FDA — authorised 20 February 2003
- Application: ANDA070929
- Marketing authorisation holder: ACTAVIS LABS FL INC
- Status: approved
🇺🇸 Nolvadex in United States
FDA authorised Nolvadex on 20 February 2003
Marketing authorisations
FDA — authorised 18 August 2005
- Application: ANDA075797
- Marketing authorisation holder: DR REDDYS LABS SA
- Indication: Labeling
- Status: approved
FDA — authorised 2 March 2006
- Application: ANDA074732
- Marketing authorisation holder: MYLAN
- Indication: Labeling
- Status: approved
FDA — authorised 22 April 2015
- Application: NDA021807
- Marketing authorisation holder: MAYNE PHARMA COMMRCL
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 14 August 2020
- Application: ANDA213358
- Marketing authorisation holder: EUGIA PHARMA
- Status: approved
Nolvadex 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 Nolvadex approved in United States?
Yes. FDA authorised it on 20 February 2003; FDA authorised it on 18 August 2005; FDA authorised it on 2 March 2006.
Who is the marketing authorisation holder for Nolvadex in United States?
ACTAVIS LABS FL INC holds the US marketing authorisation.