Issued to US ANTIBIOTICS. Application is approved as submitted.
Issued
July 21, 2026Application
NDA 505b1 • 050575
Product
AUGMENTIN '125' / AUGMENTIN '250' / AUGMENTIN '200'
Company
US ANTIBIOTICS
Stage
Final Decision
Assyro regulatory brief
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FDA issued an approval letter for AUGMENTIN '125', AUGMENTIN '250', AUGMENTIN '200' on 2026-07-21. The source metadata identifies NDA 050575, NDA 050726, NDA 050785, NDA 050597, NDA 050720, NDA 050755, NDA 050725, NDA 050564 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 050575 for AUGMENTIN '125' / AUGMENTIN '250' / AUGMENTIN '200', sponsored by US ANTIBIOTICS, on July 21, 2026. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.
NDA 050575 is the application under which FDA issued this approval letter for AUGMENTIN '125' / AUGMENTIN '250' / AUGMENTIN '200' to US ANTIBIOTICS. The letter is dated July 21, 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.