FdaApplication
NDA 219627
Identifiers
- fda_app_no: NDA219627
Properties
| Property | Value |
|---|---|
| applicant_name | BAYER HEALTHCARE PHARMACEUTICALS INC |
| application_type | NDA |
| approval_date | 2026-06-12 |
Products (6)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| AMBELVIST | GADOQUATRANE | 2.579GM/10ML (257.9MG/ML) | SOLUTION;INTRAVENOUS |
| AMBELVIST | GADOQUATRANE | 1.93425GM/7.5ML (257.9MG/ML) | SOLUTION;INTRAVENOUS |
| AMBELVIST | GADOQUATRANE | 7.737GM/30ML (257.9MG/ML) | SOLUTION;INTRAVENOUS |
| AMBELVIST | GADOQUATRANE | 16.7635GM/65ML (257.9MG/ML) | SOLUTION;INTRAVENOUS |
| AMBELVIST | GADOQUATRANE | 0.5158GM/2ML (257.9MG/ML) | SOLUTION;INTRAVENOUS |
| AMBELVIST | GADOQUATRANE | 3.8685GM/15ML (257.9MG/ML) | SOLUTION;INTRAVENOUS |
6 products