FDA — authorised 20 December 1991
- Status: approved
🇺🇸 Romazicon in United States
FDA authorised Romazicon on 20 December 1991
Marketing authorisations
FDA — authorised 12 October 2004
- Application: ANDA076256
- Marketing authorisation holder: HIKMA
- Local brand name: FLUMAZENIL
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 12 October 2004
- Application: ANDA076755
- Marketing authorisation holder: BAXTER HLTHCARE CORP
- Local brand name: FLUMAZENIL
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 12 October 2004
- Application: ANDA076787
- Marketing authorisation holder: HIKMA
- Local brand name: FLUMAZENIL
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 12 October 2004
- Application: ANDA076955
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: FLUMAZENIL
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 12 October 2004
- Application: ANDA076589
- Marketing authorisation holder: DR REDDYS
- Local brand name: FLUMAZENIL
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 3 May 2005
- Application: ANDA077071
- Marketing authorisation holder: SANDOZ
- Local brand name: FLUMAZENIL
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 13 May 2008
- Application: ANDA078595
- Marketing authorisation holder: RISING
- Local brand name: FLUMAZENIL
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 23 March 2009
- Application: ANDA078527
- Marketing authorisation holder: HIKMA FARMACEUTICA
- Local brand name: FLUMAZENIL
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 28 August 2012
- Application: ANDA090584
- Marketing authorisation holder: SAGENT PHARMS
- Local brand name: FLUMAZENIL
- Indication: INJECTABLE — INJECTION
- Status: approved
Romazicon in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Other approved in United States
Frequently asked questions
Is Romazicon approved in United States?
Yes. FDA authorised it on 20 December 1991; FDA authorised it on 12 October 2004; FDA authorised it on 12 October 2004.
Who is the marketing authorisation holder for Romazicon in United States?
Marketing authorisation holder not available in our data.