Purple Book product · Reference 351(a)
Humatrope
somatropin
Feb 04, 1999
Approved
Reference 351(a)
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 04, 1999
27 yr 10 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
Nov 01, 2013
12 yr 10 mo ago
Today
Pharmaceutical detail
Strength
12MG
Dosage form
For Injection
Route
Subcutaneous
Presentation
Multi-Dose Cartridge
Center
CDER
License number
1891
Product number
006
Submission type
Supplement
Supplement number
22
Change type
Not listed
Reference product family
View full familyThis is the reference (originator) product. No biosimilars or interchangeables reference it in the Purple Book yet.
4 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
- monthly-downloadMonthly download · Jul 02, 2026
Change history
- v2Jul 02, 2026
- v1Jul 02, 2026
Frequently asked questions
Does Humatrope have approved biosimilars?
No 351(k) biosimilars or interchangeable biosimilars referencing Humatrope are listed in the FDA Purple Book yet.
What is Humatrope's BLA number?
Humatrope is licensed under BLA 19640, held by Eli Lilly and Company.
When was Humatrope approved by the FDA?
Humatrope was approved by the FDA on Feb 04, 1999.
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.
