Drug application
MERCK SHARP AND DOHME LLC
Drugs@FDA BLA 761495 · MERCK SHARP AND DOHME LLC
Key facts
| Application type | BLA |
|---|---|
| Application number | 761495 |
| Company | MERCK SHARP AND DOHME LLC |
| Reference listed drug | No |
| Latest submission class | Type 9 - New indication submitted as distinct BLA, consolidated |
| Latest submission status date | Oct 15, 2025 |
At a glance
- 1–9 Submissions
- None Label versions
- None Products
- None Therapeutic equivalents
- Yes FDA letters on file
- No FDA reviews on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About Drugs@FDA applications
Drugs@FDA covers FDA-approved brand-name and generic drugs and therapeutic biologics, with their applications (NDA, ANDA or BLA), products, submissions and labels.
Source: U.S. Food and Drug Administration (FDA), Drugs@FDA · Source date: