FDA — authorised 24 December 1991
- Application: NDA019836
- Marketing authorisation holder: SHIRE
- Local brand name: SUPPRELIN
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 HISTRELIN ACETATE in United States
FDA authorised HISTRELIN ACETATE on 24 December 1991
Marketing authorisations
FDA
- Status: approved
HISTRELIN ACETATE in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is HISTRELIN ACETATE approved in United States?
Yes. FDA authorised it on 24 December 1991; FDA has authorised it.
Who is the marketing authorisation holder for HISTRELIN ACETATE in United States?
SHIRE holds the US marketing authorisation.