FdaApplication
NDA 216354
Identifiers
- fda_app_no: NDA216354
Properties
| Property | Value |
|---|---|
| applicant_name | TEVA NEUROSCIENCE INC |
| application_type | NDA |
| approval_date | 2023-02-17 |
Products (8)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| AUSTEDO XR | DEUTETRABENAZINE | 6MG | TABLET, EXTENDED RELEASE;ORAL |
| AUSTEDO XR | DEUTETRABENAZINE | 42MG | TABLET, EXTENDED RELEASE;ORAL |
| AUSTEDO XR | DEUTETRABENAZINE | 24MG | TABLET, EXTENDED RELEASE;ORAL |
| AUSTEDO XR | DEUTETRABENAZINE | 12MG | TABLET, EXTENDED RELEASE;ORAL |
| AUSTEDO XR | DEUTETRABENAZINE | 18MG | TABLET, EXTENDED RELEASE;ORAL |
| AUSTEDO XR | DEUTETRABENAZINE | 36MG | TABLET, EXTENDED RELEASE;ORAL |
| AUSTEDO XR | DEUTETRABENAZINE | 30MG | TABLET, EXTENDED RELEASE;ORAL |
| AUSTEDO XR | DEUTETRABENAZINE | 48MG | TABLET, EXTENDED RELEASE;ORAL |
8 products