Application 125547

Type
BLA
Sponsor
ELI LILLY CO

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125547Portrazzanecitumumab351(a)Rx2026-06-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PORTRAZZANECITUMUMABINJECTABLE;INTRA-ARTICULAR, INTRAMUSCULAR, INTRAVITREAL800MG/50MLYesNo

NDC Listings For This Application#

NDC listings for this application page 1 of 1 ยท 1 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0002-7716PortrazzanecitumumabEli Lilly and CompanyBLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
44817ORIG2015-12-30
43337ORIG2015-12-30
39989ORIG2015-11-24
9781ORIG2015-11-24