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US FDA source recordAL · Approval Letter

AK-FLUOR 10% / AK-FLUOR 25% — FDA Approval Letter (NDA 022186)

Issued to LONG GROVE PHARMS. Application is approved as submitted.

Issued

March 25, 2026

Application

NDA 505b1 • 022186

Product

AK-FLUOR 10% / AK-FLUOR 25%

Company

LONG GROVE PHARMS

Stage

Final Decision

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What did FDA decide for AK-FLUOR 10% / AK-FLUOR 25%?

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Source facts

FDA issued an approval letter for AK-FLUOR 10%, AK-FLUOR 25% on 2026-03-25. The source metadata identifies NDA 022186 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

Key details in this letter

  • 1FDA action: approval.
  • 2Application: NDA 022186.
  • 3Submission: supplement.
  • 4Sponsor: LONG GROVE PHARMS.

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

FDA source document

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Common questions about the AK-FLUOR 10% / AK-FLUOR 25% approval letter

Is AK-FLUOR 10% / AK-FLUOR 25% FDA approved?

This letter documents an FDA approval action: FDA approved NDA 022186 for AK-FLUOR 10% / AK-FLUOR 25%, sponsored by LONG GROVE PHARMS, on March 25, 2026. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.

What is NDA 022186?

NDA 022186 is the application under which FDA issued this approval letter for AK-FLUOR 10% / AK-FLUOR 25% to LONG GROVE PHARMS. The letter is dated March 25, 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.