Application 211977

Type: ANDA
Sponsor: HETERO LABS LTD III

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 20MG BASE	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 42.

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
A211977-001	ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2020-06-02
A211977-002	ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2020-06-02

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A211977-001	AB
A211977-002	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 · 76 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
2026-08-18 06:07:40	2026-07	A211977-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-06-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211977-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-06-02	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211977-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-06-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211977-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-06-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211977-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-06-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211977-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-06-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211977-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-06-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211977-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-06-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211977-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-06-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211977-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-06-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211977-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-06-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211977-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-06-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211977-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-06-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211977-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-06-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211977-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-06-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211977-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-06-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211977-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-06-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211977-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-06-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211977-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-06-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211977-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-06-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211977-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-06-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211977-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-06-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211977-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-06-02	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211977-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-06-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211977-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-06-02	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211977-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-06-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211977-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-06-02	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211977-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-06-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211977-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-06-02	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A211977-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-06-02	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211977-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-06-02	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211977-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-06-02	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211977-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-06-02	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A211977-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-06-02	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211977-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-06-02	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A211977-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-06-02	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A211977-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-06-02	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A211977-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-06-02	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211977-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-06-02	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A211977-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-06-02	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 76 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A211977-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211977-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211977-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211977-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211977-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211977-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211977-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211977-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211977-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211977-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211977-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211977-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211977-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211977-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211977-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211977-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211977-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211977-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211977-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211977-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211977-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211977-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211977-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211977-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211977-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211977-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211977-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211977-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211977-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A211977-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211977-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211977-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211977-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A211977-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211977-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A211977-002	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A211977-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A211977-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211977-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A211977-002	AB	1	`782e0a99824c…`

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 · 14 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	American Health Packaging	9a3df29e-dc44-4dfe-a26f-4bbbf18e31eb	2026-07-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211977 application number: ANDA211977
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	REMEDYREPACK INC.	ab3d31c8-cab1-4c44-bacd-5e5c67dd1384	2026-03-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211977 application number: ANDA211977
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	A-S Medication Solutions	27e7f7f0-7403-4425-8baa-d12ae9321364	2026-02-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211977 application number: ANDA211977
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	A-S Medication Solutions	00aa81c2-73c7-4bf8-94e9-f644381b631f	2026-01-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211977 application number: ANDA211977 ndc (product): 50090-6198
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	Asclemed USA, Inc.	2690dbe7-e559-4de8-9582-79b627af1964	2025-01-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211977 application number: ANDA211977
Esomeprazole DR	ESOMEPRAZOLE DR	Direct_Rx	e8937778-8baf-05f5-e053-2995a90a3a98	2025-01-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211977 application number: ANDA211977 ndc (product): 72189-381
ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM	Direct Rx	d5f56bd4-3a59-6857-e053-2995a90a6e00	2025-01-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211977 application number: ANDA211977 ndc (product): 72189-318
Esomeprazole Magnesium DR	ESOMEPRAZOLE MAGNESIUM	Advanced Rx Pharmacy of Tennessee, LLC	fab87a2d-79c8-6045-e053-6394a90a2368	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211977 application number: ANDA211977
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	A-S Medication Solutions	42b8d3f5-d919-48dd-92e4-ed49488dd664	2024-10-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211977 application number: ANDA211977
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	Bryant Ranch Prepack	7778bf7c-52f7-44b3-ac2c-e5a25f6967b7	2024-08-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211977 application number: ANDA211977 ndc (product): 71335-2018
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	Bryant Ranch Prepack	61cc0020-aab8-42a3-b0a6-93062f382c87	2024-08-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211977 application number: ANDA211977 ndc (product): 71335-2040
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	Advanced Rx of Tennessee, LLC	1e92676a-6c59-796d-e063-6294a90aaab4	2024-07-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211977 application number: ANDA211977
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	Advanced Rx of Tennessee, LLC	1d8bd104-66d4-8c19-e063-6394a90a3cb6	2024-07-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211977 application number: ANDA211977
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	Camber Pharmaceuticals, Inc.	c18067ba-26ba-40b4-a328-3011710be216	2024-07-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211977 application number: ANDA211977 ndc (product): 31722-664 ndc (product): 31722-665

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 13 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
31722-664	Esomeprazole Magnesium	Esomeprazole Magnesium	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-665	Esomeprazole Magnesium	Esomeprazole Magnesium	Camber Pharmaceuticals, Inc.	ANDA	Current
50090-6198	Esomeprazole Magnesium	Esomeprazole Magnesium	A-S Medication Solutions	ANDA	Current
68071-2590	Esomeprazole Magnesium	Esomeprazole Magnesium	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-2649	Esomeprazole Magnesium	Esomeprazole Magnesium	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-2782	Esomeprazole Magnesium	Esomeprazole Magnesium	NuCare Pharmaceuticals,Inc.	ANDA	Current
68788-8131	Esomeprazole Magnesium	Esomeprazole Magnesium	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-8160	Esomeprazole Magnesium	Esomeprazole Magnesium	Preferred Pharmaceuticals, Inc.	ANDA	Current
71335-2018	Esomeprazole Magnesium	Esomeprazole Magnesium	Bryant Ranch Prepack	ANDA	Current
71335-2040	Esomeprazole Magnesium	Esomeprazole Magnesium	Bryant Ranch Prepack	ANDA	Current
72189-318	ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM	Direct Rx	ANDA	Current
72189-318	ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM	Direct Rx	ANDA	Current
72189-381	Esomeprazole DR	Esomeprazole DR	Direct_Rx	ANDA	Current