FDA
- Marketing authorisation holder: BRISTOL
- Status: approved
🇺🇸 Etacillin in United States
Etacillin (HETACILLIN) regulatory status in United States.
Marketing authorisations
FDA
- Application: NDA050060
- Marketing authorisation holder: BRISTOL
- Local brand name: VERSAPEN
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA
- Application: ANDA061398
- Marketing authorisation holder: BRISTOL
- Local brand name: VERSAPEN
- Indication: FOR SUSPENSION — ORAL
- Status: approved
Etacillin 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 Etacillin approved in United States?
Yes. FDA has authorised it; FDA has authorised it; FDA has authorised it.
Who is the marketing authorisation holder for Etacillin in United States?
BRISTOL holds the US marketing authorisation.