FDA — authorised 18 March 2008
- Application: ANDA078024
- Marketing authorisation holder: BAXTER HLTHCARE CORP
- Local brand name: CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 Cipro in United States
FDA authorised Cipro on 18 March 2008
Marketing authorisations
FDA — authorised 18 March 2008
- Application: ANDA078252
- Marketing authorisation holder: INFORLIFE
- Local brand name: CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 18 March 2008
- Application: ANDA077753
- Marketing authorisation holder: HOSPIRA
- Local brand name: CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 18 March 2008
- Application: ANDA078114
- Marketing authorisation holder: BEDFORD
- Local brand name: CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 18 November 2009
- Application: ANDA078431
- Marketing authorisation holder: HIKMA FARMACEUTICA
- Local brand name: CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA077138
- Marketing authorisation holder: TEVA PHARMS
- Local brand name: CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Status: approved
Cipro in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is Cipro approved in United States?
Yes. FDA authorised it on 18 March 2008; FDA authorised it on 18 March 2008; FDA authorised it on 18 March 2008.
Who is the marketing authorisation holder for Cipro in United States?
BAXTER HLTHCARE CORP holds the US marketing authorisation.