Purple Book product · Reference 351(a)
Botox
onabotulinumtoxinA
Dec 09, 1991
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.
Dec 09, 1991
35 yr 1 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
Jun 20, 2026
28 d ago
Today
Pharmaceutical detail
Strength
50UNITS
Dosage form
For Injection
Route
Injection, Intramuscular, Intradermal, Intradetrusor
Presentation
Single-Dose Vial
Center
CDER
License number
1889
Product number
003
Submission type
Original
Supplement number
Not listed
Change type
Not listed
Reference product family
View full familyThis is the reference (originator) product. Its approved biosimilars and interchangeables are listed below.
2 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
- 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 Botox have approved biosimilars?
Yes. 1 approved follow-on biologic reference Botox in the Purple Book: Botox Cosmetic.
What is Botox's BLA number?
Botox is licensed under BLA 103000, held by AbbVie Inc..
When was Botox approved by the FDA?
Botox was approved by the FDA on Dec 09, 1991.
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.
