ANDA 40568, held by Chartwell Rx. Glycopyrrolate.
As of Nov 15, 2026, ANDA 40568 (Glycopyrrolate), held by Chartwell Rx, was first approved by FDA on Dec 22, 2004, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 22, 2004 | Original application | Approved | None posted |
| Glycopyrrolate1MG · tablet;oral | Glycopyrrolate | Discontinued |
| Glycopyrrolate2MG · tablet;oral | Glycopyrrolate | Discontinued |
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
