Purple Book product · Reference 351(a)

Fiasp

insulin aspart

351(a)BLA 208751RxLicensed Novo Nordisk Inc.

View insulin aspart family Label PDF Open on FDA Purple Book

Jun 21, 2023

Approved

Reference 351(a)

License type

Marketing

None

Listed patents

Fiasp (insulin aspart) is Novo Nordisk Inc.'s FDA-licensed reference biologic, approved under a 351(a) BLA in 2023. 2 approved follow-on biologics reference Fiasp (Merilog and Kirsty).

Sourced from the FDA Purple Book · verified Jul 02, 2026

Key dates

Approval
Approval date of this BLA submission.
Jun 21, 2023
3 yr 1 mo ago
Today

Pharmaceutical detail

Strength

160UNITS/1.6ML (100UNITS/ML)

Dosage form

Injection

Route

Subcutaneous

Presentation

Multi-Dose Cartridge

Center

CDER

License number

1261

Product number

004

Submission type

Supplement

Supplement number

Change type

Not listed

Reference product family

View full family

This is the reference (originator) product. Its approved biosimilars and interchangeables are listed below.

3 additional BLA records for this product (other strengths or presentations) are in the same reference family.

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.

Source provenance

Source kind · Advanced Search

Checked Jul 02, 2026

FDA source FDA source

advanced-searchAdvanced Search · Jul 02, 2026
monthly-downloadMonthly download · Jul 02, 2026

Change history

v4Jul 02, 2026
v3Jul 02, 2026
v2Jul 02, 2026

Frequently asked questions

Does Fiasp have approved biosimilars?

Yes. 2 approved follow-on biologics reference Fiasp in the Purple Book: Merilog and Kirsty.

What is Fiasp's BLA number?

Fiasp is licensed under BLA 208751, held by Novo Nordisk Inc..

When was Fiasp approved by the FDA?

Fiasp was approved by the FDA on Jun 21, 2023.

Related FDA reference tools

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.

Book a Demo