Purple Book product · Interchangeable
Kirsty
insulin aspart-xjhz
At a glance
Jul 15, 2025
Approved
Interchangeable
License type
Rx
Marketing
No
Patents listed
Key dates
Approval
Approval date of this BLA submission.
Jul 15, 2025
11 mo ago
Today
Pharmaceutical detail
Strength
1,000UNITS/10ML (100UNITS/ML)
Dosage form
Injection
Route
Intravenous, Subcutaneous
Presentation
Multi-Dose Vial
Center
CDER
License number
2324
Product number
002
Submission type
Original
Supplement number
Not listed
Change type
Not listed
Reference product family
View full familyBiosimilar of insulin aspart (Novolog)
- 2017FiaspReference 351(a)
insulin aspart · Novo Nordisk Inc.
- 2000NovologReference 351(a)
insulin aspart · Novo Nordisk Inc.
- 2000NovologReference 351(a)
insulin aspart · Novo Nordisk Inc.
- 2017FiaspReference 351(a)
insulin aspart · Novo Nordisk Inc.
- 2018FiaspReference 351(a)
insulin aspart · Novo Nordisk Inc.
- 2001NovologReference 351(a)
insulin aspart · Novo Nordisk Inc.
- 2023FiaspReference 351(a)
insulin aspart · Novo Nordisk Inc.
- 2004NovologReference 351(a)
insulin aspart · Novo Nordisk Inc.
- 2013NovologReference 351(a)
insulin aspart · Novo Nordisk Inc.
- 2025KirstyInterchangeable
insulin aspart-xjhz · Biocon Biologics Inc.
Patent list
No patent-list records were published for this product. The Purple Book patent list reflects the statutory patent exchange under the BPCIA and is not exhaustive.
Taxonomy and ontology
10 termscenter
Center for Drug Evaluation and Research
center · CDER
application pathway
Biologics License Application
blaNumber · BLA
license type
351(k) Interchangeable
blaType · 351(k) Interchangeable
application pathway
Section 351(k) Biosimilar or Interchangeable
blaType · 351(k)
product role
Interchangeable Biologic
blaType · Interchangeable
marketing status
Prescription
marketingStatus · Rx
licensure status
Licensed
licensure · Licensed
dosage form
Injection
dosageForm · Injection
source kind
Monthly Download
sourceKind · monthly_download
patent status
No Patent List Provided
patentListProvided · No patent list
- Food and Drug Administrationparent ofCenter for Drug Evaluation and Research
- Food and Drug Administrationsource forMonthly Download
- Biologics License Applicationparent ofSection 351(a) Biologic
- Biologics License Applicationparent ofSection 351(k) Biosimilar or Interchangeable
- Section 351(k) Biosimilar or Interchangeablemaps to351(k) Biosimilar
- Section 351(k) Biosimilar or Interchangeablemaps to351(k) Interchangeable
Source provenance
