FDA — authorised 4 April 2003
- Application: NDA021158
- Marketing authorisation holder: LG CHEM LTD
- Local brand name: FACTIVE
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Factive in United States
FDA authorised Factive on 4 April 2003
Marketing authorisations
FDA — authorised 15 June 2015
- Application: ANDA090466
- Marketing authorisation holder: ORBION PHARMS
- Local brand name: GEMIFLOXACIN MESYLATE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Status: approved
Factive in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Infectious Disease approved in United States
Frequently asked questions
Is Factive approved in United States?
Yes. FDA authorised it on 4 April 2003; FDA authorised it on 15 June 2015; FDA has authorised it.
Who is the marketing authorisation holder for Factive in United States?
LG CHEM LTD holds the US marketing authorisation.