FDA — authorised 2 August 1955
- Application: NDA010040
- Marketing authorisation holder: BRACCO
- Local brand name: CYSTOGRAFIN DILUTE
- Indication: SOLUTION — URETHRAL
- Status: approved
🇺🇸 Cystografin Dilute in United States
FDA authorised Cystografin Dilute on 2 August 1955
Marketing authorisations
FDA — authorised 2 August 1955
- Marketing authorisation holder: BRACCO
- Status: approved
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 22 August 1958
- Application: NDA011324
- Marketing authorisation holder: BRACCO
- Local brand name: SINOGRAFIN
- Indication: SOLUTION — INTRAUTERINE
- 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 2 February 1983
- Application: NDA011245
- Marketing authorisation holder: BRACCO
- Indication: Labeling
- Status: approved
FDA — authorised 21 March 1986
- Application: ANDA087388
- Marketing authorisation holder: LIEBEL-FLARSHEIM
- Indication: Manufacturing (CMC)
- 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
- Status: approved
FDA — authorised 17 November 2023
- Application: ANDA215049
- Marketing authorisation holder: ANNORA PHARMA
- 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
Cystografin Dilute in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Other approved in United States
Frequently asked questions
Is Cystografin Dilute approved in United States?
Yes. FDA authorised it on 2 August 1955; FDA authorised it on 2 August 1955; FDA authorised it on 9 November 1955.
Who is the marketing authorisation holder for Cystografin Dilute in United States?
BRACCO holds the US marketing authorisation.