Application 209885
- Type
- NDA
- Sponsor
- TEVA BRANDED PHARM
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | AUSTEDO | DEUTETRABENAZINE | TABLET;ORAL | 6MG | No | No |
| 002 | AUSTEDO | DEUTETRABENAZINE | TABLET;ORAL | 9MG | No | No |
| 003 | AUSTEDO | DEUTETRABENAZINE | TABLET;ORAL | 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 |
|---|---|---|---|---|---|---|
| Austedo | DEUTETRABENAZINE | Teva Neuroscience, Inc. | 7ea3c60a-45c7-44cc-afc2-d87fa53993c0 | 2025-02-28 | Boxed warning, Warnings, Adverse reactions | Austedo DEUTETRABENAZINE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.