ANDA 208769, held by Actavis Labs Ut Inc. Scopolamine.
As of Nov 13, 2026, ANDA 208769 (Scopolamine), held by Actavis Labs Ut Inc, was first approved by FDA on Jan 10, 2022, 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. Scopolamine transdermal system is an anticholinergic 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 |
|---|---|---|---|
| Jan 10, 2022 | 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
