FDA — authorised 9 January 1947
- Marketing authorisation holder: ORTHO MCNEIL PHARM
- Status: approved
🇺🇸 Synestrol in United States
FDA authorised Synestrol on 9 January 1947
Marketing authorisations
FDA — authorised 9 January 1947
- Application: NDA006110
- Marketing authorisation holder: ORTHO MCNEIL PHARM
- Local brand name: DIENESTROL
- Indication: CREAM — VAGINAL
- Status: approved
Synestrol 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 Synestrol approved in United States?
Yes. FDA authorised it on 9 January 1947; FDA authorised it on 9 January 1947.
Who is the marketing authorisation holder for Synestrol in United States?
ORTHO MCNEIL PHARM holds the US marketing authorisation.