Source facts
FDA issued an approval letter for MEDICAL AIR, USP on 2026-03-16. The source metadata identifies NDA 221337 as an original application. Review the exact FDA letter for the approved conditions and labeling.
US FDA source recordAL · Approval Letter
MEDICAL AIR, USP — FDA Approval Letter (NDA 221337)
Issued to INDUSTRIAL WELDING SUPPLY CO OF HARVEY INC. Application is approved as submitted.
Issued
March 16, 2026Application
NDA 505b1 • 221337
Product
MEDICAL AIR, USP
Company
INDUSTRIAL WELDING SUPPLY CO OF HARVEY INC
Stage
Final Decision
Assyro regulatory brief
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Key details in this letter
- 1FDA action: approval.
- 2Application: NDA 221337.
- 3Submission: original application.
- 4Sponsor: INDUSTRIAL WELDING SUPPLY CO OF HARVEY INC.
Suggested next step
Review the exact FDA letter for approved conditions, labeling, and postmarketing requirements.
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Common questions about the MEDICAL AIR, USP approval letter
Is MEDICAL AIR, USP FDA approved?
This letter documents an FDA approval action: FDA approved NDA 221337 for MEDICAL AIR, USP, sponsored by INDUSTRIAL WELDING SUPPLY CO OF HARVEY INC, on March 16, 2026. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.
What is NDA 221337?
NDA 221337 is the application under which FDA issued this approval letter for MEDICAL AIR, USP to INDUSTRIAL WELDING SUPPLY CO OF HARVEY INC. The letter is dated March 16, 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.