Esomeprazole or its salts

Esomeprazole or its salts

For human use, including but not limited to esomeprazole magnesium, EXCEPT when sold for the 14-day treatment for frequent heartburn at a daily dose of 20 mg, in package sizes of no more than 280 mg of esomeprazole

Approval Date: November 13, 2018

Schedule: I

Footnote: