Application 021708
- Type
- NDA
- Sponsor
- SOMERSET
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | EMSAM | SELEGILINE | SYSTEM; TRANSDERMAL | 6MG | No | No |
| 002 | EMSAM | SELEGILINE | SYSTEM; TRANSDERMAL | 9MG | No | No |
| 003 | EMSAM | SELEGILINE | SYSTEM; TRANSDERMAL | 12MG | 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 |
|---|---|---|---|---|---|---|
| EMSAM | SELEGILINE | Viatris Specialty LLC | b891bd9f-fdb8-4862-89c5-ecdd700398a3 | 2020-05-15 | Boxed warning, Warnings, Adverse reactions | EMSAM SELEGILINE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.