Source facts
FDA issued an approval letter for AIR on 2026-02-20. The source metadata identifies NDA 221287 as an original application. Review the exact FDA letter for the approved conditions and labeling.
US FDA source recordAL · Approval Letter
AIR — FDA Approval Letter (NDA 221287)
Issued to GENERAL AIR SERVICE & SUPPLY COMPANY. Application is approved as submitted.
Issued
February 20, 2026Application
NDA 505b1 • 221287
Product
AIR
Company
GENERAL AIR SERVICE & SUPPLY COMPANY
Stage
Final Decision
Assyro regulatory brief
FreeWhat did FDA decide for AIR?
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 221287.
- 3Submission: original application.
- 4Sponsor: GENERAL AIR SERVICE & SUPPLY COMPANY.
Suggested next step
Review the exact FDA letter for approved conditions, labeling, and postmarketing requirements.
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Common questions about the AIR approval letter
Is AIR FDA approved?
This letter documents an FDA approval action: FDA approved NDA 221287 for AIR, sponsored by GENERAL AIR SERVICE & SUPPLY COMPANY, on February 20, 2026. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.
What is NDA 221287?
NDA 221287 is the application under which FDA issued this approval letter for AIR to GENERAL AIR SERVICE & SUPPLY COMPANY. The letter is dated February 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.