Source facts
FDA issued an approval letter for METRO I.V. IN PLASTIC CONTAINER on 2026-04-27. The source metadata identifies NDA 018900 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
US FDA source recordAL · Approval Letter
METRO I.V. IN PLASTIC CONTAINER — FDA Approval Letter (NDA 018900)
Issued to B BRAUN. Application is approved as submitted.
Issued
April 27, 2026Application
NDA 505b1 • 018900
Product
METRO I.V. IN PLASTIC CONTAINER
Company
B BRAUN
Stage
Final Decision
Assyro regulatory brief
FreeWhat did FDA decide for METRO I.V. IN PLASTIC CONTAINER?
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Key details in this letter
- 1FDA action: approval.
- 2Application: NDA 018900.
- 3Submission: supplement.
- 4Sponsor: B BRAUN.
Suggested next step
Review the exact FDA letter for approved conditions, labeling, and postmarketing requirements.
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Common questions about the METRO I.V. IN PLASTIC CONTAINER approval letter
Is METRO I.V. IN PLASTIC CONTAINER FDA approved?
This letter documents an FDA approval action: FDA approved NDA 018900 for METRO I.V. IN PLASTIC CONTAINER, sponsored by B BRAUN, on April 27, 2026. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.
What is NDA 018900?
NDA 018900 is the application under which FDA issued this approval letter for METRO I.V. IN PLASTIC CONTAINER to B BRAUN. The letter is dated April 27, 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.