Application 202342

Type: NDA
Sponsor: BELCHER

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ESOMEPRAZOLE STRONTIUM	ESOMEPRAZOLE STRONTIUM	CAPSULE, DELAYED RELEASE;ORAL	24.65MG	Yes	No
002	ESOMEPRAZOLE STRONTIUM	ESOMEPRAZOLE STRONTIUM	CAPSULE, DELAYED RELEASE;ORAL	49.3MG	Yes	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
N202342-001	ESOMEPRAZOLE STRONTIUM	ESOMEPRAZOLE STRONTIUM	24.65MG	CAPSULE, DELAYED RELEASE / ORAL		RLD	2013-08-06
N202342-002	ESOMEPRAZOLE STRONTIUM	ESOMEPRAZOLE STRONTIUM	49.3MG	CAPSULE, DELAYED RELEASE / ORAL		RLD	2013-08-06

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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N202342-001	ESOMEPRAZOLE STRONTIUM	24.65MG	CAPSULE, DELAYED RELEASE / ORAL	RLD	2013-08-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202342-002	ESOMEPRAZOLE STRONTIUM	49.3MG	CAPSULE, DELAYED RELEASE / ORAL	RLD	2013-08-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N202342-001	ESOMEPRAZOLE STRONTIUM	24.65MG	CAPSULE, DELAYED RELEASE / ORAL	RLD	2013-08-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202342-002	ESOMEPRAZOLE STRONTIUM	49.3MG	CAPSULE, DELAYED RELEASE / ORAL	RLD	2013-08-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202342-001	ESOMEPRAZOLE STRONTIUM	24.65MG	CAPSULE, DELAYED RELEASE / ORAL	RLD	2013-08-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202342-002	ESOMEPRAZOLE STRONTIUM	49.3MG	CAPSULE, DELAYED RELEASE / ORAL	RLD	2013-08-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N202342-001	ESOMEPRAZOLE STRONTIUM	24.65MG	CAPSULE, DELAYED RELEASE / ORAL	RLD	2013-08-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202342-002	ESOMEPRAZOLE STRONTIUM	49.3MG	CAPSULE, DELAYED RELEASE / ORAL	RLD	2013-08-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202342-001	ESOMEPRAZOLE STRONTIUM	24.65MG	CAPSULE, DELAYED RELEASE / ORAL	RLD	2013-08-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202342-002	ESOMEPRAZOLE STRONTIUM	49.3MG	CAPSULE, DELAYED RELEASE / ORAL	RLD	2013-08-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202342-001	ESOMEPRAZOLE STRONTIUM	24.65MG	CAPSULE, DELAYED RELEASE / ORAL	RLD	2013-08-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202342-002	ESOMEPRAZOLE STRONTIUM	49.3MG	CAPSULE, DELAYED RELEASE / ORAL	RLD	2013-08-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202342-001	ESOMEPRAZOLE STRONTIUM	24.65MG	CAPSULE, DELAYED RELEASE / ORAL	RLD	2013-08-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202342-002	ESOMEPRAZOLE STRONTIUM	49.3MG	CAPSULE, DELAYED RELEASE / ORAL	RLD	2013-08-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202342-001	ESOMEPRAZOLE STRONTIUM	24.65MG	CAPSULE, DELAYED RELEASE / ORAL	RLD	2013-08-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202342-002	ESOMEPRAZOLE STRONTIUM	49.3MG	CAPSULE, DELAYED RELEASE / ORAL	RLD	2013-08-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202342-001	ESOMEPRAZOLE STRONTIUM	24.65MG	CAPSULE, DELAYED RELEASE / ORAL	RLD	2013-08-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202342-002	ESOMEPRAZOLE STRONTIUM	49.3MG	CAPSULE, DELAYED RELEASE / ORAL	RLD	2013-08-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202342-001	ESOMEPRAZOLE STRONTIUM	24.65MG	CAPSULE, DELAYED RELEASE / ORAL	RLD	2013-08-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202342-002	ESOMEPRAZOLE STRONTIUM	49.3MG	CAPSULE, DELAYED RELEASE / ORAL	RLD	2013-08-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N202342-001	ESOMEPRAZOLE STRONTIUM	24.65MG	CAPSULE, DELAYED RELEASE / ORAL	RLD	2013-08-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N202342-002	ESOMEPRAZOLE STRONTIUM	49.3MG	CAPSULE, DELAYED RELEASE / ORAL	RLD	2013-08-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202342-001	ESOMEPRAZOLE STRONTIUM	24.65MG	CAPSULE, DELAYED RELEASE / ORAL	RLD	2013-08-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202342-002	ESOMEPRAZOLE STRONTIUM	49.3MG	CAPSULE, DELAYED RELEASE / ORAL	RLD	2013-08-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N202342-001	ESOMEPRAZOLE STRONTIUM	24.65MG	CAPSULE, DELAYED RELEASE / ORAL	RLD	2013-08-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N202342-002	ESOMEPRAZOLE STRONTIUM	49.3MG	CAPSULE, DELAYED RELEASE / ORAL	RLD	2013-08-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N202342-001	ESOMEPRAZOLE STRONTIUM	24.65MG	CAPSULE, DELAYED RELEASE / ORAL	RLD	2013-08-06	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N202342-002	ESOMEPRAZOLE STRONTIUM	49.3MG	CAPSULE, DELAYED RELEASE / ORAL	RLD	2013-08-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N202342-001	ESOMEPRAZOLE STRONTIUM	24.65MG	CAPSULE, DELAYED RELEASE / ORAL	RLD	2013-08-06	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N202342-002	ESOMEPRAZOLE STRONTIUM	49.3MG	CAPSULE, DELAYED RELEASE / ORAL	RLD	2013-08-06	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N202342-001	ESOMEPRAZOLE STRONTIUM	24.65MG	CAPSULE, DELAYED RELEASE / ORAL	RLD	2013-08-06	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N202342-002	ESOMEPRAZOLE STRONTIUM	49.3MG	CAPSULE, DELAYED RELEASE / ORAL	RLD	2013-08-06	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N202342-001	ESOMEPRAZOLE STRONTIUM	24.65MG	CAPSULE, DELAYED RELEASE / ORAL	RLD	2013-08-06	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N202342-002	ESOMEPRAZOLE STRONTIUM	49.3MG	CAPSULE, DELAYED RELEASE / ORAL	RLD	2013-08-06	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N202342-001	ESOMEPRAZOLE STRONTIUM	24.65MG	CAPSULE, DELAYED RELEASE / ORAL	RLD	2013-08-06	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N202342-002	ESOMEPRAZOLE STRONTIUM	49.3MG	CAPSULE, DELAYED RELEASE / ORAL	RLD	2013-08-06	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N202342-001	ESOMEPRAZOLE STRONTIUM	24.65MG	CAPSULE, DELAYED RELEASE / ORAL	RLD	2013-08-06	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N202342-002	ESOMEPRAZOLE STRONTIUM	49.3MG	CAPSULE, DELAYED RELEASE / ORAL	RLD	2013-08-06	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N202342-001	ESOMEPRAZOLE STRONTIUM	24.65MG	CAPSULE, DELAYED RELEASE / ORAL	RLD	2013-08-06	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N202342-002	ESOMEPRAZOLE STRONTIUM	49.3MG	CAPSULE, DELAYED RELEASE / ORAL	RLD	2013-08-06	`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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ESOMEPRAZOLE STRONTIUM	ESOMEPRAZOLE STRONTIUM	R2 Pharma, LLC	3c916d32-f9e9-1d15-e054-00144ff88e88	2016-09-22	Warnings, Adverse reactions	Exact identifier application applno (NDA): 202342 application number: NDA202342 ndc (product): 70849-400 ndc (product): 70849-200

