FDA — authorised 30 January 2015
- Application: ANDA078830
- Marketing authorisation holder: PADAGIS US
- Local brand name: SCOPOLAMINE
- Indication: SYSTEM — TRANSDERMAL
- Status: approved
🇺🇸 DPI-386 Nasal Gel in United States
FDA authorised DPI-386 Nasal Gel on 30 January 2015
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 10 January 2022
- Application: ANDA208769
- Marketing authorisation holder: ACTAVIS LABS UT INC
- Local brand name: SCOPOLAMINE
- Indication: SYSTEM — TRANSDERMAL
- 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
Frequently asked questions
Is DPI-386 Nasal Gel approved in United States?
Yes. FDA authorised it on 30 January 2015; FDA authorised it on 19 June 2019; FDA authorised it on 10 January 2022.
Who is the marketing authorisation holder for DPI-386 Nasal Gel in United States?
PADAGIS US holds the US marketing authorisation.