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TIVOZANIB — FDA Tentative Approval Letter (ANDA 220437)

Issued to SANDOZ INC. Application meets requirements but marketing is blocked (patent/exclusivity).

Issued

July 21, 2026

Application

ANDA 505j • 220437

Product

TIVOZANIB

Company

SANDOZ INC

Stage

Final Decision

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What did FDA decide for TIVOZANIB?

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Source facts

FDA issued a tentative approval letter for TIVOZANIB on 2026-07-21. The source metadata identifies ANDA 220437 as an original application. Review the exact FDA letter for the approved conditions and labeling.

Key details in this letter

  • 1FDA action: tentative approval.
  • 2Application: ANDA 220437.
  • 3Submission: original application.
  • 4Sponsor: SANDOZ INC.

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

Read the full FDA tentative approval letter (PDF)

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Common questions about the TIVOZANIB tentative approval letter

Is TIVOZANIB FDA approved?

Not for marketing yet. FDA granted tentative approval to ANDA 220437 for TIVOZANIB on July 21, 2026, meaning the application meets approval standards but patent or exclusivity protections block final approval. The product cannot be marketed until those conditions resolve and FDA issues final approval.

What is ANDA 220437?

ANDA 220437 is the application under which FDA issued this tentative approval letter for TIVOZANIB to SANDOZ INC. The letter is dated July 21, 2026.

What happens after an FDA tentative approval letter?

The product cannot be marketed yet. Tentative approval means the application meets FDA approval standards, but patent or exclusivity protections block final approval. The sponsor typically requests final approval as the blocking date approaches, and FDA re-verifies that the approval conditions still hold before granting it.