FDA — authorised 12 June 1941
- Application: NDA003977
- Marketing authorisation holder: PARKEDALE
- Local brand name: THEELIN
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA authorised Estron on 12 June 1941
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Yes. FDA authorised it on 12 June 1941; FDA authorised it on 21 February 1979; FDA has authorised it.
PARKEDALE holds the US marketing authorisation.