Gardasil Purple Book BLA 125126
- BLA number
- 125126
- Proprietary names
- Gardasil
- Proper names
- Human Papillomavirus Quadrivalent (Types 6, 11, 16 and 18) Vaccine, Recombinant
- Applicant
- Merck Sharp & Dohme LLC
- 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 | Gardasil | Human Papillomavirus Quadrivalent (Types 6, 11, 16 and 18) Vaccine, Recombinant | 351(a) | 120MCG L1 PROTEIN FROM HPV 6, 11, 16 AND 18 UG/.5ML | Injection | Intramuscular | Syringe | Disc | Licensed | 2006-06-08 | |
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 |
|---|
| 2023-03-01 | U | 001 | Gardasil | 351(a) | Disc | Merck Sharp & Dohme LLC |
| 2021-05-01 | U | 001 | Gardasil | 351(a) | Disc | Merck Sharp & Dohme Corp. |
| 2020-08-01 | R | 001 | Gardasil | 351(a) | Disc | Merck Sharp & Dohme Corp. |
Observed Product State History#
Release, Product, Name table| Release | Product | Name | License type | Marketing | Licensure | Approval |
|---|
| 2020-08-01 | 001 | Gardasil | 351(a) | Disc | Licensed | 2006-06-08 |