Source facts
FDA issued an approval letter for ARGATROBAN on 2026-05-19. The source metadata identifies NDA 203049 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
US FDA source recordAL · Approval Letter
ARGATROBAN — FDA Approval Letter (NDA 203049)
Issued to HIKMA PHARM CO LTD. Application is approved as submitted.
Issued
May 19, 2026Application
NDA 505b1 • 203049
Product
ARGATROBAN
Company
HIKMA PHARM CO LTD
Stage
Final Decision
Assyro regulatory brief
FreeWhat did FDA decide for ARGATROBAN?
Source facts and Assyro context are separated so you can scan the action quickly without treating analysis as an FDA conclusion.
Key details in this letter
- 1FDA action: approval.
- 2Application: NDA 203049.
- 3Submission: supplement.
- 4Sponsor: HIKMA PHARM CO LTD.
Suggested next step
Review the exact FDA letter for approved conditions, labeling, and postmarketing requirements.
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Common questions about the ARGATROBAN approval letter
Is ARGATROBAN FDA approved?
This letter documents an FDA approval action: FDA approved NDA 203049 for ARGATROBAN, sponsored by HIKMA PHARM CO LTD, on May 19, 2026. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.
What is NDA 203049?
NDA 203049 is the application under which FDA issued this approval letter for ARGATROBAN to HIKMA PHARM CO LTD. The letter is dated May 19, 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.