FDA — authorised 15 September 2017
- Application: NDA204325
- Marketing authorisation holder: NEOS THERAPS INC
- Local brand name: ADZENYS ER
- Indication: SUSPENSION, EXTENDED RELEASE — ORAL
- Status: approved
🇺🇸 d-Amphetamine Transdermal Patch in United States
FDA authorised d-Amphetamine Transdermal Patch on 15 September 2017
Marketing authorisations
FDA — authorised 4 November 2021
- Application: NDA210526
- Marketing authorisation holder: TRIS PHARMA INC
- Local brand name: DYANAVEL XR 5
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA
- Application: ANDA220284
- Marketing authorisation holder: GRANULES PHARMACEUTICALS INC
- Local brand name: AMPHETAMINE
- Indication: TABLET, EXTENDED RELEASE
- Status: approved
Frequently asked questions
Is d-Amphetamine Transdermal Patch approved in United States?
Yes. FDA authorised it on 15 September 2017; FDA authorised it on 4 November 2021; FDA has authorised it.
Who is the marketing authorisation holder for d-Amphetamine Transdermal Patch in United States?
NEOS THERAPS INC holds the US marketing authorisation.