Data updated: Mar 10, 2026
CEFAZOLIN SODIUM
CEFAZOLIN SODIUM
Approved 1988-01-12
24
Indications
--
Phase 3 Trials
38
Years on Market
Details
- Status
- Discontinued
- First Approved
- 1988-01-12
- Routes
- INJECTION, INTRAVENOUS
- Dosage Forms
- INJECTABLE, POWDER
Companies
ABRAXIS PHARM Hikma Dr. Reddy's STERI PHARMA FACTA FARMA Pfizer CEPHAZONE PHARMA Aurobindo Pharma QILU ANTIBIOTICS HQ SPCLT PHARMA Fresenius Kabi Novartis SAMSON MEDCL Teva GSK ACS DOBFAR BEDFORD
Active Ingredient: CEFAZOLIN SODIUM
Website: ↗
CEFAZOLIN SODIUM Approval History
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What CEFAZOLIN SODIUM Treats
24 FDA approvalsOriginally approved for its first indication in 1988 . Covers 24 distinct patient populations.
- Other (24)
Other
(24 approvals)- • Approved indication (Jan 1988)
- • Approved indication (Dec 1988)
- • Approved indication (Mar 1989)
- • Approved indication (Dec 1989)
- • Approved indication (Dec 1991)
- • Approved indication (Oct 1993)
- • Approved indication (Mar 1998)
- • Approved indication (Aug 1998)Letter
- • Approved indication (Sep 2001)Letter
- • Approved indication (Oct 2004)
- • Approved indication (Apr 2005)
- • Approved indication (Aug 2005)
- • Approved indication (Nov 2006)
- • Approved indication (May 2007)
- • Approved indication (Aug 2008)
- • Approved indication (Oct 2008)
- • Approved indication (Mar 2009)
- • Approved indication (Dec 2015)
- • Approved indication (Feb 2016)
- • Approved indication (Oct 2018)
- • Approved indication (Oct 2022)Label Letter
- • Approved indication (May 2023)Label Letter
- • Approved indication (Dec 2024)Label Letter
- • Approved indication (Feb 2026) NewLabel Letter
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
Full development history with FDA approval milestones
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Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
CEFAZOLIN SODIUM FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.