FDA — authorised 6 April 1982
- Application: ANDA061996
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: FULVICIN P/G 165
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 FULVICIN P/G 330 in United States
FDA authorised FULVICIN P/G 330 on 6 April 1982
Marketing authorisations
FDA — authorised 22 October 2012
- Application: ANDA202545
- Marketing authorisation holder: SIGMAPHARM LABS LLC
- Local brand name: GRISEOFULVIN,ULTRAMICROSIZE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 9 January 2014
- Application: ANDA204371
- Marketing authorisation holder: MOUNTAIN
- Local brand name: GRISEOFULVIN, ULTRAMICROSIZE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 26 December 2018
- Application: ANDA202805
- Marketing authorisation holder: SANDOZ
- Local brand name: GRISEOFULVIN, ULTRAMICROSIZE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Status: approved
FULVICIN P/G 330 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 FULVICIN P/G 330 approved in United States?
Yes. FDA authorised it on 6 April 1982; FDA authorised it on 22 October 2012; FDA authorised it on 9 January 2014.
Who is the marketing authorisation holder for FULVICIN P/G 330 in United States?
CHARTWELL RX holds the US marketing authorisation.