For neurologic conditions associated with problem drooling. ANDA 219267, held by Ajenat Pharms. Glycopyrrolate.
As of Nov 15, 2026, ANDA 219267 (Glycopyrrolate), held by Ajenat Pharms, was first approved by FDA on Oct 27, 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 |
|---|---|---|---|
| Oct 27, 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
