FDA — authorised 4 June 1970
- Status: approved
🇺🇸 Inbrija in United States
FDA authorised Inbrija on 4 June 1970
Marketing authorisations
FDA — authorised 11 August 2000
- Application: ANDA075091
- Marketing authorisation holder: MYLAN
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 23 August 2007
- Application: ANDA077828
- Marketing authorisation holder: SUN PHARM INDS
- Status: approved
FDA — authorised 31 July 2009
- Application: ANDA078690
- Marketing authorisation holder: SUN PHARM
- Status: approved
FDA — authorised 8 February 2013
- Application: ANDA202323
- Marketing authorisation holder: ACCORD HLTHCARE
- Status: approved
FDA — authorised 19 November 2015
- Application: ANDA090324
- Marketing authorisation holder: PHARMOBEDIENT
- Indication: Labeling
- Status: approved
FDA — authorised 21 December 2018
- Application: NDA209184
- Marketing authorisation holder: MERZ
- Local brand name: INBRIJA
- Indication: POWDER — INHALATION
- Status: approved
Inbrija 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 Inbrija approved in United States?
Yes. FDA authorised it on 4 June 1970; FDA authorised it on 11 August 2000; FDA authorised it on 23 August 2007.
Who is the marketing authorisation holder for Inbrija in United States?
Merz is the originator. The local marketing authorisation holder may differ — check the official source linked above.