FdaApplication
ANDA 218314
Identifiers
- fda_app_no: ANDA218314
Properties
| Property | Value |
|---|---|
| applicant_name | AMERICAN REGENT INC |
| application_type | ANDA |
| approval_date | 2024-06-21 |
Products (3)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| SODIUM PHOSPHATES | SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE | 13.4GM/50ML;13.8GM/50ML (268MG/ML | SOLUTION;INTRAVENOUS |
| SODIUM PHOSPHATES | SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE | 4.02GM/15ML;4.14GM/15ML (268MG/ML | SOLUTION;INTRAVENOUS |
| SODIUM PHOSPHATES | SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE | 1.34GM/5ML;1.38GM/5ML (268MG/ML | SOLUTION;INTRAVENOUS |
3 products