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Generated: April 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 050585

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NDA 050585 describes ROCEPHIN KIT, which is a drug marketed by Hoffmann La Roche and is included in one NDA. Additional details are available on the ROCEPHIN KIT profile page.

The generic ingredient in ROCEPHIN KIT is ceftriaxone sodium; lidocaine. There are twenty-four drug master file entries for this compound. Additional details are available on the ceftriaxone sodium; lidocaine profile page.
Summary for 050585
Tradename:ROCEPHIN KIT
Applicant:Hoffmann La Roche
Ingredient:ceftriaxone sodium; lidocaine
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INTRAMUSCULAR, INTRAVENOUSStrengthEQ 250MG BASE/VIAL
Approval Date:Dec 21, 1984TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INTRAMUSCULAR, INTRAVENOUSStrengthEQ 500MG BASE/VIAL
Approval Date:Dec 21, 1984TE:RLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INTRAMUSCULAR, INTRAVENOUSStrengthEQ 1GM BASE/VIAL
Approval Date:Dec 21, 1984TE:RLD:Yes

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