FDA — authorised 13 December 2002
- Application: NDA021473
- Marketing authorisation holder: BAYER HLTHCARE
- Local brand name: CIPRO XR
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
🇺🇸 CIPRO®XR in United States
FDA authorised CIPRO®XR on 13 December 2002
Marketing authorisations
FDA — authorised 28 August 2003
- Application: NDA021554
- Marketing authorisation holder: BAYER PHARMS
- Local brand name: CIPRO XR
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
Frequently asked questions
Is CIPRO®XR approved in United States?
Yes. FDA authorised it on 13 December 2002; FDA authorised it on 28 August 2003.
Who is the marketing authorisation holder for CIPRO®XR in United States?
BAYER HLTHCARE holds the US marketing authorisation.