17 December 2021 - First and only orally disintegrating tablet of glycopyrrolate.
Edenbridge Pharmaceuticals today announced that it has received approval from the U.S. FDA on its 505(b)(2) new drug pplication for Dartisla ODT (glycopyrrolate) orally disintegrating tablets.
Dartilsa ODT is available in a 1.7 mg orally disintegrating tablet and is indicated for adults to reduce symptoms of a peptic ulcer as an adjunct to treatment of peptic ulcer.