FDA.reportPublic FDA data

Application 021884

Type
BLA
Sponsor
INSMED

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
021884Iplexmecasermin rinfabate351(a)Disc2026-09-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001IPLEXMECASERMIN RINFABATE RECOMBINANTINJECTABLE;SUBCUTANEOUS36MG/0.6MLNoNo

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
42337SUPPL2020-03-23
37829SUPPL2020-03-23
37828ORIG2020-03-23
28785SUPPL2020-03-23
21859ORIG2020-03-23
6387SUPPL2020-03-23
6386ORIG2020-03-23
66384APPL2020-03-22