FDA.reportPublic FDA data

Application 021271

Type
BLA
Sponsor
BAUSCH

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
021271Iprivaskdesirudin351(a)Disc2026-06-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001IPRIVASKDESIRUDIN RECOMBINANTINJECTABLE;SUBCUTANEOUS15MG/VIALNoNo

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
62258APPL2020-03-23
42067ORIG2020-03-23
27303ORIG2020-03-23
14820SUPPL2020-03-23
14819ORIG2020-03-23
4854SUPPL2020-03-23