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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 211413
Company: HQ SPCLT PHARMA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CEFAZOLIN SODIUM CEFAZOLIN SODIUM EQ 2GM BASE/VIAL POWDER;INTRAVENOUS Prescription None Yes Yes
CEFAZOLIN SODIUM CEFAZOLIN SODIUM EQ 3GM BASE/VIAL POWDER;INTRAVENOUS Prescription None Yes Yes

Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
05/08/2023 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/211413s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/211413Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2024/211413Orig1s000TOC.html
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/13/2026 SUPPL-3 Efficacy-New Dosing Regimen Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/211413s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/211413Orig1s003ltr.pdf
03/08/2024 SUPPL-1 Manufacturing (CMC)-New Strength Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/211413s001lbl.pdf

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
02/13/2026 SUPPL-3 Efficacy-New Dosing Regimen Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/211413s003lbl.pdf
03/08/2024 SUPPL-1 Manufacturing (CMC)-New Strength Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/211413s001lbl.pdf
05/08/2023 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/211413s000lbl.pdf
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