FDA.reportPublic FDA data

Application 018310

Type
NDA
Sponsor
COVIDIEN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LYMPHAZURINISOSULFAN BLUEINJECTABLE;INJECTION1% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
63261-250LYMPHAZURINisosulfan blueUNITED STATES SURGICAL CORPORATIONNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
14978SUPPL2007-11-08
11203SUPPL2007-11-07