Application 207265

Type: ANDA
Sponsor: HEC PHARM

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM	CAPSULE, DELAYED REL PELLETS;ORAL	EQ 40MG BASE	No	No
002	ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM	CAPSULE, DELAYED REL PELLETS;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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A207265-001	ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL			2018-05-18
A207265-002	ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL			2018-05-18

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 3 · 86 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	A207265-001	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	2018-05-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207265-002	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	2018-05-18	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A207265-001	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	2018-05-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207265-002	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	2018-05-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207265-001	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	2018-05-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207265-002	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	2018-05-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207265-001	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	2018-05-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207265-002	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	2018-05-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207265-001	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	2018-05-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207265-002	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	2018-05-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207265-001	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	2018-05-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207265-002	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	2018-05-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207265-001	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	2018-05-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207265-002	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	2018-05-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207265-001	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	2018-05-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207265-002	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	2018-05-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207265-001	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	2018-05-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207265-002	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	2018-05-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207265-001	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	2018-05-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207265-002	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	2018-05-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207265-001	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	2018-05-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207265-002	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	2018-05-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207265-001	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	2018-05-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207265-002	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	2018-05-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207265-001	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	2018-05-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207265-002	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	2018-05-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207265-001	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	2018-05-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207265-002	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	2018-05-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207265-001	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	2018-05-18	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207265-002	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	2018-05-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207265-001	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	2018-05-18	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A207265-002	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	2018-05-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207265-001	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	2018-05-18	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207265-002	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	2018-05-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207265-001	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	2018-05-18	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A207265-002	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	2018-05-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207265-001	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	2018-05-18	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A207265-002	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	2018-05-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207265-001	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	2018-05-18	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A207265-002	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	2018-05-18	`74a2ff9319b5…`

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 6 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	A-S Medication Solutions	42b8d3f5-d919-48dd-92e4-ed49488dd664	2024-10-21	Warnings, Adverse reactions	Name fallback brand name: Esomeprazole Magnesium generic name: ESOMEPRAZOLE MAGNESIUM
Esomeprazole magnesium	ESOMEPRAZOLE MAGNESIUM DELAYED RELEASE CAPSULES	Asclemed USA, Inc.	85a963c1-9c13-4eb7-826b-08d5a991fe28	2024-10-04	Warnings, Adverse reactions	Name fallback brand name: Esomeprazole magnesium
Esomeprazole magnesium	ESOMEPRAZOLE MAGNESIUM DELAYED RELEASE CAPSULES	Proficient Rx LP	ad05cdde-a9e9-4442-80c4-1b02f5ebf6b4	2024-10-01	Warnings, Adverse reactions	Name fallback brand name: Esomeprazole magnesium
esomeprazole magnesium	ESOMEPRAZOLE MAGNESIUM	Bryant Ranch Prepack	f99f95a2-60e4-4781-80a9-e5b12897dff1	2024-09-03	Warnings, Adverse reactions	Name fallback brand name: esomeprazole magnesium generic name: ESOMEPRAZOLE MAGNESIUM
topcare esomeprazole magnesium	ESOMEPRAZOLE MAGNESIUM	Topco Associates LLC	86384845-0bea-490b-b04a-5770ef88b639	2024-09-01	Warnings	Name fallback generic name: ESOMEPRAZOLE MAGNESIUM
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	Bryant Ranch Prepack	7778bf7c-52f7-44b3-ac2c-e5a25f6967b7	2024-08-23	Warnings, Adverse reactions	Name fallback brand name: Esomeprazole Magnesium generic name: ESOMEPRAZOLE MAGNESIUM
Esomeprazole magnesium	ESOMEPRAZOLE MAGNESIUM DELAYED RELEASE CAPSULES	Bryant Ranch Prepack	db8a346e-dba1-41bc-b122-a1de868ee91a	2024-08-23	Warnings, Adverse reactions	Name fallback brand name: Esomeprazole magnesium
Esomeprazole magnesium	ESOMEPRAZOLE MAGNESIUM	Bryant Ranch Prepack	192c63f0-25ac-410e-ae75-62e96cbf6f9d	2024-08-15	Warnings, Adverse reactions	Name fallback brand name: Esomeprazole magnesium generic name: ESOMEPRAZOLE MAGNESIUM
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	Bryant Ranch Prepack	61cc0020-aab8-42a3-b0a6-93062f382c87	2024-08-12	Warnings, Adverse reactions	Name fallback brand name: Esomeprazole Magnesium generic name: ESOMEPRAZOLE MAGNESIUM
esomeprazole magnesium	ESOMEPRAZOLE MAGNESIUM	Bryant Ranch Prepack	2f1b1a56-b6c4-4e30-a1f7-12701aa5a535	2024-08-08	Warnings, Adverse reactions	Name fallback brand name: esomeprazole magnesium generic name: ESOMEPRAZOLE MAGNESIUM
esomeprazole magnesium	ESOMEPRAZOLE MAGNESIUM	CVS Pharmacy	dcaaf24a-0fb9-41b9-881a-00fa60796ca9	2024-08-06	Warnings	Name fallback brand name: esomeprazole magnesium generic name: ESOMEPRAZOLE MAGNESIUM
esomeprazole magnesium	ESOMEPRAZOLE MAGNESIUM	Meijer Distribution Inc	1dd30fec-15f4-44b2-a38f-e59ff4da206d	2024-08-06	Warnings	Name fallback brand name: esomeprazole magnesium generic name: ESOMEPRAZOLE MAGNESIUM
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	Advanced Rx of Tennessee, LLC	1e92676a-6c59-796d-e063-6294a90aaab4	2024-07-31	Warnings, Adverse reactions	Name fallback brand name: Esomeprazole Magnesium generic name: ESOMEPRAZOLE MAGNESIUM
Esomeprazole Magnesium	ESOMEPRAZOLE	H E B	0d08dd06-8df6-43ff-9033-8eebd215bec1	2024-07-26	Warnings	Name fallback brand name: Esomeprazole Magnesium
esomeprazole magnesium	ESOMEPRAZOLE	Kroger Company	da02c079-ed18-4896-896d-0489c8f43554	2024-07-25	Warnings	Name fallback brand name: esomeprazole magnesium
esomeprazole magnesium	ESOMEPRAZOLE	Meijer Distribution Inc	126c269b-260d-40f4-879d-169c09251c67	2024-07-25	Warnings	Name fallback brand name: esomeprazole magnesium
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	Advanced Rx of Tennessee, LLC	1d8bd104-66d4-8c19-e063-6394a90a3cb6	2024-07-18	Warnings, Adverse reactions	Name fallback brand name: Esomeprazole Magnesium generic name: ESOMEPRAZOLE MAGNESIUM
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	Camber Pharmaceuticals, Inc.	c18067ba-26ba-40b4-a328-3011710be216	2024-07-12	Warnings, Adverse reactions	Name fallback brand name: Esomeprazole Magnesium generic name: ESOMEPRAZOLE MAGNESIUM
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	CVS Pharmacy, Inc.	1867185e-9c34-c8cc-e063-6394a90ab3b1	2024-07-09	Warnings	Name fallback brand name: Esomeprazole Magnesium generic name: ESOMEPRAZOLE MAGNESIUM
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	Bryant Ranch Prepack	009794ae-8199-4176-9dc6-4c5e752d845c	2024-07-09	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 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
48792-7842	esomeprazole magnesium	Esomeprazole magnesium	Sunshine Lake Pharma Co., Ltd.	ANDA	Current
48792-7843	esomeprazole magnesium	Esomeprazole magnesium	Sunshine Lake Pharma Co., Ltd.	ANDA	Current