FDA — authorised 21 May 1962
- Marketing authorisation holder: ORTHO MCNEIL PHARM
- Status: approved
🇺🇸 Micronor in United States
FDA authorised Micronor on 21 May 1962
Marketing authorisations
FDA — authorised 2 January 1973
- Application: NDA016954
- Marketing authorisation holder: JANSSEN PHARMS
- Local brand name: MICRONOR
- Indication: TABLET — ORAL-28
- Status: approved
FDA — authorised 17 December 2025
- Application: NDA213388
- Marketing authorisation holder: ABBVIE
- Indication: Labeling
- Status: approved
The FDA approved Micronor, a drug product, on December 17, 2025. The marketing authorization was granted to AbbVie, the marketing authorization holder, under NDA213388. The approved indication for Micronor is labeling.
Micronor 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 Micronor approved in United States?
Yes. FDA authorised it on 21 May 1962; FDA authorised it on 2 January 1973; FDA authorised it on 17 December 2025.
Who is the marketing authorisation holder for Micronor in United States?
ORTHO MCNEIL PHARM holds the US marketing authorisation.