For neurologic conditions associated with problem drooling. ANDA 212467, held by Cohance Lifesciences. Glycopyrrolate.
As of Nov 15, 2026, ANDA 212467 (Glycopyrrolate), held by Cohance Lifesciences, was first approved by FDA on Jul 5, 2022, 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 |
|---|---|---|---|
| Jul 5, 2022 | Original application | Approved |
| 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
