Application 209735

Type: ANDA
Sponsor: SUN 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 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
A209735-001	ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2018-04-30
A209735-002	ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2018-04-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A209735-001	AB
A209735-002	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 3 · 84 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	A209735-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2018-04-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209735-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2018-04-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209735-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2018-04-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209735-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2018-04-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209735-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2018-04-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209735-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2018-04-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209735-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2018-04-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209735-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2018-04-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209735-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL		2018-04-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209735-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL		2018-04-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209735-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL		2018-04-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209735-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL		2018-04-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209735-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL		2018-04-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209735-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL		2018-04-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209735-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL		2018-04-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209735-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL		2018-04-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209735-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2018-04-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209735-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2018-04-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209735-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2018-04-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209735-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2018-04-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209735-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2018-04-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209735-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2018-04-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209735-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2018-04-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209735-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2018-04-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209735-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2018-04-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209735-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2018-04-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209735-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2018-04-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209735-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2018-04-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209735-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2018-04-30	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A209735-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2018-04-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209735-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2018-04-30	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209735-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2018-04-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209735-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2018-04-30	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A209735-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2018-04-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209735-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2018-04-30	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A209735-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2018-04-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209735-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2018-04-30	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A209735-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2018-04-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209735-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2018-04-30	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A209735-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2018-04-30	`bb7c543d1eb4…`

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	A209735-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209735-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209735-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209735-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209735-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209735-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209735-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209735-002	AB	1	`6a471c1ec25d…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209735-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209735-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209735-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209735-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209735-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209735-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209735-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209735-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209735-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209735-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209735-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209735-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209735-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A209735-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209735-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209735-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209735-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A209735-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209735-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A209735-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209735-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A209735-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209735-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A209735-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209735-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A209735-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209735-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209735-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209735-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A209735-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209735-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A209735-002	AB	1	`8869cabd3fbd…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Esomeprazole magnesium	ESOMEPRAZOLE MAGNESIUM	Golden State Medical Supply, Inc.	43cf2754-3ec7-75f7-e063-6394a90adfeb	2025-11-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209735 application number: ANDA209735
Esomeprazole magnesium	ESOMEPRAZOLE MAGNESIUM	Sun Pharmaceutical Industries, Inc	dc85d0c8-d3c4-4d37-9a5b-8f5f992bb3bf	2025-09-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209735 application number: ANDA209735 ndc (product): 63304-735 ndc (product): 63304-734

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 20 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50090-5365	Esomeprazole magnesium	Esomeprazole magnesium	A-S Medication Solutions	ANDA	Current
50090-5365	Esomeprazole magnesium	Esomeprazole magnesium	A-S Medication Solutions	ANDA	Current
50090-5552	Esomeprazole magnesium	Esomeprazole magnesium	A-S Medication Solutions	ANDA	Current
63304-734	Esomeprazole magnesium	Esomeprazole magnesium	Sun Pharmaceutical Industries, Inc	ANDA	Current
63304-734	Esomeprazole magnesium	Esomeprazole magnesium	Sun Pharmaceutical Industries, Inc	ANDA	Current
63304-734	Esomeprazole magnesium	Esomeprazole magnesium	Sun Pharmaceutical Industries, Inc	ANDA	Current
63304-734	Esomeprazole magnesium	Esomeprazole magnesium	Sun Pharmaceutical Industries, Inc	ANDA	Current
63304-735	Esomeprazole magnesium	Esomeprazole magnesium	Sun Pharmaceutical Industries, Inc	ANDA	Current
63304-735	Esomeprazole magnesium	Esomeprazole magnesium	Sun Pharmaceutical Industries, Inc	ANDA	Current
63304-735	Esomeprazole magnesium	Esomeprazole magnesium	Sun Pharmaceutical Industries, Inc	ANDA	Current
63304-735	Esomeprazole magnesium	Esomeprazole magnesium	Sun Pharmaceutical Industries, Inc	ANDA	Current
68071-2241	Esomeprazole magnesium	Esomeprazole magnesium	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-2241	Esomeprazole magnesium	Esomeprazole magnesium	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-5270	Esomeprazole magnesium	Esomeprazole magnesium	NuCare Pharmaceuticals,Inc.	ANDA	Current
71335-2011	Esomeprazole magnesium	Esomeprazole magnesium	Bryant Ranch Prepack	ANDA	Current
71335-2011	Esomeprazole magnesium	Esomeprazole magnesium	Bryant Ranch Prepack	ANDA	Current
71610-665	Esomeprazole magnesium	Esomeprazole magnesium	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
80425-0183	Esomeprazole Magnesium	Esomeprazole Magnesium	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0183	Esomeprazole Magnesium	Esomeprazole Magnesium	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0183	Esomeprazole Magnesium	Esomeprazole Magnesium	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current