FDA — authorised 31 December 1987
- Application: NDA019111
- Marketing authorisation holder: UCB INC
- Local brand name: TUSSIONEX PENNKINETIC
- Indication: SUSPENSION, EXTENDED RELEASE — ORAL
- Status: approved
🇺🇸 Tussionex Pennkinetic in United States
FDA authorised Tussionex Pennkinetic on 31 December 1987
Marketing authorisations
FDA — authorised 24 June 2011
- Application: ANDA040736
- Marketing authorisation holder: AMNEAL PHARMS NY
- Indication: Labeling
- Status: approved
FDA — authorised 18 September 2018
- Application: ANDA201013
- Marketing authorisation holder: AUROLIFE PHARMA LLC
- Indication: REMS
- Status: approved
FDA — authorised 21 September 2018
- Application: ANDA202991
- Marketing authorisation holder: RHODES PHARMS
- Indication: Labeling
- Status: approved
FDA — authorised 4 March 2021
- Application: ANDA040746
- Marketing authorisation holder: AMNEAL PHARMS NY
- Indication: Labeling
- Status: approved
FDA — authorised 4 March 2021
- Application: ANDA206484
- Marketing authorisation holder: UPSHER SMITH LABS
- Indication: Labeling
- Status: approved
Tussionex Pennkinetic 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 Tussionex Pennkinetic approved in United States?
Yes. FDA authorised it on 31 December 1987; FDA authorised it on 24 June 2011; FDA authorised it on 18 September 2018.
Who is the marketing authorisation holder for Tussionex Pennkinetic in United States?
UCB INC holds the US marketing authorisation.