FDA Approves TRANSDERM SCOP (NDA017874) Transdermal Scopolamine Patch

The U.S. Food and Drug Administration (FDA) has approved the prescription transdermal patch TRANSDERM SCOP (NDA 017874). The product is marketed by Baxter Healthcare Corporation and is classified as a human prescription drug. TRANSDERM SCOP delivers the anticholinergic agent scopolamine via a transdermal system. Each patch contains 1 mg of scopolamine designed to release over a 72‑hour period. The product is listed under the route "TRANSDERMAL" and the dosage form "SYSTEM". Regulatory filings show a series of approved submissions: a manufacturing (CMC) submission (submission 29) approved on 19 June 1998; an efficacy submission (submission 43) approved on 1 March 2019; labeling submissions approved in 2007 (submission 35), 2019 (submission 43), and most recently in 2024 (submission 51) with the latest label dated 12 June 2025. Relevant FDA documents are available via the FDA’s access portal. For full details, including labeling and approval letters, visit the FDA website.