Skip to content
Assyro AI
US FDA source recordAL · Approval Letter

POTASSIUM CHLORIDE 0.037% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER / POTASSIUM CHLORIDE 0.075% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER / POTASSIUM CHLORIDE 0.11% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER — FDA Approval Letter (NDA 019708)

Issued to B BRAUN. Application is approved as submitted.

Issued

January 22, 2026

Application

NDA 505b1 • 019708

Product

POTASSIUM CHLORIDE 0.037% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER / POTASSIUM CHLORIDE 0.075% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER / POTASSIUM CHLORIDE 0.11% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Company

B BRAUN

Stage

Final Decision

Read source documentView similar AL records

Assyro regulatory brief

Free

What did FDA decide for POTASSIUM CHLORIDE 0.037% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER / POTASSIUM CHLORIDE 0.075% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER / POTASSIUM CHLORIDE 0.11% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER?

Source facts and Assyro context are separated so you can scan the action quickly without treating analysis as an FDA conclusion.

Verify in source

Source facts

FDA issued an approval letter for POTASSIUM CHLORIDE 0.037% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, POTASSIUM CHLORIDE 0.075% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, POTASSIUM CHLORIDE 0.11% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER on 2026-01-22. The source metadata identifies NDA 019708 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

Key details in this letter

  • 1FDA action: approval.
  • 2Application: NDA 019708.
  • 3Submission: supplement.
  • 4Sponsor: B BRAUN.

Suggested next step

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

Open the document workspace

Built from structured FDA metadata and deterministic source-text signals. Topic matches are navigation aids, not legal or regulatory conclusions. Verify material decisions against the original FDA document.

FDAPDFUpdated Jul 30, 2026

FDA source document

Read the full FDA approval letter (PDF)

Loading document viewer…

Common questions about the POTASSIUM CHLORIDE 0.037% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER / POTASSIUM CHLORIDE 0.075% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER / POTASSIUM CHLORIDE 0.11% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER approval letter

Is POTASSIUM CHLORIDE 0.037% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER / POTASSIUM CHLORIDE 0.075% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER / POTASSIUM CHLORIDE 0.11% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER FDA approved?

This letter documents an FDA approval action: FDA approved NDA 019708 for POTASSIUM CHLORIDE 0.037% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER / POTASSIUM CHLORIDE 0.075% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER / POTASSIUM CHLORIDE 0.11% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, sponsored by B BRAUN, on January 22, 2026. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.

What is NDA 019708?

NDA 019708 is the application under which FDA issued this approval letter for POTASSIUM CHLORIDE 0.037% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER / POTASSIUM CHLORIDE 0.075% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER / POTASSIUM CHLORIDE 0.11% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER to B BRAUN. The letter is dated January 22, 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.