Zinplava Purple Book BLA 761046
- BLA number
- 761046
- Proprietary names
- Zinplava
- Proper names
- bezlotoxumab
- Applicant
- Merck Sharp & Dohme LLC
- 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 | Zinplava | bezlotoxumab | 351(a) | 1,000MG/40ML (25MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | 2016-10-21 | |
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 | Zinplava | 351(a) | Rx | Merck Sharp & Dohme LLC |
| 2020-05-01 | R | 001 | Zinplava | 351(a) | Rx | Merck Sharp & Dohme Corp. |
Observed Product State History#
Release, Product, Name table| Release | Product | Name | License type | Marketing | Licensure | Approval |
|---|
| 2020-05-01 | 001 | Zinplava | 351(a) | Rx | Licensed | 2016-10-21 |