Source facts
FDA issued an approval letter for ARGATROBAN IN 0.9% SODIUM CHLORIDE on 2026-06-30. The source metadata identifies NDA 206769 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
US FDA source recordAL · Approval Letter
ARGATROBAN IN 0.9% SODIUM CHLORIDE — FDA Approval Letter (NDA 206769)
Issued to TEVA PHARMS USA. Application is approved as submitted.
Issued
June 30, 2026Application
NDA 505b1 • 206769
Product
ARGATROBAN IN 0.9% SODIUM CHLORIDE
Company
TEVA PHARMS USA
Stage
Final Decision
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Key details in this letter
- 1FDA action: approval.
- 2Application: NDA 206769.
- 3Submission: supplement.
- 4Sponsor: TEVA PHARMS USA.
Suggested next step
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Common questions about the ARGATROBAN IN 0.9% SODIUM CHLORIDE approval letter
Is ARGATROBAN IN 0.9% SODIUM CHLORIDE FDA approved?
This letter documents an FDA approval action: FDA approved NDA 206769 for ARGATROBAN IN 0.9% SODIUM CHLORIDE, sponsored by TEVA PHARMS USA, on June 30, 2026. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.
What is NDA 206769?
NDA 206769 is the application under which FDA issued this approval letter for ARGATROBAN IN 0.9% SODIUM CHLORIDE to TEVA PHARMS USA. The letter is dated June 30, 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.