Application 761240

Type
BLA
Sponsor
COHERUS BIOSCIENCES INC

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761240Loqtorzitoripalimab-tpzi351(a)Rx2026-09-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LOQTORZITORIPALIMAB-TPZIINJECTABLE;INJECTION240MG/6ML(40MG/ML)NoNo

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 ยท 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LOQTORZITORIPALIMAB-TPZICoherus Oncology, Inc.82e7921a-1e84-4988-9799-0ad7d19b2a752026-07-23Warnings, Adverse reactionsExact identifier
application number: BLA761240

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
80063SUPPL 2024-11-01
80062SUPPL 2024-11-01
78251SUPPL 2024-04-25
78210SUPPL 2024-04-23
76718ORIG 2023-12-04
75985ORIG 2023-10-30
75982ORIG 2023-10-30
75981ORIG 2023-10-30