FDA
- Status: approved
🇺🇸 ULTRACEF in United States
ULTRACEF (CEFADROXIL/CEFADROXIL HEMIHYDRATE) regulatory status in United States.
Marketing authorisations
FDA
- Application: ANDA062376
- Marketing authorisation holder: BRISTOL
- Local brand name: ULTRACEF
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA
- Application: ANDA062378
- Marketing authorisation holder: BRISTOL
- Local brand name: ULTRACEF
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Application: ANDA062390
- Marketing authorisation holder: APOTHECON
- Local brand name: ULTRACEF
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA062408
- Marketing authorisation holder: BRISTOL
- Local brand name: ULTRACEF
- Indication: TABLET — ORAL
- Status: approved
ULTRACEF in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Other approved in United States
Frequently asked questions
Is ULTRACEF approved in United States?
Yes. FDA has authorised it; FDA has authorised it; FDA has authorised it.
Who is the marketing authorisation holder for ULTRACEF in United States?
BRISTOL is the originator. The local marketing authorisation holder may differ — check the official source linked above.