FDA — authorised 9 May 2011
- Application: ANDA078413
- Marketing authorisation holder: AUROBINDO PHARMA
- Indication: Manufacturing (CMC)
- Status: approved
🇺🇸 Ambien in United States
FDA authorised Ambien on 9 May 2011
Marketing authorisations
FDA — authorised 10 August 2011
- Application: NDA021997
- Marketing authorisation holder: VIATRIS
- Indication: REMS
- Status: approved
FDA — authorised 19 March 2015
- Application: ANDA078970
- Marketing authorisation holder: LUPIN LTD
- Indication: Labeling
- Status: approved
FDA — authorised 15 November 2019
- Application: ANDA076410
- Marketing authorisation holder: TEVA
- Indication: Labeling
- Status: approved
FDA — authorised 2 July 2020
- Application: ANDA204229
- Marketing authorisation holder: PH HEALTH
- Indication: Labeling
- Status: approved
Ambien 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 Ambien approved in United States?
Yes. FDA authorised it on 9 May 2011; FDA authorised it on 10 August 2011; FDA authorised it on 19 March 2015.
Who is the marketing authorisation holder for Ambien in United States?
AUROBINDO PHARMA holds the US marketing authorisation.