For neurologic conditions associated with problem drooling. ANDA 216368, held by Chartwell Rx. Glycopyrrolate.
As of Nov 15, 2026, ANDA 216368 (Glycopyrrolate), held by Chartwell Rx, was first approved by FDA on Aug 28, 2024, with 0 approved supplements and 0 published complete response letters.
Glycopyrrolate oral solution is indicated to reduce chronic severe drooling in patients aged 3 to 16 years with neurologic conditions associated with problem drooling (e.g., cerebral palsy).
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 28, 2024 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Glycopyrrolate1MG/5ML · solution;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
