Treats peptic ulcer. ANDA 91522, held by Lgm Pharma. Glycopyrrolate.
As of Nov 15, 2026, ANDA 91522 (Glycopyrrolate), held by Lgm Pharma, was first approved by FDA on Mar 12, 2012, with 0 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE For use as adjunctive therapy in the treatment of peptic ulcer.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 12, 2012 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Glycopyrrolate1.5MG · 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
