FdaApplication
ANDA 218381
Identifiers
- fda_app_no: ANDA218381
Properties
| Property | Value |
|---|---|
| applicant_name | APOTEX INC |
| application_type | ANDA |
| approval_date | 2025-11-10 |
Products (5)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| TOLVAPTAN | TOLVAPTAN | 15MG | TABLET;ORAL |
| TOLVAPTAN | TOLVAPTAN | 90MG | TABLET;ORAL |
| TOLVAPTAN | TOLVAPTAN | 60MG | TABLET;ORAL |
| TOLVAPTAN | TOLVAPTAN | 30MG | TABLET;ORAL |
| TOLVAPTAN | TOLVAPTAN | 45MG | TABLET;ORAL |
5 products