FDA.reportPublic FDA data

Application 209472

Type
NDA
Sponsor
EAGLE PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PEMFEXYPEMETREXEDSOLUTION;INTRAVENOUS500MG/20ML (25MG/ML)YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
42367-531PemfexypemetrexedEagle Pharmaceuticals, Inc.NDACurrent
42367-531PemfexypemetrexedEagle Pharmaceuticals, Inc.NDACurrent
42367-531PemfexypemetrexedEagle Pharmaceuticals, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
72919SUPPL2022-12-19
72894SUPPL2022-12-15
70179SUPPL2022-02-16
64583ORIG2020-09-16
63610SUPPL2020-06-18
61852ORIG2020-02-10
61850ORIG2020-02-10