FDA — authorised 30 January 2015
- Application: ANDA078830
- Marketing authorisation holder: PADAGIS US
- Local brand name: SCOPOLAMINE
- Indication: SYSTEM — TRANSDERMAL
- Status: approved
🇺🇸 SCOPOLAMINE in United States
FDA authorised SCOPOLAMINE on 30 January 2015 · 3,472 US adverse-event reports
Marketing authorisations
FDA — authorised 19 June 2019
- Application: ANDA203753
- Marketing authorisation holder: MYLAN TECHNOLOGIES
- Local brand name: SCOPOLAMINE
- Indication: SYSTEM — TRANSDERMAL
- Status: approved
FDA — authorised 24 November 2020
- Application: ANDA212342
- Marketing authorisation holder: RICONPHARMA LLC
- Status: supplemented
FDA — authorised 10 January 2022
- Application: ANDA208769
- Marketing authorisation holder: ACTAVIS LABS UT INC
- Status: approved
FDA — authorised 6 May 2024
- Application: ANDA215329
- Marketing authorisation holder: RHODES PHARMS
- Local brand name: SCOPOLAMINE
- Indication: SYSTEM — TRANSDERMAL
- Status: approved
FDA — authorised 29 August 2024
- Application: ANDA217893
- Marketing authorisation holder: ZYDUS PHARMS
- Local brand name: SCOPOLAMINE
- Indication: SYSTEM — TRANSDERMAL
- Status: approved
FDA — authorised 9 June 2025
- Application: ANDA218384
- Marketing authorisation holder: AMNEAL
- Local brand name: SCOPOLAMINE
- Indication: SYSTEM — TRANSDERMAL
- Status: approved
FDA
- Status: approved
Safety signals — FAERS
Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.
- Window: 20 April 2025 – 20 April 2026
- Total reports: 3,472
Most-reported reactions
- Off Label Use — 563 reports (16.22%)
- Nausea — 551 reports (15.87%)
- Vomiting — 405 reports (11.66%)
- Headache — 357 reports (10.28%)
- Drug Ineffective — 302 reports (8.7%)
- Death — 292 reports (8.41%)
- Dizziness — 276 reports (7.95%)
- Diarrhoea — 255 reports (7.34%)
- Product Adhesion Issue — 240 reports (6.91%)
- Fatigue — 231 reports (6.65%)
SCOPOLAMINE in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Neuroscience approved in United States
Frequently asked questions
Is SCOPOLAMINE approved in United States?
Yes. FDA authorised it on 30 January 2015; FDA authorised it on 19 June 2019; FDA authorised it on 24 November 2020.
Who is the marketing authorisation holder for SCOPOLAMINE in United States?
PADAGIS US holds the US marketing authorisation.