| 81665-204-01 |
81665-204 |
HUMAN PRESCRIPTION DRUG |
SODIUM PHENYLACETATE and SODIUM BENZOATE |
sodium phenylacetate and sodium benzoate |
INJECTION, SOLUTION, CONCENTRATE |
INTRAVENOUS |
20250515 |
N/A |
ANDA |
ANDA207096 |
Omnivium Pharmaceuticals LLC |
SODIUM BENZOATE; SODIUM PHENYLACETATE |
100 mg/mL; 100 mg/mL |
1 VIAL, SINGLE-DOSE in 1 CARTON (81665-204-01) / 50 mL in 1 VIAL, SINGLE-DOSE |
| 81665-203-01 |
81665-203 |
HUMAN PRESCRIPTION DRUG |
SODIUM PHENYLACETATE and SODIUM BENZOATE |
sodium phenylacetate and sodium benzoate |
INJECTION, SOLUTION, CONCENTRATE |
INTRAVENOUS |
20250225 |
N/A |
ANDA |
ANDA207096 |
Omnivium Pharmaceuticals LLC |
SODIUM BENZOATE; SODIUM PHENYLACETATE |
100 mg/mL; 100 mg/mL |
1 VIAL, SINGLE-DOSE in 1 CARTON (81665-203-01) / 50 mL in 1 VIAL, SINGLE-DOSE |
| 70556-100-50 |
70556-100 |
HUMAN PRESCRIPTION DRUG |
SODIUM PHENYLACETATE and SODIUM BENZOATE |
sodium phenylacetate and sodium benzoate |
INJECTION, SOLUTION, CONCENTRATE |
INTRAVENOUS |
20160226 |
N/A |
ANDA |
ANDA207096 |
Ailex Pharmaceuticals, LLC |
SODIUM BENZOATE; SODIUM PHENYLACETATE |
100 mg/mL; 100 mg/mL |
1 VIAL, SINGLE-DOSE in 1 CARTON (70556-100-50) / 50 mL in 1 VIAL, SINGLE-DOSE |