ANDA 218384, held by Amneal. Scopolamine.
As of Nov 13, 2026, ANDA 218384 (Scopolamine), held by Amneal, was first approved by FDA on Jun 9, 2025, with 0 approved supplements and 0 published complete response letters.
Scopolamine transdermal system is indicated in adults for the prevention of: nausea and vomiting associated with motion sickness. post-operative nausea and vomiting (PONV) associated with recovery from anesthesia and/or opiate analgesia and surgery.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 9, 2025 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Scopolamine1MG/72HR · system;transdermal | Scopolamine | 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
