Application 218725
- Type
- ANDA
- Sponsor
- AUROBINDO PHARMA LIMITED
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 002 | SOLRIAMFETOL | SOLRIAMFETOL | TABLET | 75MG | No | No |
| 003 | SOLRIAMFETOL | SOLRIAMFETOL | TABLET | 150MG | 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 |
|---|---|---|---|---|---|---|
| SUNOSI | SOLRIAMFETOL | Axsome Therapeutics, Inc. | 362f206b-73e7-4009-8c34-5a9df55679ab | 2026-05-05 | Warnings, Adverse reactions | SOLRIAMFETOL |