FDA — authorised 20 June 2000
- Application: ANDA075484
- Marketing authorisation holder: HOSPIRA
- Local brand name: MIDAZOLAM HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 Versed in United States
FDA authorised Versed on 20 June 2000
Marketing authorisations
FDA — authorised 20 June 2000
- Application: ANDA075243
- Marketing authorisation holder: HIKMA
- Local brand name: MIDAZOLAM HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 20 June 2000
- Application: ANDA075154
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: MIDAZOLAM HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 20 June 2000
- Application: ANDA075293
- Marketing authorisation holder: HOSPIRA
- Local brand name: MIDAZOLAM HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 20 June 2000
- Application: ANDA075455
- Marketing authorisation holder: BEN VENUE
- Local brand name: MIDAZOLAM HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 23 June 2000
- Application: ANDA075247
- Marketing authorisation holder: HIKMA
- Local brand name: MIDAZOLAM HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 23 June 2000
- Application: ANDA075249
- Marketing authorisation holder: BEDFORD
- Local brand name: MIDAZOLAM HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 30 June 2000
- Application: ANDA075481
- Marketing authorisation holder: EPIC PHARMA LLC
- Local brand name: MIDAZOLAM HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 15 March 2002
- Application: ANDA076058
- Marketing authorisation holder: SUN PHARM INDS LTD
- Local brand name: MIDAZOLAM HYDROCHLORIDE
- Indication: SYRUP — ORAL
- Status: approved
FDA — authorised 30 April 2002
- Application: ANDA075873
- Marketing authorisation holder: HIKMA
- Local brand name: MIDAZOLAM HYDROCHLORIDE
- Indication: SYRUP — ORAL
- Status: approved
FDA — authorised 13 June 2002
- Application: ANDA075856
- Marketing authorisation holder: HOSPIRA
- Local brand name: MIDAZOLAM HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 22 July 2002
- Application: ANDA075857
- Marketing authorisation holder: HOSPIRA
- Local brand name: MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 16 July 2004
- Application: ANDA076020
- Marketing authorisation holder: INTL MEDICATION
- Local brand name: MIDAZOLAM HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 26 January 2005
- Application: ANDA076144
- Marketing authorisation holder: INTL MEDICATED
- Local brand name: MIDAZOLAM HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 9 September 2005
- Application: ANDA077115
- Marketing authorisation holder: PHARM ASSOC
- Local brand name: MIDAZOLAM HYDROCHLORIDE
- Indication: SYRUP — ORAL
- Status: approved
FDA — authorised 10 November 2008
- Application: ANDA078511
- Marketing authorisation holder: PH HEALTH
- Local brand name: MIDAZOLAM HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 25 January 2012
- Application: ANDA090850
- Marketing authorisation holder: GLAND PHARMA LTD
- Local brand name: MIDAZOLAM HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 27 December 2016
- Application: ANDA203460
- Marketing authorisation holder: FRESENIUS KABI USA
- Indication: Labeling
- Status: approved
FDA — authorised 27 April 2017
- Application: ANDA090316
- Marketing authorisation holder: ONESOURCE SPECIALTY
- Indication: Labeling
- Status: approved
FDA — authorised 27 April 2017
- Application: ANDA076379
- Marketing authorisation holder: PADAGIS US
- Indication: Labeling
- Status: approved
FDA — authorised 11 December 2020
- Application: ANDA212847
- Marketing authorisation holder: HIKMA
- Local brand name: MIDAZOLAM HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 17 January 2023
- Application: ANDA090315
- Marketing authorisation holder: ONESOURCE SPECIALTY
- Indication: Labeling
- Status: approved
FDA — authorised 21 August 2023
- Application: ANDA217504
- Marketing authorisation holder: MICRO LABS
- Local brand name: MIDAZOLAM HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 12 August 2024
- Application: ANDA218993
- Marketing authorisation holder: GLAND
- Status: approved
FDA
- Application: ANDA075263
- Marketing authorisation holder: IGI LABS INC
- Local brand name: MIDAZOLAM HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- 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 June 2000; FDA authorised it on 20 June 2000; FDA authorised it on 20 June 2000.
Who is the marketing authorisation holder for Versed in United States?
HOSPIRA holds the US marketing authorisation.