FDA — authorised 2 August 1955
- Application: NDA010040
- Marketing authorisation holder: BRACCO
- Local brand name: RENO-30
- Indication: SOLUTION — URETERAL
- Status: approved
🇺🇸 Gastrografin in United States
FDA authorised Gastrografin on 2 August 1955 · 218 US adverse-event reports
Marketing authorisations
FDA — authorised 9 November 1955
- Application: NDA010220
- Marketing authorisation holder: GE HEALTHCARE
- Local brand name: HYPAQUE-M,75%
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 17 January 1958
- Application: NDA011245
- Marketing authorisation holder: BRACCO
- Local brand name: GASTROGRAFIN
- Indication: SOLUTION — ORAL, RECTAL
- Status: approved
FDA — authorised 22 August 1958
- Application: NDA011324
- Marketing authorisation holder: BRACCO
- Local brand name: SINOGRAFIN
- Indication: SOLUTION — INTRAUTERINE
- Status: approved
FDA — authorised 3 December 1958
- Application: NDA011620
- Marketing authorisation holder: BRACCO
- Local brand name: CARDIOGRAFIN
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 21 August 1969
- Application: NDA016403
- Marketing authorisation holder: GE HEALTHCARE
- Local brand name: HYPAQUE-CYSTO
- Indication: SOLUTION — URETHRAL
- Status: approved
FDA — authorised 2 July 1980
- Application: ANDA086505
- Marketing authorisation holder: GE HEALTHCARE
- Local brand name: HYPAQUE-76
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 23 September 1982
- Application: ANDA087729
- Marketing authorisation holder: BAYER HLTHCARE
- Local brand name: UROVIST CYSTO
- Indication: SOLUTION — URETERAL
- Status: approved
FDA — authorised 23 September 1982
- Application: ANDA087723
- Marketing authorisation holder: BAYER HLTHCARE
- Local brand name: ANGIOVIST 370
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 23 September 1982
- Application: ANDA087724
- Marketing authorisation holder: BAYER HLTHCARE
- Local brand name: ANGIOVIST 292
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 23 September 1982
- Application: ANDA087726
- Marketing authorisation holder: BAYER HLTHCARE
- Local brand name: ANGIOVIST 282
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 23 September 1982
- Application: ANDA087731
- Marketing authorisation holder: BAYER HLTHCARE
- Local brand name: UROVIST CYSTO PEDIATRIC
- Indication: SOLUTION — URETERAL
- Status: approved
FDA — authorised 23 September 1982
- Application: ANDA087728
- Marketing authorisation holder: BAYER HLTHCARE
- Local brand name: GASTROVIST
- Indication: SOLUTION — ORAL, RECTAL
- Status: approved
FDA — authorised 1 June 1988
- Application: ANDA089347
- Marketing authorisation holder: BRACCO
- Local brand name: RENOCAL-76
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 27 June 2022
- Application: ANDA214201
- Marketing authorisation holder: ANDA REPOSITORY
- Local brand name: DIATRIZOATE MEGLUMINE AND DIATRIZOATE SODIUM
- Indication: SOLUTION — ORAL, RECTAL
- Status: approved
FDA
- Application: ANDA087074
- Marketing authorisation holder: MALLINCKRODT
- Local brand name: MD-60
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA087073
- Marketing authorisation holder: MALLINCKRODT
- Local brand name: MD-76
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Status: approved
Safety signals — FAERS
Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.
- Window: 27 March 2025 – 27 March 2026
- Total reports: 218
Most-reported reactions
- Urticaria — 31 reports (14.22%)
- Vomiting — 29 reports (13.3%)
- Diarrhoea — 27 reports (12.39%)
- Nausea — 25 reports (11.47%)
- No Adverse Event — 22 reports (10.09%)
- Pruritus — 19 reports (8.72%)
- Drug Ineffective — 17 reports (7.8%)
- Dyspnoea — 17 reports (7.8%)
- Off Label Use — 17 reports (7.8%)
- Hypotension — 14 reports (6.42%)
Other Gastroenterology approved in United States
Frequently asked questions
Is Gastrografin approved in United States?
Yes. FDA authorised it on 2 August 1955; FDA authorised it on 9 November 1955; FDA authorised it on 17 January 1958.
Who is the marketing authorisation holder for Gastrografin in United States?
BRACCO holds the US marketing authorisation.