Source facts
FDA issued an approval letter for CEFAZOLIN SODIUM on 2026-02-18. The source metadata identifies NDA 211413 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
US FDA source recordAL · Approval Letter
CEFAZOLIN SODIUM — FDA Approval Letter (NDA 211413)
Issued to HQ SPCLT PHARMA. Application is approved as submitted.
Issued
February 18, 2026Application
NDA 505b1 • 211413
Product
CEFAZOLIN SODIUM
Company
HQ SPCLT PHARMA
Stage
Final Decision
Assyro regulatory brief
FreeWhat did FDA decide for CEFAZOLIN SODIUM?
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Key details in this letter
- 1FDA action: approval.
- 2Application: NDA 211413.
- 3Submission: supplement.
- 4Sponsor: HQ SPCLT PHARMA.
Suggested next step
Review the exact FDA letter for approved conditions, labeling, and postmarketing requirements.
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Common questions about the CEFAZOLIN SODIUM approval letter
Is CEFAZOLIN SODIUM FDA approved?
This letter documents an FDA approval action: FDA approved NDA 211413 for CEFAZOLIN SODIUM, sponsored by HQ SPCLT PHARMA, on February 18, 2026. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.
What is NDA 211413?
NDA 211413 is the application under which FDA issued this approval letter for CEFAZOLIN SODIUM to HQ SPCLT PHARMA. The letter is dated February 18, 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.