For neurologic conditions associated with problem drooling. ANDA 216297, held by Sciegen Pharms. Glycopyrrolate.
As of Nov 15, 2026, ANDA 216297 (Glycopyrrolate), held by Sciegen Pharms, was first approved by FDA on Oct 7, 2024, with 1 approved supplement and 0 published complete response letters.
Glycopyrrolate oral solution is indicated to reduce chronic severe drooling in patients aged 3 years to 16 years with neurologic conditions associated with problem drooling (e.g., cerebral palsy).
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 7, 2024 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Glycopyrrolate1MG/5ML · solution;oral | Glycopyrrolate | Rx |
| Jun 13, 2025 | Supplement 1Labeling · Standard review | Approved | None posted |
| Oct 7, 2024 | Original application | Approved | None posted |
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
