FDA — authorised 13 August 1999
- Marketing authorisation holder: PFIZER
- Status: approved
🇺🇸 Sonata in United States
FDA authorised Sonata on 13 August 1999
Marketing authorisations
FDA — authorised 13 August 1999
- Application: NDA020859
- Marketing authorisation holder: PFIZER
- Local brand name: SONATA
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 6 June 2008
- Application: ANDA078829
- Marketing authorisation holder: AUROBINDO PHARMA
- Local brand name: ZALEPLON
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 11 March 2014
- Application: ANDA077237
- Marketing authorisation holder: HIKMA
- Indication: Labeling
- Status: approved
FDA — authorised 11 March 2014
- Application: ANDA090374
- Marketing authorisation holder: ORBION PHARMS
- Indication: Labeling
- Status: approved
FDA — authorised 3 October 2019
- Application: ANDA078989
- Marketing authorisation holder: UNICHEM
- Indication: Labeling
- Status: approved
Sonata 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 Sonata approved in United States?
Yes. FDA authorised it on 13 August 1999; FDA authorised it on 13 August 1999; FDA authorised it on 6 June 2008.
Who is the marketing authorisation holder for Sonata in United States?
PFIZER holds the US marketing authorisation.