FdaApplication
ANDA 216344
Identifiers
- fda_app_no: ANDA216344
Properties
| Property | Value |
|---|---|
| applicant_name | AMNEAL EU LTD |
| application_type | ANDA |
| approval_date | 2023-10-10 |
Products (3)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| POTASSIUM PHOSPHATES | POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC | 11.8GM/50ML (236MG/ML);11.2GM/50ML (224MG/ML) | SOLUTION;INTRAVENOUS |
| POTASSIUM PHOSPHATES | POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC | 1.18GM/5ML (236MG/ML);1.12GM/5ML (224MG/ML) | SOLUTION;INTRAVENOUS |
| POTASSIUM PHOSPHATES | POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC | 3.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/ML) | SOLUTION;INTRAVENOUS |
3 products