FDA — authorised 26 November 1954
- Application: NDA009561
- Marketing authorisation holder: GE HEALTHCARE
- Local brand name: HYPAQUE
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 DIATRIZOATE SODIUM in United States
FDA authorised DIATRIZOATE SODIUM on 26 November 1954
Marketing authorisations
FDA — authorised 26 March 1956
- Application: NDA011386
- Marketing authorisation holder: GE HEALTHCARE
- Local brand name: HYPAQUE
- Indication: FOR SOLUTION — ORAL, RECTAL
- Status: approved
FDA — authorised 23 September 1982
- Application: ANDA087725
- Marketing authorisation holder: BAYER HLTHCARE
- Local brand name: UROVIST SODIUM 300
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 15 November 1984
- Application: ANDA087075
- Marketing authorisation holder: MALLINCKRODT
- Local brand name: MD-50
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Status: approved
DIATRIZOATE SODIUM 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 DIATRIZOATE SODIUM approved in United States?
Yes. FDA authorised it on 26 November 1954; FDA authorised it on 26 March 1956; FDA authorised it on 23 September 1982.
Who is the marketing authorisation holder for DIATRIZOATE SODIUM in United States?
GE HEALTHCARE holds the US marketing authorisation.