FDA — authorised 22 October 1987
- Application: NDA019537
- Marketing authorisation holder: BAYER HLTHCARE
- Local brand name: CIPRO
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Cipro in United States
FDA authorised Cipro on 22 October 1987
Marketing authorisations
FDA — authorised 26 December 1990
- Application: NDA019858
- Marketing authorisation holder: BAYER PHARMS
- Local brand name: CIPRO IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 26 December 1990
- Application: NDA019857
- Marketing authorisation holder: BAYER HLTHCARE
- Local brand name: CIPRO IN DEXTROSE 5% IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 26 December 1990
- Application: NDA019847
- Marketing authorisation holder: BAYER HLTHCARE
- Local brand name: CIPRO
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 31 December 1990
- Application: NDA019992
- Marketing authorisation holder: SANDOZ
- Local brand name: CILOXAN
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 26 September 1997
- Application: NDA020780
- Marketing authorisation holder: BAYER HLTHCARE
- Local brand name: CIPRO
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 30 March 1998
- Application: NDA020369
- Marketing authorisation holder: SANDOZ
- Local brand name: CILOXAN
- Indication: OINTMENT — OPHTHALMIC
- Status: approved
FDA — authorised 16 March 2004
- Application: ANDA076593
- Marketing authorisation holder: AIPING PHARM INC
- Local brand name: CIPROFLOXACIN
- Indication: Tablet — Oral
- Status: approved
FDA — authorised 9 June 2004
- Application: ANDA076089
- Marketing authorisation holder: IVAX SUB TEVA PHARMS
- Local brand name: CIPROFLOXACIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 9 June 2004
- Application: ANDA076126
- Marketing authorisation holder: CARLSBAD
- Local brand name: CIPROFLOXACIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 9 June 2004
- Application: ANDA076558
- Marketing authorisation holder: HIKMA
- Local brand name: CIPROFLOXACIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 29 June 2005
- Application: ANDA076896
- Marketing authorisation holder: CHARTWELL
- Indication: Labeling
- Status: approved
FDA — authorised 28 August 2006
- Application: ANDA076484
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: CIPROFLOXACIN
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 28 August 2006
- Application: ANDA077245
- Marketing authorisation holder: HOSPIRA
- Local brand name: CIPROFLOXACIN
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 28 August 2006
- Application: ANDA077782
- Marketing authorisation holder: DR REDDYS
- Local brand name: CIPROFLOXACIN
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 26 March 2007
- Application: ANDA077701
- Marketing authorisation holder: DR REDDYS LABS LTD
- Local brand name: CIPROFLOXACIN EXTENDED RELEASE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 27 November 2007
- Application: ANDA078166
- Marketing authorisation holder: PH HEALTH
- Local brand name: CIPROFLOXACIN EXTENDED RELEASE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 11 December 2007
- Application: ANDA078712
- Marketing authorisation holder: FOSUN PHARMA
- Local brand name: CIPROFLOXACIN EXTENDED RELEASE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 21 April 2008
- Application: ANDA076757
- Marketing authorisation holder: HIKMA FARMACEUTICA
- Local brand name: CIPROFLOXACIN IN DEXTROSE 5%
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 29 April 2008
- Application: ANDA078062
- Marketing authorisation holder: BAXTER HLTHCARE CORP
- Local brand name: CIPROFLOXACIN
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 2 December 2008
- Application: ANDA077859
- Marketing authorisation holder: AUROBINDO PHARMA
- Indication: Labeling
- Status: approved
FDA — authorised 30 November 2010
- Application: ANDA077809
- Marketing authorisation holder: ANI PHARMS
- Local brand name: CIPROFLOXACIN EXTENDED RELEASE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 3 May 2018
- Application: ANDA204613
- Marketing authorisation holder: ALTAIRE PHARMS INC
- 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.
Other Neuroscience approved in United States
Frequently asked questions
Is Cipro approved in United States?
Yes. FDA authorised it on 22 October 1987; FDA authorised it on 26 December 1990; FDA authorised it on 26 December 1990.
Who is the marketing authorisation holder for Cipro in United States?
BAYER HLTHCARE holds the US marketing authorisation.