For neurologic conditions associated with problem drooling. ANDA 216084, held by Msn. Glycopyrrolate.
As of Nov 15, 2026, ANDA 216084 (Glycopyrrolate), held by Msn, was first approved by FDA on Apr 8, 2025, 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 |
|---|---|---|---|
| Apr 8, 2025 | 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
