FDA — authorised 13 October 1987
- Application: ANDA071591
- Marketing authorisation holder: CHARTWELL RX
- Status: approved
🇺🇸 Ativan in United States
FDA authorised Ativan on 13 October 1987
Marketing authorisations
FDA — authorised 19 March 1996
- Application: NDA018140
- Marketing authorisation holder: HIKMA
- Indication: Labeling
- Status: approved
FDA — authorised 15 June 2010
- Application: ANDA090260
- Marketing authorisation holder: PHARM ASSOC
- Status: approved
FDA — authorised 18 November 2024
- Application: ANDA217598
- Marketing authorisation holder: FRESENIUS KABI USA
- Status: approved
FDA — authorised 24 July 2025
- Application: ANDA218597
- Marketing authorisation holder: GRAVITI PHARMS
- Status: approved
Ativan 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 Ativan approved in United States?
Yes. FDA authorised it on 13 October 1987; FDA authorised it on 19 March 1996; FDA authorised it on 15 June 2010.
Who is the marketing authorisation holder for Ativan in United States?
CHARTWELL RX holds the US marketing authorisation.