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
52246-400	ESOMEPRAZOLE STRONTIUM	esomeprazole strontium	ParaPRO LLC	NDA	Current
53746-955	Esomeprazole strontium	Esomeprazole strontium	Amneal Pharmaceuticals of New York LLC	NDA	Current
53746-955	Esomeprazole strontium	Esomeprazole strontium	Amneal Pharmaceuticals of New York LLC	NDA	Current
53746-955	Esomeprazole strontium	Esomeprazole strontium	Amneal Pharmaceuticals, LLC	NDA	Current
53746-957	Esomeprazole strontium	Esomeprazole strontium	Amneal Pharmaceuticals of New York LLC	NDA	Current
53746-957	Esomeprazole strontium	Esomeprazole strontium	Amneal Pharmaceuticals of New York LLC	NDA	Current
53746-957	Esomeprazole strontium	Esomeprazole strontium	Amneal Pharmaceuticals, LLC	NDA	Current
65162-955	Esomeprazole strontium	Esomeprazole strontium	Amneal Pharmaceuticals LLC	NDA AUTHORIZED GENERIC	Current
65162-955	Esomeprazole strontium	Esomeprazole strontium	Amneal Pharmaceuticals LLC	NDA AUTHORIZED GENERIC	Current
65162-955	Esomeprazole strontium	Esomeprazole strontium	Amneal Pharmaceuticals LLC	NDA AUTHORIZED GENERIC	Current
65162-955	Esomeprazole strontium	Esomeprazole strontium	Amneal Pharmaceuticals of New York, LLC	NDA	Current
65162-955	Esomeprazole strontium	Esomeprazole strontium	Amneal Pharmaceuticals LLC	NDA	Current
65162-957	Esomeprazole strontium	Esomeprazole strontium	Amneal Pharmaceuticals LLC	NDA AUTHORIZED GENERIC	Current
65162-957	Esomeprazole strontium	Esomeprazole strontium	Amneal Pharmaceuticals LLC	NDA AUTHORIZED GENERIC	Current
65162-957	Esomeprazole strontium	Esomeprazole strontium	Amneal Pharmaceuticals LLC	NDA AUTHORIZED GENERIC	Current
65162-957	Esomeprazole strontium	Esomeprazole strontium	Amneal Pharmaceuticals of New York, LLC	NDA	Current
65162-957	Esomeprazole strontium	Esomeprazole strontium	Amneal Pharmaceuticals LLC	NDA	Current
69336-129	Esomeprazole strontium	Esomeprazole strontium	Sterling-Knight Pharmaceuticals, LLC	NDA AUTHORIZED GENERIC	Current
70849-200	ESOMEPRAZOLE STRONTIUM	esomeprazole strontium	R2 Pharma, LLC	NDA	Current
70849-400	ESOMEPRAZOLE STRONTIUM	esomeprazole strontium	R2 Pharma, LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
70490	SUPPL	2022-03-11
70489	SUPPL	2022-03-11
70431	SUPPL	2022-03-07
65428	SUPPL	2020-12-01
65394	SUPPL	2020-11-30
65393	SUPPL	2020-11-30
54585	SUPPL	2018-06-14
54534	SUPPL	2018-06-12
54533	SUPPL	2018-06-12
52256	SUPPL	2018-02-01
45645	SUPPL	2016-10-26
19324	SUPPL	2014-12-29
32237	SUPPL	2014-12-23
43396	ORIG	2013-11-13
19323	ORIG	2013-08-09
10028	ORIG	2013-08-08
10029	ORIG	2013-05-01