Application 210559

Type: ANDA
Sponsor: INDCHEMIE HEALTH

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	0	ESOMEPRAZOLE MAGNESIUM	CAPSULE, DELAYED REL PELLETS;ORAL		No	No
002	ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM	CAPSULE, DELAYED REL PELLETS;ORAL	EQ 40MG 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
A210559-001	ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2021-02-26
A210559-002	ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2021-02-26

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A210559-001	AB
A210559-002	AB

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 · 72 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A210559-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2021-02-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A210559-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2021-02-26	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A210559-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2021-02-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210559-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2021-02-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210559-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2021-02-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210559-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2021-02-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210559-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2021-02-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210559-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2021-02-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210559-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2021-02-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210559-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2021-02-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210559-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2021-02-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210559-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2021-02-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210559-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2021-02-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210559-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2021-02-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210559-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2021-02-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210559-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2021-02-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210559-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2021-02-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210559-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2021-02-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210559-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2021-02-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210559-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2021-02-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210559-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2021-02-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210559-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2021-02-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210559-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2021-02-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210559-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2021-02-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210559-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2021-02-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210559-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2021-02-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210559-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2021-02-26	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210559-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2021-02-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210559-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2021-02-26	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210559-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2021-02-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210559-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2021-02-26	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A210559-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2021-02-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210559-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2021-02-26	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210559-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2021-02-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210559-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2021-02-26	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A210559-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2021-02-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210559-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2021-02-26	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A210559-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2021-02-26	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A210559-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2021-02-26	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A210559-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2021-02-26	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 72 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A210559-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A210559-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A210559-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210559-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210559-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210559-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210559-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210559-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210559-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210559-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210559-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210559-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210559-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210559-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210559-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210559-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210559-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210559-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210559-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210559-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210559-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210559-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210559-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210559-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210559-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210559-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210559-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210559-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210559-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210559-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210559-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A210559-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210559-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210559-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210559-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A210559-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210559-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A210559-002	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A210559-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A210559-002	AB	1	`bb7c543d1eb4…`

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Esomeprazole magnesium	ESOMEPRAZOLE MAGNESIUM DELAYED RELEASE CAPSULES	Ascend Laboratories, LLC	277ce748-2809-4be0-81e7-6a4d604f2c6f	2025-06-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210559 application number: ANDA210559 ndc (product): 67877-571 ndc (product): 67877-572
Esomeprazole magnesium	ESOMEPRAZOLE MAGNESIUM DELAYED RELEASE CAPSULES	Asclemed USA, Inc.	85a963c1-9c13-4eb7-826b-08d5a991fe28	2024-10-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210559 application number: ANDA210559 ndc (product): 76420-226 ndc (product): 76420-227
Esomeprazole magnesium	ESOMEPRAZOLE MAGNESIUM DELAYED RELEASE CAPSULES	Proficient Rx LP	ad05cdde-a9e9-4442-80c4-1b02f5ebf6b4	2024-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210559 application number: ANDA210559 ndc (product): 71205-706
Esomeprazole magnesium	ESOMEPRAZOLE MAGNESIUM DELAYED RELEASE CAPSULES	Bryant Ranch Prepack	db8a346e-dba1-41bc-b122-a1de868ee91a	2024-08-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210559 application number: ANDA210559

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50090-5777	Esomeprazole magnesium	Esomeprazole magnesium delayed release capsules	A-S Medication Solutions	ANDA	Current
67877-571	Esomeprazole magnesium	Esomeprazole magnesium delayed release capsules	Ascend Laboratories, LLC	ANDA	Current
67877-571	Esomeprazole magnesium	Esomeprazole magnesium delayed release capsules	Ascend Laboratories, LLC	ANDA	Current
67877-572	Esomeprazole magnesium	Esomeprazole magnesium delayed release capsules	Ascend Laboratories, LLC	ANDA	Current
67877-572	Esomeprazole magnesium	Esomeprazole magnesium delayed release capsules	Ascend Laboratories, LLC	ANDA	Current
71205-706	Esomeprazole magnesium	Esomeprazole magnesium delayed release capsules	Proficient Rx LP	ANDA	Current
76420-226	Esomeprazole magnesium	Esomeprazole magnesium delayed release capsules	Asclemed USA, Inc.	ANDA	Current
76420-227	Esomeprazole magnesium	Esomeprazole magnesium delayed release capsules	Asclemed USA, Inc.	ANDA	Current