FdaApplication
ANDA 219146
Identifiers
- fda_app_no: ANDA219146
Properties
| Property | Value |
|---|---|
| applicant_name | ZENARA PHARMA PRIVATE LTD |
| application_type | ANDA |
| approval_date | 2026-06-08 |
Products (6)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| GADOBUTROL | GADOBUTROL | 1.20944GM/2ML (604.72MG/ML) | SOLUTION;INTRAVENOUS |
| GADOBUTROL | GADOBUTROL | 18.1416GM/30ML (604.72MG/ML) | SOLUTION;INTRAVENOUS |
| 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 |
| GADOBUTROL | GADOBUTROL | 39.3068GM/65ML (604.72MG/ML) | SOLUTION;INTRAVENOUS |
6 products