FDA — authorised 20 August 2007
- Application: NDA020666
- Marketing authorisation holder: IMPAX LABS INC
- Indication: Labeling
- Status: approved
🇺🇸 Albenza in United States
FDA authorised Albenza on 20 August 2007
Marketing authorisations
FDA — authorised 20 May 2019
- Application: ANDA208094
- Marketing authorisation holder: ACTAVIS ELIZABETH
- Status: approved
FDA — authorised 22 January 2021
- Application: ANDA213435
- Marketing authorisation holder: MSN
- Status: approved
FDA — authorised 26 January 2021
- Application: ANDA211034
- Marketing authorisation holder: DR REDDYS
- Status: approved
FDA — authorised 4 September 2024
- Application: ANDA215652
- Marketing authorisation holder: ALEMBIC
- Status: approved
Albenza in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Infectious Disease approved in United States
Frequently asked questions
Is Albenza approved in United States?
Yes. FDA authorised it on 20 August 2007; FDA authorised it on 20 May 2019; FDA authorised it on 22 January 2021.
Who is the marketing authorisation holder for Albenza in United States?
IMPAX LABS INC holds the US marketing authorisation.