Treats peptic ulcer. ANDA 40847, held by Chartwell Rx. Glycopyrrolate.
As of Nov 15, 2026, ANDA 40847 (Glycopyrrolate), held by Chartwell Rx, was first approved by FDA on Mar 21, 2008, with 2 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 21, 2008 | Original application | Approved | None posted |
| Glycopyrrolate1MG · tablet;oral | Glycopyrrolate | Rx |
| Glycopyrrolate2MG · tablet;oral | Glycopyrrolate | Rx |
| Jan 19, 2026 | Supplement 5Labeling · Standard review | Approved | None posted |
| Dec 6, 2012 | Supplement 1Labeling · Standard review | Approved | None posted |
| Mar 21, 2008 | Original application | Approved | None posted |
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
