FDA — authorised 20 December 1985
- Application: NDA018654
- Marketing authorisation holder: HLR
- Local brand name: VERSED
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 Versed in United States
FDA authorised Versed on 20 December 1985
Marketing authorisations
FDA — authorised 27 April 2017
- Application: ANDA090316
- Marketing authorisation holder: ONESOURCE SPECIALTY
- Indication: Labeling
- Status: approved
FDA — authorised 17 May 2019
- Application: NDA211321
- Marketing authorisation holder: UCB INC
- Local brand name: NAYZILAM
- Indication: SPRAY — NASAL
- Status: approved
FDA — authorised 13 January 2023
- Application: NDA211844
- Marketing authorisation holder: INFORLIFE
- Indication: Labeling
- Status: approved
FDA — authorised 17 January 2023
- Application: ANDA090315
- Marketing authorisation holder: ONESOURCE SPECIALTY
- Indication: Labeling
- Status: approved
FDA — authorised 17 April 2023
- Application: ANDA216159
- Marketing authorisation holder: HIKMA
- Local brand name: MIDAZOLAM IN 0.9% SODIUM CHLORIDE
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 12 August 2024
- Application: ANDA218993
- Marketing authorisation holder: GLAND
- Status: approved
FDA — authorised 1 May 2025
- Application: ANDA218454
- Marketing authorisation holder: B BRAUN MEDICAL
- Status: approved
FDA
- Application: ANDA216048
- Marketing authorisation holder: CIPLA LTD
- Local brand name: MIDAZOLAM
- Indication: SPRAY — NASAL
- Status: approved
Versed 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 Versed approved in United States?
Yes. FDA authorised it on 20 December 1985; FDA authorised it on 27 April 2017; FDA authorised it on 17 May 2019.
Who is the marketing authorisation holder for Versed in United States?
HLR holds the US marketing authorisation.