Purple Book product · Reference 351(a)
Nutropin
somatropin
Nov 17, 1993
Approved
Reference 351(a)
License type
Disc
Marketing
None
Listed patents
Sourced from the FDA Purple Book · verified Jul 02, 2026
Key dates
Approval
Approval date of this BLA submission.
Nov 17, 1993
33 yr 1 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
Dec 30, 2003
22 yr 10 mo ago
Today
Pharmaceutical detail
Strength
5MG
Dosage form
For Injection
Route
Subcutaneous
Presentation
Multi-Dose Vial
Center
CDER
License number
1048
Product number
001
Submission type
Original
Supplement number
Not listed
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.
1 additional BLA record 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 Nutropin have approved biosimilars?
No 351(k) biosimilars or interchangeable biosimilars referencing Nutropin are listed in the FDA Purple Book yet.
What is Nutropin's BLA number?
Nutropin is licensed under BLA 20168, held by Genentech, Inc..
When was Nutropin approved by the FDA?
Nutropin was approved by the FDA on Nov 17, 1993.
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.
