FDA — authorised 29 August 2001
- Application: NDA021222
- Marketing authorisation holder: VANSEN PHARMA
- Local brand name: SPECTRACEF
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Cefditoren Pivoxyl in United States
FDA authorised Cefditoren Pivoxyl on 29 August 2001
Marketing authorisations
FDA
- Status: approved
Cefditoren Pivoxyl 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 Cefditoren Pivoxyl approved in United States?
Yes. FDA authorised it on 29 August 2001; FDA has authorised it.
Who is the marketing authorisation holder for Cefditoren Pivoxyl in United States?
VANSEN PHARMA holds the US marketing authorisation.