FdaApplication
ANDA 219287
Identifiers
- fda_app_no: ANDA219287
Properties
| Property | Value |
|---|---|
| applicant_name | VIWIT PHARMACEUTICAL CO LTD |
| application_type | ANDA |
| approval_date | 2026-06-11 |
Products (3)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| GADOBUTROL | GADOBUTROL | 4.5354GM/7.5ML (604.72MG/ML) | SOLUTION;INTRAVENOUS |
| GADOBUTROL | GADOBUTROL | 9.0708GM/15ML (604.72MG/ML) | SOLUTION;INTRAVENOUS |
| GADOBUTROL | GADOBUTROL | 6.0472GM/10ML (604.72MG/ML) | SOLUTION;INTRAVENOUS |
3 products