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US FDA source recordAL · Approval Letter

FLUTICASONE PROPIONATE — FDA Approval Letter (ANDA 219602)

Issued to GLENMARK SPECLT. Application is approved as submitted.

Issued

March 20, 2026

Application

ANDA 505j • 219602

Product

FLUTICASONE PROPIONATE

Company

GLENMARK SPECLT

Stage

Final Decision

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What did FDA decide for FLUTICASONE PROPIONATE?

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Source facts

FDA issued an approval letter for FLUTICASONE PROPIONATE on 2026-03-20. The source metadata identifies ANDA 219602 as an original application. Review the exact FDA letter for the approved conditions and labeling.

Key details in this letter

  • 1FDA action: approval.
  • 2Application: ANDA 219602.
  • 3Submission: original application.
  • 4Sponsor: GLENMARK SPECLT.

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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 FLUTICASONE PROPIONATE approval letter

Is FLUTICASONE PROPIONATE FDA approved?

This letter documents an FDA approval action: FDA approved ANDA 219602 for FLUTICASONE PROPIONATE, sponsored by GLENMARK SPECLT, on March 20, 2026. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.

What is ANDA 219602?

ANDA 219602 is the application under which FDA issued this approval letter for FLUTICASONE PROPIONATE to GLENMARK SPECLT. The letter is dated March 20, 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.