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US FDA source recordAL · Approval Letter

TEPADINA / TEPADINA AND SODIUM CHLORIDE — FDA Approval Letter (NDA 208264)

Issued to ADIENNE SA. Application is approved as submitted.

Issued

March 23, 2026

Application

NDA 505b1 • 208264

Product

TEPADINA / TEPADINA AND SODIUM CHLORIDE

Company

ADIENNE SA

Stage

Final Decision

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What did FDA decide for TEPADINA / TEPADINA AND SODIUM CHLORIDE?

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Source facts

FDA issued an approval letter for TEPADINA, TEPADINA AND SODIUM CHLORIDE on 2026-03-23. The source metadata identifies NDA 208264 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

Key details in this letter

  • 1FDA action: approval.
  • 2Application: NDA 208264.
  • 3Submission: supplement.
  • 4Sponsor: ADIENNE SA.

Suggested next step

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

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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

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Common questions about the TEPADINA / TEPADINA AND SODIUM CHLORIDE approval letter

Is TEPADINA / TEPADINA AND SODIUM CHLORIDE FDA approved?

This letter documents an FDA approval action: FDA approved NDA 208264 for TEPADINA / TEPADINA AND SODIUM CHLORIDE, sponsored by ADIENNE SA, on March 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 208264?

NDA 208264 is the application under which FDA issued this approval letter for TEPADINA / TEPADINA AND SODIUM CHLORIDE to ADIENNE SA. The letter is dated March 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.