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 44.

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 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	A207193-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2017-08-18	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A207193-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2017-08-18	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A207193-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2017-08-18	`caaa826d4ba7…`
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…`

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 3 · 41 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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
esomeprazole magnesium	ESOMEPRAZOLE MAGNESIUM	CVS Pharmacy	dcaaf24a-0fb9-41b9-881a-00fa60796ca9	2024-08-06	Warnings	Exact identifier application applno (ANDA): 207193 application number: ANDA207193 ndc (product): 69842-703
esomeprazole magnesium	ESOMEPRAZOLE MAGNESIUM	Meijer Distribution Inc	1dd30fec-15f4-44b2-a38f-e59ff4da206d	2024-08-06	Warnings	Exact identifier application applno (ANDA): 207193 application number: ANDA207193
DG Health Esomeprazole Magnesium	ESOMEPRAZOLE	Dolgencorp Inc	2b0e555d-3ed5-4ec4-82a6-855351c503b3	2024-08-02	Warnings	Exact identifier application applno (ANDA): 207193 application number: ANDA207193
dg health esomeprazole magnesium	ESOMEPRAZOLE	Dolgencorp, LLC	8f974698-ce9c-4ffb-b77e-9bad2c2ee2a1	2024-08-01	Warnings	Exact identifier application applno (ANDA): 207193 application number: ANDA207193
up and up esomeprazole magnesium	ESOMEPRAZOLE	Target Corporation	717e5d5b-4bf7-415e-b259-44056bc96d8b	2024-08-01	Warnings	Exact identifier application applno (ANDA): 207193 application number: ANDA207193
kirkland signature esomeprazole magnesium	ESOMEPRAZOLE	Costco Wholesale Company	4a87d5d5-c98b-4dc5-81be-50183342b047	2024-08-01	Warnings	Exact identifier application applno (ANDA): 207193 application number: ANDA207193 ndc (product): 63981-898
Good Neighbor Pharmacy Esomeprazole Magnesium	ESOMEPRAZOLE	Amerisource Bergen	b596055c-98b2-47b1-b174-ae7ad3ba97ee	2024-07-30	Warnings	Exact identifier application applno (ANDA): 207193 application number: ANDA207193
Exchange Select Esomeprazole Magnesium	ESOMEPRAZOLE	Army & Air Force Exchange Service	5fa9089f-90d1-48b6-bb79-c6171eeeaa03	2024-07-26	Warnings	Exact identifier application applno (ANDA): 207193 application number: ANDA207193
signature care esomeprazole magnesium	ESOMEPRAZOLE	Safeway	238b27e3-6993-4213-b7eb-062309398d1b	2024-07-26	Warnings	Exact identifier application applno (ANDA): 207193 application number: ANDA207193
good sense esomeprazole magnesium	ESOMEPRAZOLE	L. Perrigo Company	e54f2cc9-1d5f-4f0a-8bcf-bd5b917d98ec	2024-07-26	Warnings	Exact identifier application applno (ANDA): 207193 application number: ANDA207193
signature care esomeprazole magnesium	ESOMEPRAZOLE	Safeway	972bb479-7146-454d-ace4-f9314f0e584e	2024-07-26	Warnings	Exact identifier application applno (ANDA): 207193 application number: ANDA207193
basic care esomeprazole magnesium	ESOMEPRAZOLE	Amazon.com Services LLC	0b115351-318c-4bd9-935c-704a09bcdf52	2024-07-25	Warnings	Exact identifier application applno (ANDA): 207193 application number: ANDA207193 ndc (product): 72288-700
esomeprazole magnesium	ESOMEPRAZOLE	Kroger Company	da02c079-ed18-4896-896d-0489c8f43554	2024-07-25	Warnings	Exact identifier application applno (ANDA): 207193 application number: ANDA207193
esomeprazole magnesium	ESOMEPRAZOLE	Meijer Distribution Inc	126c269b-260d-40f4-879d-169c09251c67	2024-07-25	Warnings	Exact identifier application applno (ANDA): 207193 application number: ANDA207193
dg health esomeprazole magnesium	ESOMEPRAZOLE	Dolgencorp Inc	d5a842f3-d21b-4ddf-87f1-e44daf5cfe05	2024-05-08	Warnings	Exact identifier application applno (ANDA): 207193 application number: ANDA207193
esomeprazole magnesium	ESOMEPRAZOLE	Meijer, Inc.	8799c88f-dafb-4be6-b279-a54d916162fe	2024-03-25	Warnings	Exact identifier application applno (ANDA): 207193 application number: ANDA207193

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 · 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