FDA.reportPublic FDA data

Application 208114

Type
NDA
Sponsor
JAZZ PHARMS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DEFITELIODEFIBROTIDE SODIUMSOLUTION;INTRAVENOUS200MG/2.5ML (80MG/ML)YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
68727-800DEFITELIOdefibrotide sodiumJazz Pharmaceuticals, Inc.NDACurrent
68727-800DEFITELIOdefibrotide sodiumJazz Pharmaceuticals, Inc.NDACurrent
68727-800DEFITELIOdefibrotide sodiumJazz Pharmaceuticals, Inc.NDACurrent
68727-800DEFITELIOdefibrotide sodiumJazz Pharmaceuticals, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
43544ORIG2016-05-10
24533ORIG2016-05-10
32892ORIG2016-04-04
40617ORIG2016-03-30