Vaxchora Purple Book BLA 125597
- BLA number
- 125597
- Proprietary names
- Vaxchora
- Proper names
- Cholera Vaccine, Live, Oral
- Applicant
- Bavarian Nordic A/S
- Center
- CBER
- First observed release
- 2020-08-01
- 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 | Vaxchora | Cholera Vaccine, Live, Oral | 351(a) | 100ML | Suspension | Oral | Packet | Rx | Licensed | 2016-06-10 | |
| 002 | Vaxchora | Cholera Vaccine, Live, Oral | 351(a) | 50ML | Suspension | Oral | Packet | Rx | Licensed | 2020-12-23 | |
| 003 | Vaxchora | Cholera Vaccine, Live, Oral | 351(a) | 100ML | Suspension | Oral | Packet | Rx | Licensed | 2020-12-23 | |
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 |
|---|
| 2025-07-01 | U | 001 | Vaxchora | 351(a) | Rx | Bavarian Nordic A/S |
| 2025-07-01 | U | 002 | Vaxchora | 351(a) | Rx | Bavarian Nordic A/S |
| 2025-07-01 | U | 003 | Vaxchora | 351(a) | Rx | Bavarian Nordic A/S |
| 2024-03-01 | U | 001 | Vaxchora | 351(a) | Rx | Bavarian Nordic A/S |
| 2024-03-01 | U | 002 | Vaxchora | 351(a) | Rx | Bavarian Nordic A/S |
| 2024-03-01 | U | 003 | Vaxchora | 351(a) | Rx | Bavarian Nordic A/S |
| 2021-07-01 | U | 002 | Vaxchora | 351(a) | Rx | Emergent Travel Health, Inc. |
| 2021-07-01 | U | 003 | Vaxchora | 351(a) | Rx | Emergent Travel Health, Inc. |
| 2021-05-01 | U | 001 | Vaxchora | 351(a) | Rx | Emergent Travel Health, Inc. |
| 2021-05-01 | U | 002 | Vaxchora | 351(a) | Rx | Emergent Travel Health, Inc. |
| 2021-05-01 | U | 003 | Vaxchora | 351(a) | Rx | Emergent Travel Health, Inc. |
| 2021-01-01 | U | 001 | Vaxchora | 351(a) | Rx | Emergent Travel Health, Inc. |
| 2021-01-01 | N | 002 | Vaxchora | 351(a) | Rx | Emergent Travel Health, Inc. |
| 2021-01-01 | N | 003 | Vaxchora | 351(a) | Rx | Emergent Travel Health, Inc. |
| 2020-08-01 | R | 001 | Vaxchora | 351(a) | Rx | PaxVax Bermuda Ltd. |
Observed Product State History#
Release, Product, Name table| Release | Product | Name | License type | Marketing | Licensure | Approval |
|---|
| 2025-07-01 | 001 | Vaxchora | 351(a) | Rx | Licensed | 2016-06-10 |
| 2025-07-01 | 002 | Vaxchora | 351(a) | Rx | Licensed | 2020-12-23 |
| 2025-07-01 | 003 | Vaxchora | 351(a) | Rx | Licensed | 2020-12-23 |
| 2021-01-01 | 002 | Vaxchora | 351(a) | Rx | Licensed | 2020-12-23 |
| 2021-01-01 | 003 | Vaxchora | 351(a) | Rx | Licensed | 2020-12-23 |
| 2020-08-01 | 001 | Vaxchora | 351(a) | Rx | Licensed | 2016-06-10 |