Source facts
FDA issued an approval letter for CEFEPIME AND DEXTROSE IN DUPLEX CONTAINER on 2026-04-09. The source metadata identifies NDA 050821 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
US FDA source recordAL · Approval Letter
CEFEPIME AND DEXTROSE IN DUPLEX CONTAINER — FDA Approval Letter (NDA 050821)
Issued to B BRAUN. Application is approved as submitted.
Issued
April 9, 2026Application
NDA 505b1 • 050821
Product
CEFEPIME AND DEXTROSE IN DUPLEX CONTAINER
Company
B BRAUN
Stage
Final Decision
Assyro regulatory brief
FreeWhat did FDA decide for CEFEPIME AND DEXTROSE IN DUPLEX CONTAINER?
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Key details in this letter
- 1FDA action: approval.
- 2Application: NDA 050821.
- 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 CEFEPIME AND DEXTROSE IN DUPLEX CONTAINER approval letter
Is CEFEPIME AND DEXTROSE IN DUPLEX CONTAINER FDA approved?
This letter documents an FDA approval action: FDA approved NDA 050821 for CEFEPIME AND DEXTROSE IN DUPLEX CONTAINER, sponsored by B BRAUN, on April 9, 2026. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.
What is NDA 050821?
NDA 050821 is the application under which FDA issued this approval letter for CEFEPIME AND DEXTROSE IN DUPLEX CONTAINER to B BRAUN. The letter is dated April 9, 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.