FDA — authorised 22 August 2002
- Application: NDA021241
- Marketing authorisation holder: JANSSEN PHARMS
- Local brand name: ORTHO TRI-CYCLEN LO
- Indication: TABLET — ORAL-28
- Status: approved
FDA authorised Ortho Tri-Cyclen LO on 22 August 2002
Yes. FDA authorised it on 22 August 2002.
JANSSEN PHARMS holds the US marketing authorisation.