Botox Cosmetic Purple Book BLA 103000
- BLA number
- 103000
- Proprietary names
- Botox Cosmetic, Botox
- Proper names
- onabotulinumtoxinA
- Applicant
- AbbVie Inc.
- Center
- CDER
- First observed release
- 2020-05-01
- Latest observed release
- 2026-06-01
- Newest archive release
- 2026-06-01
- FDA patent list
- No patents listed in the captured FDA patent list; source updated 2025-06-11
- Coverage
- Present in newest release
Latest Known Product Presentations#
Product, Proprietary name, Proper name table| Product | Proprietary name | Proper name | License type | Strength | Dosage form | Route | Presentation | Marketing | Licensure | Approval | Patent list provided |
|---|
| 001 | Botox Cosmetic | onabotulinumtoxinA | 351(a) | 50UNITS | For Injection | Intramuscular | Single-Dose Vial | Rx | Licensed | 1991-12-09 | |
| 002 | Botox Cosmetic | onabotulinumtoxinA | 351(a) | 100UNITS | For Injection | Intramuscular | Single-Dose Vial | Rx | Licensed | 1991-12-09 | |
| 003 | Botox | onabotulinumtoxinA | 351(a) | 50UNITS | For Injection | Injection, Intramuscular, Intradermal, Intradetrusor | Single-Dose Vial | Disc | Licensed | 1991-12-09 | |
| 004 | Botox | onabotulinumtoxinA | 351(a) | 100UNITS | For Injection | Injection, Intramuscular, Intradermal, Intradetrusor | Single-Dose Vial | Rx | Licensed | 1991-12-09 | |
| 005 | Botox | onabotulinumtoxinA | 351(a) | 200UNITS | For Injection | Injection, Intramuscular, Intradermal, Intradetrusor | Single-Dose Vial | Rx | Licensed | 1991-12-09 | |
Published Patent List#
No patents for this BLA were listed in the FDA Purple Book patent list captured from the source updated 2025-06-11.
Official Monthly Change Events#
Release, Event, Product table| Release | Event | Product | Name | License type | Status | Applicant |
|---|
| 2023-11-01 | U | 001 | Botox Cosmetic | 351(a) | Rx | AbbVie Inc. |
| 2023-11-01 | U | 002 | Botox Cosmetic | 351(a) | Rx | AbbVie Inc. |
| 2023-11-01 | U | 003 | Botox | 351(a) | Disc | AbbVie Inc. |
| 2023-11-01 | U | 004 | Botox | 351(a) | Rx | AbbVie Inc. |
| 2023-11-01 | U | 005 | Botox | 351(a) | Rx | AbbVie Inc. |
| 2022-08-01 | U | 003 | Botox | 351(a) | Disc | Allergan, Inc. |
| 2021-05-01 | U | 001 | Botox Cosmetic | 351(a) | Rx | Allergan, Inc. |
| 2021-05-01 | U | 002 | Botox Cosmetic | 351(a) | Rx | Allergan, Inc. |
| 2021-05-01 | U | 003 | Botox | 351(a) | Rx | Allergan, Inc. |
| 2021-05-01 | U | 004 | Botox | 351(a) | Rx | Allergan, Inc. |
| 2021-05-01 | U | 005 | Botox | 351(a) | Rx | Allergan, Inc. |
| 2020-08-01 | U | 001 | Botox Cosmetic | 351(a) | Rx | Allergan Pharmaceuticals Ireland |
| 2020-08-01 | U | 002 | Botox Cosmetic | 351(a) | Rx | Allergan Pharmaceuticals Ireland |
| 2020-08-01 | U | 003 | Botox | 351(a) | Rx | Allergan Pharmaceuticals Ireland |
| 2020-08-01 | U | 004 | Botox | 351(a) | Rx | Allergan Pharmaceuticals Ireland |
| 2020-08-01 | U | 005 | Botox | 351(a) | Rx | Allergan Pharmaceuticals Ireland |
| 2020-05-01 | R | 001 | Botox Cosmetic | 351(a) | Rx | Allergan Pharmaceuticals Ireland |
| 2020-05-01 | R | 002 | Botox Cosmetic | 351(a) | Rx | Allergan Pharmaceuticals Ireland |
| 2020-05-01 | R | 003 | Botox | 351(a) | Rx | Allergan Pharmaceuticals Ireland |
| 2020-05-01 | R | 004 | Botox | 351(a) | Rx | Allergan Pharmaceuticals Ireland |
| 2020-05-01 | R | 005 | Botox | 351(a) | Rx | Allergan Pharmaceuticals Ireland |
Observed Product State History#
Release, Product, Name table| Release | Product | Name | License type | Marketing | Licensure | Approval |
|---|
| 2022-08-01 | 003 | Botox | 351(a) | Disc | Licensed | 1991-12-09 |
| 2020-05-01 | 001 | Botox Cosmetic | 351(a) | Rx | Licensed | 1991-12-09 |
| 2020-05-01 | 002 | Botox Cosmetic | 351(a) | Rx | Licensed | 1991-12-09 |
| 2020-05-01 | 003 | Botox | 351(a) | Rx | Licensed | 1991-12-09 |
| 2020-05-01 | 004 | Botox | 351(a) | Rx | Licensed | 1991-12-09 |
| 2020-05-01 | 005 | Botox | 351(a) | Rx | Licensed | 1991-12-09 |