Application 050624

Type
NDA
Sponsor
HOFFMANN LA ROCHE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ROCEPHIN W/ DEXTROSE IN PLASTIC CONTAINERCEFTRIAXONE SODIUMINJECTABLE;INJECTIONEQ 10MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
002ROCEPHIN W/ DEXTROSE IN PLASTIC CONTAINERCEFTRIAXONE SODIUMINJECTABLE;INJECTIONEQ 20MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
003ROCEPHIN W/ DEXTROSE IN PLASTIC CONTAINERCEFTRIAXONE SODIUMINJECTABLE;INJECTIONEQ 40MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
30180SUPPL2004-09-15
17939SUPPL2004-09-15
39046SUPPL2004-09-03
7894SUPPL2004-09-03