FDA — authorised 22 December 1976
- Application: NDA017698
- Marketing authorisation holder: HOSPIRA
- Local brand name: STERILE UREA
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 UREA in United States
FDA authorised UREA on 22 December 1976
Marketing authorisations
FDA — authorised 17 December 2002
- Application: NDA021314
- Marketing authorisation holder: MERIDIAN BIOSCIENCE
- Indication: Type 3 - New Dosage Form
- Status: approved
UREA 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 UREA approved in United States?
Yes. FDA authorised it on 22 December 1976; FDA authorised it on 17 December 2002.
Who is the marketing authorisation holder for UREA in United States?
HOSPIRA holds the US marketing authorisation.