Home Applications 018685 Application 018685
Type NDA
Sponsor SANOFI AVENTIS US Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 GAVISCON ALUMINUM HYDROXIDE; MAGNESIUM TRISILICATE TABLET, CHEWABLE;ORAL 80MG;20MG Yes No 002 GAVISCON ALUMINUM HYDROXIDE; MAGNESIUM TRISILICATE TABLET, CHEWABLE;ORAL 160MG;40MG Yes 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 N018685-001 GAVISCON ALUMINUM HYDROXIDE; MAGNESIUM TRISILICATE 80MG;20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET, CHEWABLE / ORAL RLD 1983-12-09 N018685-002 GAVISCON ALUMINUM HYDROXIDE; MAGNESIUM TRISILICATE 160MG;40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET, CHEWABLE / ORAL RLD 1983-12-09
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 2 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 2019-12-13 00:20 UTC 2019-12 N018685-001 GAVISCON 80MG;20MG TABLET, CHEWABLE / ORAL RLD 1983-12-09 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N018685-002 GAVISCON 160MG;40MG TABLET, CHEWABLE / ORAL RLD 1983-12-09 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N018685-001 GAVISCON 80MG;20MG TABLET, CHEWABLE / ORAL RLD 1983-12-09 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N018685-002 GAVISCON 160MG;40MG TABLET, CHEWABLE / ORAL RLD 1983-12-09 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N018685-001 GAVISCON 80MG;20MG TABLET, CHEWABLE / ORAL RLD 1983-12-09 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N018685-002 GAVISCON 160MG;40MG TABLET, CHEWABLE / ORAL RLD 1983-12-09 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N018685-001 GAVISCON 80MG;20MG TABLET, CHEWABLE / ORAL RLD 1983-12-09 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N018685-002 GAVISCON 160MG;40MG TABLET, CHEWABLE / ORAL RLD 1983-12-09 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N018685-001 GAVISCON 80MG;20MG TABLET, CHEWABLE / ORAL RLD 1983-12-09 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N018685-002 GAVISCON 160MG;40MG TABLET, CHEWABLE / ORAL RLD 1983-12-09 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N018685-001 GAVISCON 80MG;20MG TABLET, CHEWABLE / ORAL RLD 1983-12-09 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N018685-002 GAVISCON 160MG;40MG TABLET, CHEWABLE / ORAL RLD 1983-12-09 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N018685-001 GAVISCON 80MG;20MG TABLET, CHEWABLE / ORAL RLD 1983-12-09 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N018685-002 GAVISCON 160MG;40MG TABLET, CHEWABLE / ORAL RLD 1983-12-09 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N018685-001 GAVISCON 80MG;20MG TABLET, CHEWABLE / ORAL RLD 1983-12-09 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N018685-002 GAVISCON 160MG;40MG TABLET, CHEWABLE / ORAL RLD 1983-12-09 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N018685-001 GAVISCON 80MG;20MG TABLET, CHEWABLE / ORAL RLD 1983-12-09 b00525d2431f…2019-09-15 20:21 UTC 2019-09 N018685-002 GAVISCON 160MG;40MG TABLET, CHEWABLE / ORAL RLD 1983-12-09 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N018685-001 GAVISCON 80MG;20MG TABLET, CHEWABLE / ORAL RLD 1983-12-09 ea99ee380514…2019-07-19 19:46 UTC 2019-07 N018685-002 GAVISCON 160MG;40MG TABLET, CHEWABLE / ORAL RLD 1983-12-09 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N018685-001 GAVISCON 80MG;20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET, CHEWABLE / ORAL RLD 1983-12-09 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N018685-002 GAVISCON 160MG;40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET, CHEWABLE / ORAL RLD 1983-12-09 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N018685-001 GAVISCON 80MG;20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET, CHEWABLE / ORAL RLD 1983-12-09 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 N018685-002 GAVISCON 160MG;40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET, CHEWABLE / ORAL RLD 1983-12-09 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N018685-001 GAVISCON 80MG;20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET, CHEWABLE / ORAL RLD 1983-12-09 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 N018685-002 GAVISCON 160MG;40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET, CHEWABLE / ORAL RLD 1983-12-09 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N018685-001 GAVISCON 80MG;20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET, CHEWABLE / ORAL RLD 1983-12-09 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N018685-002 GAVISCON 160MG;40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET, CHEWABLE / ORAL RLD 1983-12-09 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N018685-001 GAVISCON 80MG;20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET, CHEWABLE / ORAL RLD 1983-12-09 9b2671bbb829…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N018685-002 GAVISCON 160MG;40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET, CHEWABLE / ORAL RLD 1983-12-09 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N018685-001 GAVISCON 80MG;20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET, CHEWABLE / ORAL RLD 1983-12-09 a67488948f0b…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N018685-002 GAVISCON 160MG;40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET, CHEWABLE / ORAL RLD 1983-12-09 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N018685-001 GAVISCON 80MG;20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET, CHEWABLE / ORAL RLD 1983-12-09 3f0d92c62455…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N018685-002 GAVISCON 160MG;40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET, CHEWABLE / ORAL RLD 1983-12-09 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N018685-001 GAVISCON 80MG;20MG TABLET, CHEWABLE / ORAL RLD 1983-12-09 053a50430f4f…2023-05-13 08:27 UTC 2023-05 N018685-002 GAVISCON 160MG;40MG TABLET, CHEWABLE / ORAL RLD 1983-12-09 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N018685-001 GAVISCON 80MG;20MG TABLET, CHEWABLE / ORAL RLD 1983-12-09 3bdfa0b2c4d7…2023-01-26 05:58 UTC 2023-01 N018685-002 GAVISCON 160MG;40MG TABLET, CHEWABLE / ORAL RLD 1983-12-09 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N018685-001 GAVISCON 80MG;20MG TABLET, CHEWABLE / ORAL RLD 1983-12-09 3a93d1ddd44b…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N018685-002 GAVISCON 160MG;40MG TABLET, CHEWABLE / ORAL RLD 1983-12-09 3a93d1ddd44b…
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 GAVISCON ALUMINUM HYDROXIDE AND MAGNESIUM CARBONATE Haleon US Holdings LLC 2d74e5bc-1f10-4fb6-9258-cd906e360013 2026-02-13 Warnings Name fallback brand name: GAVISCON
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 2 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0135-0096 Gaviscon aluminum hydroxide and magnesium trisilicate GlaxoSmithKline Consumer Healthcare Holdings (US) LLC NDA Current 0135-0096 Gaviscon aluminum hydroxide and magnesium trisilicate GlaxoSmithKline Consumer Healthcare Holdings (US) LLC NDA Current