FDA.reportPublic FDA data

Application 012209

Type
NDA
Sponsor
SPECTRUM PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FLUOROURACILFLUOROURACILINJECTABLE;INJECTION500MG/10ML (50MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
002FLUOROURACILFLUOROURACILINJECTABLE;INJECTION2.5GM/50ML (50MG/ML)YesNo

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
10798SUPPL2016-08-02
311SUPPL2016-08-02
20032SUPPL1999-01-20