FDA — authorised 21 October 2014
- Application: NDA022117
- Marketing authorisation holder: ABBVIE
- Indication: Labeling
- Status: approved
🇺🇸 ASENAPINE MALEATE in United States
FDA authorised ASENAPINE MALEATE on 21 October 2014
Marketing authorisations
FDA — authorised 10 December 2020
- Application: ANDA205960
- Marketing authorisation holder: BRECKENRIDGE
- Local brand name: ASENAPINE MALEATE
- Indication: TABLET — SUBLINGUAL
- Status: approved
FDA — authorised 10 December 2020
- Application: ANDA206098
- Marketing authorisation holder: ALEMBIC
- Local brand name: ASENAPINE MALEATE
- Indication: TABLET — SUBLINGUAL
- Status: approved
FDA — authorised 10 December 2020
- Application: ANDA206107
- Marketing authorisation holder: SIGMAPHARM LABS LLC
- Local brand name: ASENAPINE MALEATE
- Indication: TABLET — SUBLINGUAL
- Status: approved
ASENAPINE MALEATE in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is ASENAPINE MALEATE approved in United States?
Yes. FDA authorised it on 21 October 2014; FDA authorised it on 10 December 2020; FDA authorised it on 10 December 2020.
Who is the marketing authorisation holder for ASENAPINE MALEATE in United States?
ABBVIE holds the US marketing authorisation.