Source facts
FDA issued an approval letter for CEPHALEXIN on 2026-06-11. The source metadata identifies ANDA 213568 as an original application. Review the exact FDA letter for the approved conditions and labeling.
US FDA source recordAL · Approval Letter
CEPHALEXIN — FDA Approval Letter (ANDA 213568)
Issued to AUROBINDO PHARMA. Application is approved as submitted.
Issued
June 11, 2026Application
ANDA 505j • 213568
Product
CEPHALEXIN
Company
AUROBINDO PHARMA
Stage
Final Decision
Assyro regulatory brief
FreeWhat did FDA decide for CEPHALEXIN?
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Key details in this letter
- 1FDA action: approval.
- 2Application: ANDA 213568.
- 3Submission: original application.
- 4Sponsor: AUROBINDO PHARMA.
Suggested next step
Review the exact FDA letter for approved conditions, labeling, and postmarketing requirements.
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Common questions about the CEPHALEXIN approval letter
Is CEPHALEXIN FDA approved?
This letter documents an FDA approval action: FDA approved ANDA 213568 for CEPHALEXIN, sponsored by AUROBINDO PHARMA, on June 11, 2026. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.
What is ANDA 213568?
ANDA 213568 is the application under which FDA issued this approval letter for CEPHALEXIN to AUROBINDO PHARMA. The letter is dated June 11, 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.