FDA — authorised 25 June 1943
- Marketing authorisation holder: SCHERING
- Status: approved
🇺🇸 Ortho-Novum 10/11-21 in United States
FDA authorised Ortho-Novum 10/11-21 on 25 June 1943
Marketing authorisations
FDA — authorised 11 January 1982
- Application: NDA018354
- Marketing authorisation holder: ORTHO MCNEIL JANSSEN
- Local brand name: ORTHO-NOVUM 10/11-21
- Indication: TABLET — ORAL-21
- Status: approved
Ortho-Novum 10/11-21 in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Bone approved in United States
Frequently asked questions
Is Ortho-Novum 10/11-21 approved in United States?
Yes. FDA authorised it on 25 June 1943; FDA authorised it on 11 January 1982.
Who is the marketing authorisation holder for Ortho-Novum 10/11-21 in United States?
SCHERING holds the US marketing authorisation.