FdaApplication
ANDA 219286
Identifiers
- fda_app_no: ANDA219286
Properties
| Property | Value |
|---|---|
| applicant_name | VIWIT PHARMACEUTICAL CO LTD |
| application_type | ANDA |
| approval_date | 2026-08-10 |
Products (3)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| GADOTERATE MEGLUMINE | GADOTERATE MEGLUMINE | 7.538GM/20ML (376.9MG/ML) | SOLUTION;INTRAVENOUS |
| GADOTERATE MEGLUMINE | GADOTERATE MEGLUMINE | 3.769GM/10ML (376.9MG/ML) | SOLUTION;INTRAVENOUS |
| GADOTERATE MEGLUMINE | GADOTERATE MEGLUMINE | 5.6535GM/15ML (376.9MG/ML) | SOLUTION;INTRAVENOUS |
3 products