FDA — authorised 1 December 2003
- Application: ANDA076656
- Marketing authorisation holder: LUITPOLD
- Local brand name: FENOLDOPAM MESYLATE
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 Intra-Renal Fenoldopam in United States
FDA authorised Intra-Renal Fenoldopam on 1 December 2003
Marketing authorisations
FDA — authorised 12 October 2004
- Application: ANDA076582
- Marketing authorisation holder: HIKMA
- Local brand name: FENOLDOPAM MESYLATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 15 February 2005
- Application: ANDA077155
- Marketing authorisation holder: SANDOZ
- Local brand name: FENOLDOPAM MESYLATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 7 March 2007
- Application: ANDA077826
- Marketing authorisation holder: TEVA PARENTERAL
- Local brand name: FENOLDOPAM MESYLATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Status: approved
Intra-Renal Fenoldopam 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 Intra-Renal Fenoldopam approved in United States?
Yes. FDA authorised it on 1 December 2003; FDA authorised it on 12 October 2004; FDA authorised it on 15 February 2005.
Who is the marketing authorisation holder for Intra-Renal Fenoldopam in United States?
LUITPOLD holds the US marketing authorisation.