Purple Book product · Biosimilar 351(k)
Merilog
insulin aspart-szjj
Feb 14, 2025
Approved
Biosimilar 351(k)
License type
Rx
Marketing
None
Listed patents
Sourced from the FDA Purple Book · verified Jul 02, 2026
Key dates
Approval
Approval date of this BLA submission.
Feb 14, 2025
1 yr 5 mo ago
Today
Pharmaceutical detail
Strength
300UNITS/3ML (100UNITS/ML)
Dosage form
Injection
Route
Subcutaneous
Presentation
Autoinjector
Center
CDER
License number
1752
Product number
002
Submission type
Original
Supplement number
Not listed
Change type
Not listed
Reference product family
View full familyBiosimilar of insulin aspart (Novolog)
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
- 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
Is Merilog a biosimilar?
Yes. Merilog is a Biosimilar 351(k) referencing insulin aspart, licensed under a 351(k) BLA.
Is Merilog interchangeable?
Merilog is a 351(k) biosimilar but does not carry an interchangeability designation in the Purple Book, so pharmacy-level substitution depends on state law.
What is Merilog's BLA number?
Merilog is licensed under BLA 761325, held by Sanofi-Aventis U.S. LLC.
When was Merilog approved by the FDA?
Merilog was approved by the FDA on Feb 14, 2025.
Related FDA reference tools
- FDA Orange BookApproved drugs, generics, therapeutic-equivalence codes, patents, and exclusivity.
- FDA BiosimilarsThe list of FDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 & Inspection DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
