FDA.reportPublic FDA data

Application 761102

Type
BLA
Sponsor
SERVIER PHARMA LLC

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761102Asparlascalaspargase pegol-mknl351(a)Rx2026-09-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ASPARLASCALASPARGASE PEGOL-MKNLINJECTABLE;INTRAVENOUS3750UNITS/5MLNoNo

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
asparlasCALASPARGASE PEGOLServier Pharmaceuticals LLC6585bd0d-bd78-4341-9e87-0f7664821f052024-10-08Warnings, Adverse reactionsExact identifier
application number: BLA761102
ndc (product): 72694-515

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
72694-515asparlascalaspargase pegolServier Pharmaceuticals LLCBLACurrent
72694-515asparlascalaspargase pegolServier Pharmaceuticals LLCBLACurrent
72694-515asparlascalaspargase pegolServier Pharmaceuticals LLCBLACurrent
72694-515asparlascalaspargase pegolServier Pharmaceuticals LLCBLACurrent
72694-515asparlascalaspargase pegolServier Pharmaceuticals LLCBLACurrent
72694-515asparlascalaspargase pegolServier Pharmaceuticals LLCBLACurrent
72694-515asparlascalaspargase pegolServier Pharmaceuticals LLCBLACurrent
72694-515asparlascalaspargase pegolServier Pharmaceuticals LLCBLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76703SUPPL 2023-11-30
76699SUPPL 2023-11-29
69753SUPPL2021-12-23
69742SUPPL2021-12-22
63705SUPPL2020-06-25
63696SUPPL2020-06-25
59922SUPPL2019-09-06
59921SUPPL2019-09-05
57292ORIG2019-01-22
56958ORIG2018-12-21
56832ORIG2018-12-20