Application 761363
- Type
- BLA
- Sponsor
- MERCK SHARP DOHME
Purple Book Biologic Products#
| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|---|---|---|---|---|
| 761363 | Winrevair | sotatercept-csrk | 351(a) | Rx | 2026-08-01 |
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | WINREVAIR | SOTATERCEPT-CSRK | INJECTABLE;INJECTION | 45MG | No | No |
| 002 | WINREVAIR | SOTATERCEPT-CSRK | INJECTABLE;INJECTION | 60MG | 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 |
|---|---|---|---|---|---|---|
| WINREVAIR | SOTATERCEPT-CSRK | Merck Sharp & Dohme LLC | 21693ee2-cd23-4137-ac67-066bb3a4a9b7 | 2026-08-12 | Warnings, Adverse reactions | BLA761363 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.