FDA — authorised 19 September 1996
- Marketing authorisation holder: CONCORDIA PHARMS INC
- Status: approved
🇺🇸 Nilandron in United States
FDA authorised Nilandron on 19 September 1996
Marketing authorisations
FDA — authorised 19 September 1996
- Application: NDA020169
- Marketing authorisation holder: ADVANZ PHARMA
- Local brand name: NILANDRON
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 15 July 2016
- Application: ANDA207631
- Marketing authorisation holder: ANI PHARMS
- Local brand name: NILUTAMIDE
- Indication: TABLET — ORAL
- Status: approved
Nilandron in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Oncology approved in United States
Frequently asked questions
Is Nilandron approved in United States?
Yes. FDA authorised it on 19 September 1996; FDA authorised it on 19 September 1996; FDA authorised it on 15 July 2016.
Who is the marketing authorisation holder for Nilandron in United States?
CONCORDIA PHARMS INC holds the US marketing authorisation.