Treats peptic ulcer. ANDA 212696, held by Quagen. Glycopyrrolate.
As of Nov 15, 2026, ANDA 212696 (Glycopyrrolate), held by Quagen, was first approved by FDA on Jul 10, 2024, with 0 approved supplements and 0 published complete response letters.
Glycopyrrolate tablets are indicated in adults to reduce symptoms of a peptic ulcer as an adjunct to treatment of peptic ulcer. Limitations of Use Glycopyrrolate tablets are not indicated as monotherapy for the treatment of peptic ulcer because effectiveness in peptic ulcer healing has not been established.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 10, 2024 | Original application | Approved | None posted |
| Glycopyrrolate1MG · tablet;oral | Glycopyrrolate | Rx |
| Glycopyrrolate2MG · tablet;oral | Glycopyrrolate | Rx |
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
