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Dartisla ODT FDA Approval History

Last updated by Judith Stewart, BPharm on Dec 19, 2021.

FDA Approved: Yes (First approved December 16, 2021)
Brand name: Dartisla ODT
Generic name: glycopyrrolate
Dosage form: Orally Disintegrating Tablets
Company: Edenbridge Pharmaceuticals, LLC
Treatment for: Peptic Ulcer

Dartisla ODT (glycopyrrolate) is an anticholinergic indicated in adults to reduce symptoms of a peptic ulcer as an adjunct to treatment of peptic ulcer.

  • Glycopyrrolate works in the treatment of peptic ulcer by decreasing the volume and acidity of gastric secretions.
  • Dartisla ODT is administered two or three times daily at least one hour before or two hours after food. The orally disintegrating tablets are placed on top of the top of the tongue where they are allowed to disintegrate so they can be swallowed without water.
  • Adverse reactions include blurred vision, drowsiness, decreased sweating, flushing, vomiting, constipation, dry mouth, tachycardia, and urinary retention.



Development timeline for Dartisla ODT

Dec 17, 2021Approval FDA Approves Dartisla ODT (glycopyrrolate) for Use in the Treatment of Peptic Ulcer

Further information

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