FDA.reportPublic FDA data

Application 761188

Type
BLA
Sponsor
BIOCON BIOLOGICS INC

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761188Kirstyinsulin aspart-xjhz351(k) InterchangeableRx2026-06-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001KIRSTYINSULIN ASPART-XJHZINJECTION;SOLUTION100 UNITS/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 ยท 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
INSULIN DILUTING MEDIUM FOR KirstyWATERBiocon Biologics Inc.3db1d482-7e1f-aec6-79ef-3f305b4d82772026-01-20Warnings, Adverse reactionsExact identifier
application number: BLA761188

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
82876ORIG 2025-07-15
82869ORIG 2025-07-15