Application 761046
- Type
- BLA
- Sponsor
- MERCK SHARP DOHME
Purple Book Biologic Products#
| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|---|---|---|---|---|
| 761046 | Zinplava | bezlotoxumab | 351(a) | Rx | 2026-08-01 |
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ZINPLAVA | BEZLOTOXUMAB | INJECTABLE;INJECTION | 1000ML/40ML | No | No |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| ZINPLAVA | BEZLOTOXUMAB | Merck Sharp & Dohme LLC | 8f479bfe-2bfa-4cc5-9aee-1357364480b0 | 2024-11-12 | Warnings, Adverse reactions | BLA761046 0006-3025 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0006-3025 | ZINPLAVA | bezlotoxumab | Merck Sharp & Dohme Corp. | BLA | Current |
| 0006-3025 | ZINPLAVA | bezlotoxumab | Merck Sharp & Dohme Corp. | BLA | Current |
| 0006-3025 | ZINPLAVA | bezlotoxumab | Merck Sharp & Dohme LLC | BLA | Current |
| 0006-3025 | ZINPLAVA | bezlotoxumab | Merck Sharp & Dohme Corp. | BLA | Current |