Home Applications 022456 Application 022456
Type NDA
Sponsor SANTARUS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 MAGNESIUM HYDROXIDE AND OMEPRAZOLE AND SODIUM BICARBONATE MAGNESIUM HYDROXIDE; OMEPRAZOLE; SODIUM BICARBONATE TABLET;ORAL 343MG;20MG;750MG No No 002 MAGNESIUM HYDROXIDE AND OMEPRAZOLE AND SODIUM BICARBONATE MAGNESIUM HYDROXIDE; OMEPRAZOLE; SODIUM BICARBONATE TABLET;ORAL 343MG;40MG;750MG 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 N022456-001 MAGNESIUM HYDROXIDE AND OMEPRAZOLE AND SODIUM BICARBONATE MAGNESIUM HYDROXIDE; OMEPRAZOLE; SODIUM BICARBONATE 343MG;20MG;750MG TABLET / ORAL 2009-12-04 N022456-002 MAGNESIUM HYDROXIDE AND OMEPRAZOLE AND SODIUM BICARBONATE MAGNESIUM HYDROXIDE; OMEPRAZOLE; SODIUM BICARBONATE 343MG;40MG;750MG TABLET / ORAL 2009-12-04
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 N022456-001 MAGNESIUM HYDROXIDE AND OMEPRAZOLE AND SODIUM BICARBONATE 343MG;20MG;750MG TABLET / ORAL 2009-12-04 a50c72e98297…2026-08-01 22:54:32 2026-06 N022456-002 MAGNESIUM HYDROXIDE AND OMEPRAZOLE AND SODIUM BICARBONATE 343MG;40MG;750MG TABLET / ORAL 2009-12-04 a50c72e98297…