FDA — authorised 13 March 1980
- Application: ANDA062178
- Marketing authorisation holder: WYETH AYERST
- Local brand name: GRISACTIN ULTRA
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 GRISACTIN ULTRA in United States
FDA authorised GRISACTIN ULTRA on 13 March 1980
Marketing authorisations
FDA — authorised 30 June 1992
- Application: ANDA062645
- Marketing authorisation holder: PLIVA
- Local brand name: ULTRAGRIS-165
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 30 June 1992
- Application: ANDA062646
- Marketing authorisation holder: PLIVA
- Local brand name: ULTRAGRIS-330
- Indication: TABLET — ORAL
- Status: approved
FDA
- Status: approved
GRISACTIN ULTRA 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 GRISACTIN ULTRA approved in United States?
Yes. FDA authorised it on 13 March 1980; FDA authorised it on 30 June 1992; FDA authorised it on 30 June 1992.
Who is the marketing authorisation holder for GRISACTIN ULTRA in United States?
WYETH AYERST holds the US marketing authorisation.