Home Applications 021850 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 44 .
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 3 of 3 · 88 observed 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 2022-10-28 04:53 UTC 2022-10 N021850-001 ZEGERID 700MG;20MG;600MG TABLET, CHEWABLE / ORAL 2006-03-24 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 N021850-002 ZEGERID 700MG;40MG;600MG TABLET, CHEWABLE / ORAL 2006-03-24 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N021850-001 ZEGERID 700MG;20MG;600MG TABLET, CHEWABLE / ORAL 2006-03-24 e64feba35796…2022-09-29 23:25 UTC 2022-09 N021850-002 ZEGERID 700MG;40MG;600MG TABLET, CHEWABLE / ORAL 2006-03-24 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N021850-001 ZEGERID 700MG;20MG;600MG TABLET, CHEWABLE / ORAL 2006-03-24 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N021850-002 ZEGERID 700MG;40MG;600MG TABLET, CHEWABLE / ORAL 2006-03-24 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N021850-001 ZEGERID 700MG;20MG;600MG TABLET, CHEWABLE / ORAL 2006-03-24 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N021850-002 ZEGERID 700MG;40MG;600MG TABLET, CHEWABLE / ORAL 2006-03-24 a50c72e98297…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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