDA	Current
68391-898	berkley and jensen heartburn treatment	Esomeprazole	BJWC	ANDA	Current
68391-898	berkley and jensen heartburn treatment	Esomeprazole	BJWC	ANDA	Current
68391-898	berkley and jensen heartburn treatment	Esomeprazole	BJWC	ANDA	Current
69256-007	harris teeter acid reducer	Esomeprazole	Harris Teeter, LLC	ANDA	Current
69256-007	harris teeter acid reducer	Esomeprazole	Harris Teeter, LLC	ANDA	Current
69842-703	esomeprazole magnesium	esomeprazole magnesium	CVS Pharmacy	ANDA	Current
69842-898	esomeprazole magnesium	Esomeprazole	CVS Pharmacy	ANDA	Current
69842-898	esomeprazole magnesium	Esomeprazole	CVS Pharmacy	ANDA	Current
70000-0255	Leader Heartburn Treatment	Esomeprazole	Cardinal Health	ANDA	Current
70000-0255	Leader Heartburn Treatment	Esomeprazole	Cardinal Health	ANDA	Current
70677-0016	sunmark esomeprazole magnesium	Esomeprazole	Strategic Sourcing Services LLC	ANDA	Current
70677-0016	sunmark esomeprazole magnesium	Esomeprazole	Strategic Sourcing Services LLC	ANDA	Current
70677-0016	sunmark esomeprazole magnesium	Esomeprazole	McKesson	ANDA	Current
70677-0016	sunmark esomeprazole magnesium	Esomeprazole	McKesson	ANDA	Current
71713-302	Esomeprazole Magnesium	Esomeprazole	THIRTY MADISON INC	ANDA	Current
72288-700	basic care esomeprazole magnesium	esomeprazole	Amazon.com Services Inc.	ANDA	Current
72288-898	basic care esomeprazole magnesium	Esomeprazole	Amazon.com Services Inc.	ANDA	Current
72288-898	basic care esomeprazole magnesium	Esomeprazole	Amazon.com Services LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
65832	SUPPL	2021-01-06
65831	SUPPL	2021-01-06
49516	ORIG	2017-08-22
49508	ORIG	2017-08-22