Issued to TAKEDA PHARMS USA. Application is approved as submitted.
Issued
April 27, 2026Application
NDA 505b1 • 021303
Product
ADDERALL XR 10 / ADDERALL XR 20 / ADDERALL XR 30
Company
TAKEDA PHARMS USA
Stage
Final Decision
Assyro regulatory brief
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FDA issued an approval letter for ADDERALL XR 10, ADDERALL XR 20, ADDERALL XR 30 on 2026-04-27. The source metadata identifies NDA 021303, NDA 021977, NDA 022063, NDA 208510 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Review the exact FDA letter for approved conditions, labeling, and postmarketing requirements.
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This letter documents an FDA approval action: FDA approved NDA 021303 for ADDERALL XR 10 / ADDERALL XR 20 / ADDERALL XR 30, sponsored by TAKEDA PHARMS USA, on April 27, 2026. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.
NDA 021303 is the application under which FDA issued this approval letter for ADDERALL XR 10 / ADDERALL XR 20 / ADDERALL XR 30 to TAKEDA PHARMS USA. The letter is dated April 27, 2026.
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.