FDA — authorised 22 August 1962
- Marketing authorisation holder: WYETH AYERST
- Status: approved
🇺🇸 Grifulvin V in United States
FDA authorised Grifulvin V on 22 August 1962
Marketing authorisations
FDA — authorised 14 July 1971
- Application: ANDA060618
- Marketing authorisation holder: J AND J
- Local brand name: GRIFULVIN V
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 2 June 1980
- Application: ANDA062279
- Marketing authorisation holder: VALEANT LUXEMBOURG
- Local brand name: GRIFULVIN V
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 6 April 1982
- Application: ANDA061996
- Marketing authorisation holder: CHARTWELL RX
- Status: approved
FDA — authorised 26 January 1984
- Application: ANDA062483
- Marketing authorisation holder: VALEANT LUXEMBOURG
- Local brand name: GRIFULVIN V
- Indication: SUSPENSION — ORAL
- Status: approved
FDA — authorised 26 January 2001
- Application: ANDA060569
- Marketing authorisation holder: CHARTWELL RX
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 6 July 2007
- Application: ANDA065394
- Marketing authorisation holder: ACTAVIS MID ATLANTIC
- Local brand name: GRISEOFULVIN
- Indication: SUSPENSION — ORAL
- Status: approved
FDA — authorised 10 September 2007
- Application: ANDA065354
- Marketing authorisation holder: CIPLA
- Local brand name: GRISEOFULVIN
- Indication: SUSPENSION — ORAL
- Status: approved
FDA — authorised 8 October 2010
- Application: ANDA065438
- Marketing authorisation holder: COSETTE
- Local brand name: GRISEOFULVIN
- Indication: SUSPENSION — ORAL
- Status: approved
FDA — authorised 22 October 2012
- Application: ANDA202482
- Marketing authorisation holder: SIGMAPHARM LABS LLC
- Local brand name: GRISEOFULVIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 7 August 2013
- Application: ANDA091592
- Marketing authorisation holder: SANDOZ
- Local brand name: GRISEOFULVIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 26 December 2018
- Application: ANDA202805
- Marketing authorisation holder: SANDOZ
- Status: approved
Grifulvin V 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 Grifulvin V approved in United States?
Yes. FDA authorised it on 22 August 1962; FDA authorised it on 14 July 1971; FDA authorised it on 2 June 1980.
Who is the marketing authorisation holder for Grifulvin V in United States?
WYETH AYERST holds the US marketing authorisation.