FDA — authorised 9 September 1971
- Application: ANDA060569
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: FULVICIN-U/F
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 GRISEOFULVIN in United States
FDA authorised GRISEOFULVIN on 9 September 1971
Marketing authorisations
FDA — authorised 2 March 2005
- Application: ANDA065200
- Marketing authorisation holder: CHARTWELL RX
- Status: approved
GRISEOFULVIN in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Dermatology approved in United States
Frequently asked questions
Is GRISEOFULVIN approved in United States?
Yes. FDA authorised it on 9 September 1971; FDA authorised it on 2 March 2005.
Who is the marketing authorisation holder for GRISEOFULVIN in United States?
CHARTWELL RX holds the US marketing authorisation.