Last Updated: November 8, 2026

Details for New Drug Application (NDA): 050547

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NDA 050547 describes CLAFORAN, which is a drug marketed by Sanofi Aventis Us and Sterimax and is included in three NDAs. It is available from one supplier. Additional details are available on the CLAFORAN profile page.

The generic ingredient in CLAFORAN is cefotaxime sodium. There is one drug master file entry for this compound. Two suppliers are listed for this compound. Additional details are available on the cefotaxime sodium profile page.
Summary for 050547
Tradename:CLAFORAN
Applicant:Sterimax
Ingredient:cefotaxime sodium
Patents:0
Pharmacology for NDA: 050547
Medical Subject Heading (MeSH) Categories for 050547
Anti-Bacterial Agents
Suppliers and Packaging for NDA: 050547
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CLAFORAN cefotaxime sodium INJECTABLE;INJECTION 050547 NDA SteriMax Inc. 21586-031 21586-031-02 10 VIAL in 1 CARTON (21586-031-02) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (21586-031-01)

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrengthEQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrengthEQ 2GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes

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Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2026, www.DrugPatentWatch.com.
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