Application 761046
- Type
- BLA
- Sponsor
- MERCK SHARP DOHME
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ZINPLAVA | BEZLOTOXUMAB | INJECTABLE;INJECTION | 1000ML/40ML | No | No |
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 |