Application Nr Approved Date Route Status External Links
NDA022287 2009-01-30 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Dexilant Is A Proton Pump Inhibitor (ppi) Indicated In Patients 12 Years Of Age And Older For: Healing Of All Grades Of Erosive Esophagitis (ee). (1.1) Maintenance Of Healed Ee And Relief Of Heartburn. (1.2) Treatment Of Symptomatic Non-Erosive Gastroesophageal Reflux Disease (gerd). (1.3) 1.1 Healing Of Erosive Esophagitis Dexilant Is Indicated In Patients 12 Years Of Age And Older For Healing Of All Grades Of Erosive Esophagitis (ee) For Up To Eight Weeks. 1.2 Maintenance Of Healed Erosive Esophagitis And Relief Of Heartburn Dexilant Is Indicated In Patients 12 Years Of Age And Older To Maintain Healing Of Ee And Relief Of Heartburn For Up To Six Months In Adults And 16 Weeks In Patients 12 To 17 Years Of Age. 1.3 Treatment Of Symptomatic Non-Erosive Gastroesophageal Reflux Disease Dexilant Is Indicated In Patients 12 Years Of Age And Older For The Treatment Of Heartburn Associated With Symptomatic Non-Erosive Gastroesophageal Reflux Disease (gerd) For Four Weeks.

All Formulated Excipients (7 Total)

Name Structure Kind Function Status
1. Magnesium Carbonate MAGNESIUM CARBONATE Molecular B&N-Buffer & neutralizing agent FS-Substances permitted as optional ingredient in a standardized food.
2. Sucrose SUCROSE Molecular NUTRS-Nutritive Sweetener GRAS-Generally recognized as safe.
3. Titanium Dioxide TITANIUM DIOXIDE Unresolved DYE-Dye
4. Talc TALC Unresolved DYE-Dye GRAS-Generally recognized as safe.
5. Polyethylene Glycol 8000 POLYETHYLENE GLYCOL 8000 Unresolved
6. Triethyl Citrate TRIETHYL CITRATE Molecular MISC-Miscellaneous GRAS-Generally recognized as safe.
7. Polysorbate 80 POLYSORBATE 80 Unresolved AF-Antifoaming (or defoaming) agent , EMUL-Emulsifier , MISC-Miscellaneous , SDA-Solubilizing & dispersing agent REG-Food additives for which a petition has been filed and a regulation issued.

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Dexlansoprazole DEXLANSOPRAZOLE ZINC3830986

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