FDA approved the original biologics license application for BOTOX COSMETIC on December 9, 1991, sponsored by ALLERGAN. FDA classed that submission a new molecular entity, which makes it the first approval of onabotulinumtoxina in any product. FDA has approved 24 efficacy supplements on the application since, the most recent on October 18, 2024.
- Application
- BLA103000
- Sponsor
- ALLERGAN
- Original approval
- Submission class
- Type 1 - New Molecular Entity
- Active ingredient
- onabotulinumtoxina
Browse every approval whose brand starts with B, or the complete response letters FDA has published — the applications it did not approve.
Products under this application
| Ingredient and strength | Form | Route | Marketing status |
|---|---|---|---|
| onabotulinumtoxina 100 UNITS/VIAL | VIAL | SINGLE-USE | Prescription |
| onabotulinumtoxina 200 UNITS/VIAL | VIAL | SINGLE-USE | Prescription |
| onabotulinumtoxina 50 UNITS/VIAL | VIAL | SINGLE-USE | Prescription |
| onabotulinumtoxina 50 UNITS/VIAL | VIAL | SINGLE-USE | Prescription |
| onabotulinumtoxina 100 UNITS/VIAL | VIAL | SINGLE-USE | Prescription |
Approved efficacy supplements
An efficacy supplement is how a sponsor asks FDA to approve a change that needs clinical evidence — most often a new indication. FDA’s record gives each one a submission number, a date and a review priority. It does not say what any supplement approved, so neither does this page. The approval letter and label for each are on accessdata.fda.gov under the application number.
| Approved | Supplement | Review |
|---|---|---|
| S-1004 | — | |
| S-5000 | standard | |
| S-5050 | standard | |
| S-5189 | priority | |
| S-5129 | standard | |
| S-5215 | standard | |
| S-5232 | standard | |
| S-5251 | standard | |
| S-5260 | standard | |
| S-5282 | standard | |
| S-5252 | standard | |
| S-5294 | standard | |
| S-5298 | standard | |
| S-5296 | standard | |
| S-5297 | standard | |
| S-5303 | standard | |
| S-5308 | standard | |
| S-5309 | priority | |
| S-5310 | standard | |
| S-5315 | standard | |
| S-5318 | standard | |
| S-5320 | standard | |
| S-5325 | standard | |
| S-5331 | standard |
FDA records other approved supplements on this application, by the class code it assigns them: Labeling 20 · Supplement 15. Those are changes to the label or to how the drug is made rather than new clinical evidence, so they are counted here and not listed.
Source: FDA’s Drugs@FDA application file, via openFDA (export 2026-09-03). Every field on this page comes from that record.
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