FDA — authorised 27 December 1985
- Application: NDA050588
- Marketing authorisation holder: PAI HOLDINGS PHARM
- Local brand name: CEFOTAN
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 Cefotan in United States
FDA authorised Cefotan on 27 December 1985
Marketing authorisations
FDA — authorised 29 April 1993
- Application: ANDA063293
- Marketing authorisation holder: TELIGENT
- Local brand name: CEFOTAN
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 9 August 2007
- Application: ANDA065374
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: CEFOTETAN
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 9 August 2007
- Application: ANDA065375
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: CEFOTETAN
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 26 October 2011
- Application: ANDA091030
- Marketing authorisation holder: WEST-WARD PHARM CORP
- Local brand name: CEFOTETAN
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 26 October 2011
- Application: ANDA091031
- Marketing authorisation holder: HIKMA
- Local brand name: CEFOTETAN
- Indication: INJECTABLE — INJECTION
- Status: approved
Cefotan 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 Cefotan approved in United States?
Yes. FDA authorised it on 27 December 1985; FDA authorised it on 29 April 1993; FDA authorised it on 9 August 2007.
Who is the marketing authorisation holder for Cefotan in United States?
PAI HOLDINGS PHARM holds the US marketing authorisation.