FDA — authorised 3 July 1992
- Application: NDA019697
- Marketing authorisation holder: JANSSEN PHARMS
- Local brand name: ORTHO TRI-CYCLEN
- Indication: TABLET — ORAL-21
- Status: approved
🇺🇸 Ortho Tri Cyclen in United States
FDA authorised Ortho Tri Cyclen on 3 July 1992
Marketing authorisation
Other Contraception / Gynecology approved in United States
Frequently asked questions
Is Ortho Tri Cyclen approved in United States?
Yes. FDA authorised it on 3 July 1992.
Who is the marketing authorisation holder for Ortho Tri Cyclen in United States?
JANSSEN PHARMS holds the US marketing authorisation.