Application 021850

Type: NDA
Sponsor: SANTARUS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ZEGERID	MAGNESIUM HYDROXIDE; OMEPRAZOLE; SODIUM BICARBONATE	TABLET, CHEWABLE;ORAL	700MG;20MG;600MG	No	No
002	ZEGERID	MAGNESIUM HYDROXIDE; OMEPRAZOLE; SODIUM BICARBONATE	TABLET, CHEWABLE;ORAL	700MG;40MG;600MG	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
N021850-001	ZEGERID	MAGNESIUM HYDROXIDE; OMEPRAZOLE; SODIUM BICARBONATE	700MG;20MG;600MG	TABLET, CHEWABLE / ORAL			2006-03-24
N021850-002	ZEGERID	MAGNESIUM HYDROXIDE; OMEPRAZOLE; SODIUM BICARBONATE	700MG;40MG;600MG	TABLET, CHEWABLE / ORAL			2006-03-24

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	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N021850-001	ZEGERID	700MG;20MG;600MG	TABLET, CHEWABLE / ORAL	2006-03-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021850-002	ZEGERID	700MG;40MG;600MG	TABLET, CHEWABLE / ORAL	2006-03-24	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021850-001	ZEGERID	700MG;20MG;600MG	TABLET, CHEWABLE / ORAL	2006-03-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021850-002	ZEGERID	700MG;40MG;600MG	TABLET, CHEWABLE / ORAL	2006-03-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021850-001	ZEGERID	700MG;20MG;600MG	TABLET, CHEWABLE / ORAL	2006-03-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021850-002	ZEGERID	700MG;40MG;600MG	TABLET, CHEWABLE / ORAL	2006-03-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021850-001	ZEGERID	700MG;20MG;600MG	TABLET, CHEWABLE / ORAL	2006-03-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021850-002	ZEGERID	700MG;40MG;600MG	TABLET, CHEWABLE / ORAL	2006-03-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021850-001	ZEGERID	700MG;20MG;600MG	TABLET, CHEWABLE / ORAL	2006-03-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021850-002	ZEGERID	700MG;40MG;600MG	TABLET, CHEWABLE / ORAL	2006-03-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021850-001	ZEGERID	700MG;20MG;600MG	TABLET, CHEWABLE / ORAL	2006-03-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021850-002	ZEGERID	700MG;40MG;600MG	TABLET, CHEWABLE / ORAL	2006-03-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021850-001	ZEGERID	700MG;20MG;600MG	TABLET, CHEWABLE / ORAL	2006-03-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021850-002	ZEGERID	700MG;40MG;600MG	TABLET, CHEWABLE / ORAL	2006-03-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021850-001	ZEGERID	700MG;20MG;600MG	TABLET, CHEWABLE / ORAL	2006-03-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021850-002	ZEGERID	700MG;40MG;600MG	TABLET, CHEWABLE / ORAL	2006-03-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021850-001	ZEGERID	700MG;20MG;600MG	TABLET, CHEWABLE / ORAL	2006-03-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021850-002	ZEGERID	700MG;40MG;600MG	TABLET, CHEWABLE / ORAL	2006-03-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021850-001	ZEGERID	700MG;20MG;600MG	TABLET, CHEWABLE / ORAL	2006-03-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021850-002	ZEGERID	700MG;40MG;600MG	TABLET, CHEWABLE / ORAL	2006-03-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021850-001	ZEGERID	700MG;20MG;600MG	TABLET, CHEWABLE / ORAL	2006-03-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021850-002	ZEGERID	700MG;40MG;600MG	TABLET, CHEWABLE / ORAL	2006-03-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021850-001	ZEGERID	700MG;20MG;600MG	TABLET, CHEWABLE / ORAL	2006-03-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021850-002	ZEGERID	700MG;40MG;600MG	TABLET, CHEWABLE / ORAL	2006-03-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021850-001	ZEGERID	700MG;20MG;600MG	TABLET, CHEWABLE / ORAL	2006-03-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021850-002	ZEGERID	700MG;40MG;600MG	TABLET, CHEWABLE / ORAL	2006-03-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021850-001	ZEGERID	700MG;20MG;600MG	TABLET, CHEWABLE / ORAL	2006-03-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021850-002	ZEGERID	700MG;40MG;600MG	TABLET, CHEWABLE / ORAL	2006-03-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021850-001	ZEGERID	700MG;20MG;600MG	TABLET, CHEWABLE / ORAL	2006-03-24	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021850-002	ZEGERID	700MG;40MG;600MG	TABLET, CHEWABLE / ORAL	2006-03-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021850-001	ZEGERID	700MG;20MG;600MG	TABLET, CHEWABLE / ORAL	2006-03-24	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021850-002	ZEGERID	700MG;40MG;600MG	TABLET, CHEWABLE / ORAL	2006-03-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021850-001	ZEGERID	700MG;20MG;600MG	TABLET, CHEWABLE / ORAL	2006-03-24	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021850-002	ZEGERID	700MG;40MG;600MG	TABLET, CHEWABLE / ORAL	2006-03-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021850-001	ZEGERID	700MG;20MG;600MG	TABLET, CHEWABLE / ORAL	2006-03-24	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021850-002	ZEGERID	700MG;40MG;600MG	TABLET, CHEWABLE / ORAL	2006-03-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021850-001	ZEGERID	700MG;20MG;600MG	TABLET, CHEWABLE / ORAL	2006-03-24	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021850-002	ZEGERID	700MG;40MG;600MG	TABLET, CHEWABLE / ORAL	2006-03-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021850-001	ZEGERID	700MG;20MG;600MG	TABLET, CHEWABLE / ORAL	2006-03-24	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021850-002	ZEGERID	700MG;40MG;600MG	TABLET, CHEWABLE / ORAL	2006-03-24	`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
ZEGERID	OMEPRAZOLE AND SODIUM BICARBONATE	Santarus, Inc..	cd6868b9-5824-442b-8d65-4db29ecb70a4	2023-07-19	Warnings, Adverse reactions	Name fallback brand name: ZEGERID

Documents#

Document, Submission type, Date table
Document	Submission type	Date
23680	ORIG	2011-12-20
16456	SUPPL	2010-09-10
28710	SUPPL	2010-09-08
6304	SUPPL	2010-01-29
37760	SUPPL	2010-01-24
21842	ORIG	2007-02-05
6303	ORIG	2006-04-05