FDA — authorised 16 June 1954
- Application: NDA008975
- Marketing authorisation holder: ANI PHARMS
- Indication: Type 5 - New Formulation or New Manufacturer
- Status: approved
🇺🇸 H.P. ACTHAR GEL in United States
FDA authorised H.P. ACTHAR GEL on 16 June 1954
Marketing authorisations
FDA — authorised 5 April 1994
- Application: NDA008372
- Marketing authorisation holder: MALLINCKRODT IRELAND
- Indication: Manufacturing (CMC)
- Status: approved
H.P. ACTHAR GEL in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Other approved in United States
Frequently asked questions
Is H.P. ACTHAR GEL approved in United States?
Yes. FDA authorised it on 16 June 1954; FDA authorised it on 5 April 1994.
Who is the marketing authorisation holder for H.P. ACTHAR GEL in United States?
ANI PHARMS holds the US marketing authorisation.