Source facts
FDA issued an approval letter for SYMBICORT AEROSPHERE on 2026-05-01. The source metadata identifies NDA 216579 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
US FDA source recordAL · Approval Letter
SYMBICORT AEROSPHERE — FDA Approval Letter (NDA 216579)
Issued to ASTRAZENECA. Application is approved as submitted.
Issued
May 1, 2026Application
NDA 505b1 • 216579
Product
SYMBICORT AEROSPHERE
Company
ASTRAZENECA
Stage
Final Decision
Assyro regulatory brief
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Key details in this letter
- 1FDA action: approval.
- 2Application: NDA 216579.
- 3Submission: supplement.
- 4Sponsor: ASTRAZENECA.
Suggested next step
Review the exact FDA letter for approved conditions, labeling, and postmarketing requirements.
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Common questions about the SYMBICORT AEROSPHERE approval letter
Is SYMBICORT AEROSPHERE FDA approved?
This letter documents an FDA approval action: FDA approved NDA 216579 for SYMBICORT AEROSPHERE, sponsored by ASTRAZENECA, on May 1, 2026. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.
What is NDA 216579?
NDA 216579 is the application under which FDA issued this approval letter for SYMBICORT AEROSPHERE to ASTRAZENECA. The letter is dated May 1, 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.