🇺🇸 Ortho Tri-Cyclen LO in United States

FDA authorised Ortho Tri-Cyclen LO on 22 August 2002

Marketing authorisation

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

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Other Contraception / Gynecology approved in United States

Frequently asked questions

Is Ortho Tri-Cyclen LO approved in United States?

Yes. FDA authorised it on 22 August 2002.

Who is the marketing authorisation holder for Ortho Tri-Cyclen LO in United States?

JANSSEN PHARMS holds the US marketing authorisation.