FDA — authorised 11 March 1981
- Application: NDA050547
- Marketing authorisation holder: STERIMAX
- Local brand name: CLAFORAN
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 Claforan in United States
FDA authorised Claforan on 11 March 1981
Marketing authorisations
FDA — authorised 13 January 1987
- Application: ANDA062659
- Marketing authorisation holder: SANOFI AVENTIS US
- Local brand name: CLAFORAN
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 24 March 2000
- Application: ANDA064200
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: CEFOTAXIME
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 24 March 2000
- Application: ANDA064201
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: CEFOTAXIME
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 20 November 2002
- Application: ANDA065072
- Marketing authorisation holder: HIKMA
- Local brand name: CEFOTAXIME
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 20 November 2002
- Application: ANDA065071
- Marketing authorisation holder: HIKMA
- Local brand name: CEFOTAXIME
- Indication: INJECTABLE — INJECTION
- Status: approved
Claforan in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Immunology approved in United States
Frequently asked questions
Is Claforan approved in United States?
Yes. FDA authorised it on 11 March 1981; FDA authorised it on 13 January 1987; FDA authorised it on 24 March 2000.
Who is the marketing authorisation holder for Claforan in United States?
STERIMAX holds the US marketing authorisation.