FDA — authorised 7 December 1964
- Application: ANDA060611
- Marketing authorisation holder: PHARMACIA AND UPJOHN
- Status: supplemented
🇺🇸 "Neo-Bladder" Construct in United States
FDA authorised "Neo-Bladder" Construct on 7 December 1964
Marketing authorisations
FDA — authorised 3 August 1999
- Application: NDA021012
- Marketing authorisation holder: CIS BIO INTL SA
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 17 September 2001
- Application: NDA008592
- Marketing authorisation holder: EASTMAN KODAK
- Indication: Labeling
- Status: approved
FDA — authorised 23 May 2002
- Application: ANDA065010
- Marketing authorisation holder: X GEN PHARMS
- Indication: Labeling
- Status: approved
"Neo-Bladder" Construct in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is "Neo-Bladder" Construct approved in United States?
Yes. FDA authorised it on 7 December 1964; FDA authorised it on 3 August 1999; FDA authorised it on 17 September 2001.
Who is the marketing authorisation holder for "Neo-Bladder" Construct in United States?
PHARMACIA AND UPJOHN holds the US marketing authorisation.