Purple Book product · Reference 351(a)
Botox
onabotulinumtoxinA
At a glance
Dec 09, 1991
Approved
Reference 351(a)
License type
Disc
Marketing
No
Patents listed
Key dates
Approval
Approval date of this BLA submission.
Dec 09, 1991
35 yr ago
Today
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
Jun 20, 2026
in 16 d
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. Biosimilars and interchangeables referencing it are listed below.
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.
Taxonomy and ontology
11 termscenter
Center for Drug Evaluation and Research
center · CDER
application pathway
Biologics License Application
blaNumber · BLA
license type
351(a)
blaType · 351(a)
application pathway
Section 351(a) Biologic
blaType · 351(a)
product role
Reference or Standalone Biologic
blaType · Reference product
marketing status
Discontinued
marketingStatus · Disc
licensure status
Licensed
licensure · Licensed
dosage form
For Injection
dosageForm · For Injection
source kind
Monthly Download
sourceKind · monthly_download
patent status
No Patent List Provided
patentListProvided · No patent list
- Food and Drug Administrationparent ofCenter for Drug Evaluation and Research
- Food and Drug Administrationsource forMonthly Download
- Biologics License Applicationparent ofSection 351(a) Biologic
- Biologics License Applicationparent ofSection 351(k) Biosimilar or Interchangeable
- Section 351(a) Biologicmaps to351(a)
- 351(a)classifiesReference or Standalone Biologic
Source provenance
