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US FDA source recordAL · Approval Letter

DEXTROSE 5% IN PLASTIC CONTAINER — FDA Approval Letter (NDA 016730)

Issued to B BRAUN. Application is approved as submitted.

Issued

May 13, 2026

Application

NDA 505b1 • 016730

Product

DEXTROSE 5% IN PLASTIC CONTAINER

Company

B BRAUN

Stage

Final Decision

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What did FDA decide for DEXTROSE 5% IN PLASTIC CONTAINER?

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Source facts

FDA issued an approval letter for DEXTROSE 5% IN PLASTIC CONTAINER on 2026-05-13. The source metadata identifies NDA 016730 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

Key details in this letter

  • 1FDA action: approval.
  • 2Application: NDA 016730.
  • 3Submission: supplement.
  • 4Sponsor: B BRAUN.

Suggested next step

Review the exact FDA letter for approved conditions, labeling, and postmarketing requirements.

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FDAPDFUpdated Jul 30, 2026

FDA source document

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Common questions about the DEXTROSE 5% IN PLASTIC CONTAINER approval letter

Is DEXTROSE 5% IN PLASTIC CONTAINER FDA approved?

This letter documents an FDA approval action: FDA approved NDA 016730 for DEXTROSE 5% IN PLASTIC CONTAINER, sponsored by B BRAUN, on May 13, 2026. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.

What is NDA 016730?

NDA 016730 is the application under which FDA issued this approval letter for DEXTROSE 5% IN PLASTIC CONTAINER to B BRAUN. The letter is dated May 13, 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.