For neurologic conditions associated with problem drooling. ANDA 204438, held by Ph Health. Glycopyrrolate.
As of Nov 15, 2026, ANDA 204438 (Glycopyrrolate), held by Ph Health, was first approved by FDA on Aug 9, 2021, 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 9, 2021 | 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
