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 1.

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	N021850-001	ZEGERID	700MG;20MG;600MG	TABLET, CHEWABLE / ORAL			2006-03-24	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N021850-002	ZEGERID	700MG;40MG;600MG	TABLET, CHEWABLE / ORAL			2006-03-24	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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