Kirsty Purple Book BLA 761188

BLA number: 761188
Proprietary names: Kirsty
Proper names: insulin aspart-xjhz
Applicant: Biocon Biologics Inc.
Center: CDER
First observed release: 2025-07-01
Latest observed release: 2026-06-01
Newest archive release: 2026-06-01
FDA patent list: No patents listed in the captured FDA patent list; source updated 2025-06-11
Coverage: Present in newest release

Latest Known Product Presentations#

Product, Proprietary name, Proper name table
Product	Proprietary name	Proper name	License type	Strength	Dosage form	Route	Presentation	Marketing	Licensure	Approval	Patent list provided
001	Kirsty	insulin aspart-xjhz	351(k) Interchangeable	300UNITS/3ML (100UNITS/ML)	Injection	Subcutaneous	Autoinjector	Rx	Licensed	2025-07-15
002	Kirsty	insulin aspart-xjhz	351(k) Interchangeable	1,000UNITS/10ML (100UNITS/ML)	Injection	Intravenous, Subcutaneous	Multi-Dose Vial	Rx	Licensed	2025-07-15

Reference Biological Product#

BLA, Proprietary name, Proper name table
BLA	Proprietary name	Proper name	License type	Status	Latest source
020986	Novolog	insulin aspart	351(a)	Rx	2026-06-01

Published Patent List#

No patents for this BLA were listed in the FDA Purple Book patent list captured from the source updated 2025-06-11.

NDC, Proprietary name, Nonproprietary name table
NDC	Proprietary name	Nonproprietary name	Labeler	Source
83257-006	INSULIN DILUTING MEDIUM FOR Kirsty	water	Biocon Biologics Inc.	current
83257-007	KIRSTY	insulin aspart-xjhz	Biocon Biologics Inc.	current
83257-008	KIRSTY	insulin aspart-xjhz	Biocon Biologics Inc.	current

Label, Manufacturer, Effective table
Label	Manufacturer	Effective
KIRSTY	Biocon Biologics Inc. \| BIOCON SDN.BHD.	2026-01-20
KIRSTY	Biocon Biologics Inc. \| BIOCON SDN.BHD.	2025-08-20
KIRSTY	Biocon Biologics Inc. \| BIOCON SDN.BHD.	2025-08-20

Official Monthly Change Events#

Release, Event, Product table
Release	Event	Product	Name	License type	Status	Applicant
2026-05-01	U	001	Kirsty	351(k) Interchangeable	Rx	Biocon Biologics Inc.
2026-05-01	U	002	Kirsty	351(k) Interchangeable	Rx	Biocon Biologics Inc.
2025-07-01	N	001	Kirsty	351(k) Interchangeable	Rx	Biocon Biologics Inc.
2025-07-01	N	002	Kirsty	351(k) Interchangeable	Rx	Biocon Biologics Inc.

Observed Product State History#

Release, Product, Name table
Release	Product	Name	License type	Marketing	Licensure	Approval
2025-07-01	001	Kirsty	351(k) Interchangeable	Rx	Licensed	2025-07-15
2025-07-01	002	Kirsty	351(k) Interchangeable	Rx	Licensed	2025-07-15