Rotarix Purple Book BLA 125265
- BLA number
- 125265
- Proprietary names
- Rotarix
- Proper names
- Rotavirus Vaccine, Live, Oral
- Applicant
- GlaxoSmithKline Biologicals
- 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 | Rotarix | Rotavirus Vaccine, Live, Oral | 351(a) | 1ML | For Suspension | Oral | Single-Dose Vial | Disc | Licensed | 2008-04-03 | |
| 002 | Rotarix | Rotavirus Vaccine, Live, Oral | 351(a) | 106.0CCID50 | Suspension | Oral | Tube | Disc | Licensed | 2022-11-04 | |
| 003 | Rotarix | Rotavirus Vaccine, Live, Oral | 351(a) | 106.0CCID50 | Suspension | Oral | Oral Applicator | Rx | Licensed | 2022-11-04 | |
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 |
|---|
| 2024-12-01 | U | 002 | Rotarix | 351(a) | Disc | GlaxoSmithKline Biologicals |
| 2024-04-01 | U | 001 | Rotarix | 351(a) | Disc | GlaxoSmithKline Biologicals |
| 2022-11-01 | N | 002 | Rotarix | 351(a) | Rx | GlaxoSmithKline Biologicals |
| 2022-11-01 | N | 003 | Rotarix | 351(a) | Rx | GlaxoSmithKline Biologicals |
| 2021-05-01 | U | 001 | Rotarix | 351(a) | Rx | GlaxoSmithKline Biologicals |
| 2020-08-01 | R, U | 001 | Rotarix | 351(a) | Rx | GlaxoSmithKline Biologicals |
Observed Product State History#
Release, Product, Name table| Release | Product | Name | License type | Marketing | Licensure | Approval |
|---|
| 2024-12-01 | 002 | Rotarix | 351(a) | Disc | Licensed | 2022-11-04 |
| 2024-04-01 | 001 | Rotarix | 351(a) | Disc | Licensed | 2008-04-03 |
| 2022-11-01 | 002 | Rotarix | 351(a) | Rx | Licensed | 2022-11-04 |
| 2022-11-01 | 003 | Rotarix | 351(a) | Rx | Licensed | 2022-11-04 |
| 2020-08-01 | 001 | Rotarix | 351(a) | Rx | Licensed | 2008-04-03 |