Last Updated: November 13, 2026

Details for New Drug Application (NDA): 050624

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NDA 050624 describes ROCEPHIN W/ DEXTROSE IN PLASTIC CONTAINER, which is a drug marketed by Hoffmann La Roche and is included in one NDA. Additional details are available on the ROCEPHIN W/ DEXTROSE IN PLASTIC CONTAINER profile page.

The generic ingredient in ROCEPHIN W/ DEXTROSE IN PLASTIC CONTAINER is ceftriaxone sodium. There is one drug master file entry for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the ceftriaxone sodium profile page.
Summary for 050624
Tradename:ROCEPHIN W/ DEXTROSE IN PLASTIC CONTAINER
Applicant:Hoffmann La Roche
Ingredient:ceftriaxone sodium
Patents:0
Medical Subject Heading (MeSH) Categories for 050624
Anti-Bacterial Agents

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrengthEQ 10MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Feb 11, 1987TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrengthEQ 20MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Feb 11, 1987TE:RLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrengthEQ 40MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Feb 11, 1987TE:RLD:Yes

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