Source facts
FDA issued an approval letter for ISOVUE-M 200, ISOVUE-300, ISOVUE-370 on 2026-06-23. The source metadata identifies NDA 018735, NDA 020327 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
US FDA source recordAL · Approval Letter
ISOVUE-M 200 / ISOVUE-300 / ISOVUE-370 — FDA Approval Letter (NDA 018735)
Issued to BRACCO. Application is approved as submitted.
Issued
June 23, 2026Application
NDA 505b1 • 018735
Product
ISOVUE-M 200 / ISOVUE-300 / ISOVUE-370
Company
BRACCO
Stage
Final Decision
Assyro regulatory brief
FreeWhat did FDA decide for ISOVUE-M 200 / ISOVUE-300 / ISOVUE-370?
Source facts and Assyro context are separated so you can scan the action quickly without treating analysis as an FDA conclusion.
Key details in this letter
- 1FDA action: approval.
- 2Applications: NDA 018735, NDA 020327.
- 3Submission: supplement.
- 4Sponsor: BRACCO.
Suggested next step
Review the exact FDA letter for approved conditions, labeling, and postmarketing requirements.
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Common questions about the ISOVUE-M 200 / ISOVUE-300 / ISOVUE-370 approval letter
Is ISOVUE-M 200 / ISOVUE-300 / ISOVUE-370 FDA approved?
This letter documents an FDA approval action: FDA approved NDA 018735 for ISOVUE-M 200 / ISOVUE-300 / ISOVUE-370, sponsored by BRACCO, on June 23, 2026. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.
What is NDA 018735?
NDA 018735 is the application under which FDA issued this approval letter for ISOVUE-M 200 / ISOVUE-300 / ISOVUE-370 to BRACCO. The letter is dated June 23, 2026.
What happens after an FDA approval letter?
The sponsor may market the product in line with the approved labeling. Approval letters typically set post-approval obligations: submitting final content of labeling, meeting any postmarketing requirements or commitments listed in the letter, updating Orange Book patent information within 30 days for NDAs, and ongoing annual reporting under 21 CFR 314.81.