FDA — authorised 12 July 2002
- Application: ANDA040256
- Marketing authorisation holder: PH HEALTH
- Status: supplemented
🇺🇸 NOVA63035 "Corticosteroid" in United States
FDA authorised NOVA63035 "Corticosteroid" on 12 July 2002
Marketing authorisations
FDA — authorised 8 April 2005
- Application: NDA021737
- Marketing authorisation holder: BAUSCH AND LOMB
- Status: supplemented
FDA — authorised 25 April 2016
- Application: ANDA090982
- Marketing authorisation holder: RISING
- Status: approved
FDA — authorised 20 November 2019
- Application: ANDA210198
- Marketing authorisation holder: CADILA
- Status: approved
FDA — authorised 17 October 2025
- Application: ANDA218601
- Marketing authorisation holder: ALEMBIC
- Status: approved
Frequently asked questions
Is NOVA63035 "Corticosteroid" approved in United States?
Yes. FDA authorised it on 12 July 2002; FDA authorised it on 8 April 2005; FDA authorised it on 25 April 2016.
Who is the marketing authorisation holder for NOVA63035 "Corticosteroid" in United States?
PH HEALTH holds the US marketing authorisation.