Application 761336

Type
BLA
Sponsor
ALTOR BIOSCIENCE, LLC, AN INDIRECT WHOLLY-OWNED SU

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761336Anktivanogapendekin alfa inbakicept-pmln351(a)Rx2026-07-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ANKTIVAnogapendekin alfa inbakicept-pmlnSOLUTION;INTRAVESICAL400mcg/0.4 mLNoNo

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
ANKTIVANOGAPENDEKIN ALFA INBAKICEPT-PMLNAltor BioScience, LLC, an indirect wholly-owned subsidiary of ImmunityBio, Inc.eae31db8-3e7a-d9e0-708d-74419d1b50ff2025-06-24Warnings, Adverse reactionsExact identifier
application number: BLA761336

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
78539ORIG 2024-05-22
78211ORIG 2024-04-23
78202ORIG 2024-04-22