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US FDA source recordAL · Approval Letter

ARGATROBAN IN SODIUM CHLORIDE — FDA Approval Letter (NDA 212035)

Issued to ACCORD HLTHCARE. Application is approved as submitted.

Issued

May 26, 2026

Application

NDA 505b1 • 212035

Product

ARGATROBAN IN SODIUM CHLORIDE

Company

ACCORD HLTHCARE

Stage

Final Decision

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What did FDA decide for ARGATROBAN IN SODIUM CHLORIDE?

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Source facts

FDA issued an approval letter for ARGATROBAN IN SODIUM CHLORIDE on 2026-05-26. The source metadata identifies NDA 212035 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

Key details in this letter

  • 1FDA action: approval.
  • 2Application: NDA 212035.
  • 3Submission: supplement.
  • 4Sponsor: ACCORD HLTHCARE.

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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 ARGATROBAN IN SODIUM CHLORIDE approval letter

Is ARGATROBAN IN SODIUM CHLORIDE FDA approved?

This letter documents an FDA approval action: FDA approved NDA 212035 for ARGATROBAN IN SODIUM CHLORIDE, sponsored by ACCORD HLTHCARE, on May 26, 2026. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.

What is NDA 212035?

NDA 212035 is the application under which FDA issued this approval letter for ARGATROBAN IN SODIUM CHLORIDE to ACCORD HLTHCARE. The letter is dated May 26, 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.