FDA.reportPublic FDA data

Application 021850

Type
NDA
Sponsor
SANTARUS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ZEGERIDMAGNESIUM HYDROXIDE; OMEPRAZOLE; SODIUM BICARBONATETABLET, CHEWABLE;ORAL700MG;20MG;600MGNoNo
002ZEGERIDMAGNESIUM HYDROXIDE; OMEPRAZOLE; SODIUM BICARBONATETABLET, CHEWABLE;ORAL700MG;40MG;600MGNoNo

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021850-001ZEGERIDMAGNESIUM HYDROXIDE; OMEPRAZOLE; SODIUM BICARBONATE700MG;20MG;600MGTABLET, CHEWABLE / ORAL2006-03-24
N021850-002ZEGERIDMAGNESIUM HYDROXIDE; OMEPRAZOLE; SODIUM BICARBONATE700MG;40MG;600MGTABLET, CHEWABLE / ORAL2006-03-24

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N021850-001ZEGERID700MG;20MG;600MGTABLET, CHEWABLE / ORAL2006-03-2484e616aacf4f…
2026-09-14 22:38:342026-08N021850-002ZEGERID700MG;40MG;600MGTABLET, CHEWABLE / ORAL2006-03-2484e616aacf4f…
2026-08-18 06:07:402026-07N021850-001ZEGERID700MG;20MG;600MGTABLET, CHEWABLE / ORAL2006-03-24caaa826d4ba7…
2026-08-18 06:07:402026-07N021850-002ZEGERID700MG;40MG;600MGTABLET, CHEWABLE / ORAL2006-03-24caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N021850-001ZEGERID700MG;20MG;600MGTABLET, CHEWABLE / ORAL2006-03-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021850-002ZEGERID700MG;40MG;600MGTABLET, CHEWABLE / ORAL2006-03-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021850-001ZEGERID700MG;20MG;600MGTABLET, CHEWABLE / ORAL2006-03-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021850-002ZEGERID700MG;40MG;600MGTABLET, CHEWABLE / ORAL2006-03-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08N021850-001ZEGERID700MG;20MG;600MGTABLET, CHEWABLE / ORAL2006-03-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021850-002ZEGERID700MG;40MG;600MGTABLET, CHEWABLE / ORAL2006-03-246a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021850-001ZEGERID700MG;20MG;600MGTABLET, CHEWABLE / ORAL2006-03-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021850-002ZEGERID700MG;40MG;600MGTABLET, CHEWABLE / ORAL2006-03-24fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021850-001ZEGERID700MG;20MG;600MGTABLET, CHEWABLE / ORAL2006-03-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021850-002ZEGERID700MG;40MG;600MGTABLET, CHEWABLE / ORAL2006-03-24b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021850-001ZEGERID700MG;20MG;600MGTABLET, CHEWABLE / ORAL2006-03-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021850-002ZEGERID700MG;40MG;600MGTABLET, CHEWABLE / ORAL2006-03-2403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021850-001ZEGERID700MG;20MG;600MGTABLET, CHEWABLE / ORAL2006-03-242680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021850-002ZEGERID700MG;40MG;600MGTABLET, CHEWABLE / ORAL2006-03-242680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021850-001ZEGERID700MG;20MG;600MGTABLET, CHEWABLE / ORAL2006-03-245bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021850-002ZEGERID700MG;40MG;600MGTABLET, CHEWABLE / ORAL2006-03-245bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021850-001ZEGERID700MG;20MG;600MGTABLET, CHEWABLE / ORAL2006-03-24d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021850-002ZEGERID700MG;40MG;600MGTABLET, CHEWABLE / ORAL2006-03-24d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021850-001ZEGERID700MG;20MG;600MGTABLET, CHEWABLE / ORAL2006-03-24d06236e962d9…
2024-10-29 15:01 UTC2024-10N021850-002ZEGERID700MG;40MG;600MGTABLET, CHEWABLE / ORAL2006-03-24d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021850-001ZEGERID700MG;20MG;600MGTABLET, CHEWABLE / ORAL2006-03-2479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021850-002ZEGERID700MG;40MG;600MGTABLET, CHEWABLE / ORAL2006-03-2479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021850-001ZEGERID700MG;20MG;600MGTABLET, CHEWABLE / ORAL2006-03-24301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021850-002ZEGERID700MG;40MG;600MGTABLET, CHEWABLE / ORAL2006-03-24301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021850-001ZEGERID700MG;20MG;600MGTABLET, CHEWABLE / ORAL2006-03-241e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021850-002ZEGERID700MG;40MG;600MGTABLET, CHEWABLE / ORAL2006-03-241e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021850-001ZEGERID700MG;20MG;600MGTABLET, CHEWABLE / ORAL2006-03-248072bd15b7f6…
2024-05-31 18:47 UTC2024-05N021850-002ZEGERID700MG;40MG;600MGTABLET, CHEWABLE / ORAL2006-03-248072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021850-001ZEGERID700MG;20MG;600MGTABLET, CHEWABLE / ORAL2006-03-245c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021850-002ZEGERID700MG;40MG;600MGTABLET, CHEWABLE / ORAL2006-03-245c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021850-001ZEGERID700MG;20MG;600MGTABLET, CHEWABLE / ORAL2006-03-245d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021850-002ZEGERID700MG;40MG;600MGTABLET, CHEWABLE / ORAL2006-03-245d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021850-001ZEGERID700MG;20MG;600MGTABLET, CHEWABLE / ORAL2006-03-244b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021850-002ZEGERID700MG;40MG;600MGTABLET, CHEWABLE / ORAL2006-03-244b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021850-001ZEGERID700MG;20MG;600MGTABLET, CHEWABLE / ORAL2006-03-2474a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021850-002ZEGERID700MG;40MG;600MGTABLET, CHEWABLE / ORAL2006-03-2474a2ff9319b5…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
23680ORIG2011-12-20
16456SUPPL2010-09-10
28710SUPPL2010-09-08
6304SUPPL2010-01-29
37760SUPPL2010-01-24
21842ORIG2007-02-05
6303ORIG2006-04-05