Treats peptic ulcer. ANDA 207201, held by Appco. Glycopyrrolate.
As of Nov 15, 2026, ANDA 207201 (Glycopyrrolate), held by Appco, was first approved by FDA on Jan 3, 2017, with 1 approved supplement and 0 published complete response letters.
Glycopyrrolate is indicated in adults to reduce symptoms of a peptic ulcer as an adjunct to treatment of peptic ulcer. Limitations of Use Glycopyrrolate is not indicated as monotherapy for the treatment of peptic ulcer because effectiveness in peptic ulcer healing has not been established.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 3, 2017 | Original application | Approved |
| Glycopyrrolate1MG · tablet;oral | Glycopyrrolate | Rx |
| Glycopyrrolate2MG · tablet;oral | Glycopyrrolate | Rx |
| Jun 26, 2025 | Supplement 6Labeling · Standard review | Approved | None posted |
| Jan 3, 2017 | Original application | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
