Application 208333

Type: ANDA
Sponsor: ALKEM LABS LTD

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 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
A208333-001	ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2017-10-20
A208333-002	ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2017-10-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A208333-001	AB
A208333-002	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 · 86 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	A208333-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-10-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208333-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-10-20	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A208333-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-10-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208333-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-10-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208333-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-10-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208333-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-10-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208333-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-10-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208333-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-10-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208333-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-10-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208333-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-10-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208333-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-10-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208333-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-10-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208333-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-10-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208333-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-10-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208333-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-10-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208333-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-10-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208333-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-10-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208333-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-10-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208333-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-10-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208333-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-10-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208333-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-10-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208333-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-10-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208333-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-10-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208333-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-10-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208333-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-10-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208333-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-10-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208333-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-10-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208333-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-10-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208333-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-10-20	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208333-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-10-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208333-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-10-20	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A208333-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-10-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208333-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-10-20	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208333-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-10-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208333-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-10-20	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A208333-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-10-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208333-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-10-20	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A208333-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-10-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208333-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-10-20	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A208333-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-10-20	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 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	A208333-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208333-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A208333-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208333-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208333-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208333-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208333-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208333-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208333-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208333-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208333-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208333-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208333-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208333-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208333-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208333-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208333-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208333-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208333-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208333-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208333-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208333-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208333-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208333-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208333-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208333-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208333-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208333-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208333-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208333-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208333-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A208333-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208333-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208333-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208333-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A208333-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208333-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A208333-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208333-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A208333-002	AB	1	`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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Esomeprazole magnesium	ESOMEPRAZOLE MAGNESIUM	Ascend Laboratories, LLC	f3d4a0d7-77fd-496e-8dfa-2b2dbace4bac	2024-02-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208333 application number: ANDA208333 ndc (product): 67877-479 ndc (product): 67877-478

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 · 27 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
61919-789	ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM	DirectRX	ANDA	Current
61919-789	ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM	DirectRX	ANDA	Current
61919-868	ESOMEPRAZOLE MAGNEISUM D/R	ESOMEPRAZOLE MAGNEISUM D/R	Direct_Rx	ANDA	Current
67877-478	Esomeprazole magnesium	Esomeprazole magnesium	Ascend Laboratories, LLC	ANDA	Current
67877-478	Esomeprazole magnesium	Esomeprazole magnesium	Ascend Laboratories, LLC	ANDA	Current
67877-478	Esomeprazole magnesium	Esomeprazole magnesium	Ascend Laboratories, LLC	ANDA	Current
67877-479	Esomeprazole magnesium	Esomeprazole magnesium	Ascend Laboratories, LLC	ANDA	Current
67877-479	Esomeprazole magnesium	Esomeprazole magnesium	Ascend Laboratories, LLC	ANDA	Current
67877-479	Esomeprazole magnesium	Esomeprazole magnesium	Ascend Laboratories, LLC	ANDA	Current
68071-4886	Esomeprazole magnesium	Esomeprazole magnesium	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4886	Esomeprazole magnesium	Esomeprazole magnesium	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4888	Esomeprazole magnesium	Esomeprazole magnesium	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4888	Esomeprazole magnesium	Esomeprazole magnesium	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4936	Esomeprazole magnesium	Esomeprazole magnesium	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4936	Esomeprazole magnesium	Esomeprazole magnesium	NuCare Pharmaceuticals,Inc.	ANDA	Current
68788-7442	Esomeprazole magnesium	Esomeprazole magnesium	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-7442	Esomeprazole magnesium	Esomeprazole magnesium	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-7483	Esomeprazole magnesium	Esomeprazole magnesium	Preferred Pharmaceuticals Inc.	ANDA	Current
71335-0987	Esomeprazole magnesium	Esomeprazole magnesium	Bryant Ranch Prepack	ANDA	Current
71335-0987	Esomeprazole magnesium	Esomeprazole magnesium	Bryant Ranch Prepack	ANDA	Current
71335-0987	Esomeprazole magnesium	Esomeprazole magnesium	Bryant Ranch Prepack	ANDA	Current
71335-0987	Esomeprazole magnesium	Esomeprazole magnesium	Bryant Ranch Prepack	ANDA	Current
71335-0987	Esomeprazole magnesium	Esomeprazole magnesium	Bryant Ranch Prepack	ANDA	Current
71335-1148	Esomeprazole magnesium	Esomeprazole magnesium	Bryant Ranch Prepack	ANDA	Current
71335-1148	Esomeprazole magnesium	Esomeprazole magnesium	Bryant Ranch Prepack	ANDA	Current
71335-1148	Esomeprazole magnesium	Esomeprazole magnesium	Bryant Ranch Prepack	ANDA	Current
71335-1148	Esomeprazole magnesium	Esomeprazole magnesium	Bryant Ranch Prepack	ANDA	Current