Purple Book product · Interchangeable
Langlara
insulin glargine-aldy
Apr 29, 2026
Approved
Interchangeable
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.
Apr 29, 2026
2 mo ago
Today
Pharmaceutical detail
Strength
300UNITS/3ML (100UNITS/ML)
Dosage form
Injection
Route
Subcutaneous
Presentation
Autoinjector
Center
CDER
License number
2343
Product number
001
Submission type
Original
Supplement number
Not listed
Change type
Not listed
Reference product family
View full familyBiosimilar of insulin glargine (Lantus)
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
- v3Jul 02, 2026
- v2Jul 02, 2026
- v1Jul 02, 2026
Frequently asked questions
Is Langlara a biosimilar?
Yes. Langlara is a Interchangeable referencing insulin glargine, licensed under a 351(k) BLA.
Is Langlara interchangeable?
Yes. Langlara carries an FDA interchangeability designation, so it may be substituted for the reference product at the pharmacy without prescriber involvement, subject to state law.
What is Langlara's BLA number?
Langlara is licensed under BLA 761412, held by Sunshine Lake Pharma Co., Ltd..
When was Langlara approved by the FDA?
Langlara was approved by the FDA on Apr 29, 2026.
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.
