FDA.reportPublic FDA data

Application 101063

Type
BLA
Sponsor
MERCK

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
101063Elsparasparaginase351(a)Disc2026-07-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ELSPARASPARAGINASEVIAL10,000IU/VIALNoNo

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
31547SUPPL2013-07-18
39621SUPPL2013-07-17
39620SUPPL2007-04-20
31546SUPPL2007-04-20
9354SUPPL2006-07-25
18546SUPPL2006-07-21
9353SUPPL2004-07-07
18545SUPPL2004-03-12
9352SUPPL2004-03-12