FDA.reportPublic FDA data

Application 020304

Type
BLA
Sponsor
BAYER HLTHCARE

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
020304Trasylolaprotinin351(a)Disc2026-06-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TRASYLOLAPROTINININJECTABLE;INJECTION10,000KIU/MLNoNo

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
62236APPL2020-03-23
44055ORIG2020-03-23
24756SUPPL2020-03-23
20591SUPPL2020-03-23
12432SUPPL2020-03-23
12431SUPPL2020-03-23
12430SUPPL2020-03-23
2319SUPPL2020-03-23