| 0143-9466-06 |
0143-9466 |
HUMAN PRESCRIPTION DRUG |
TYZAVAN |
Vancomycin |
INJECTION, SOLUTION |
INTRAVENOUS |
20251017 |
N/A |
NDA |
NDA211962 |
Hikma Pharmaceuticals USA Inc. |
VANCOMYCIN |
1.25 g/250mL |
6 BAG in 1 CARTON (0143-9466-06) / 250 mL in 1 BAG (0143-9466-01) |
| 0143-9467-06 |
0143-9467 |
HUMAN PRESCRIPTION DRUG |
TYZAVAN |
Vancomycin |
INJECTION, SOLUTION |
INTRAVENOUS |
20251017 |
N/A |
NDA |
NDA211962 |
Hikma Pharmaceuticals USA Inc. |
VANCOMYCIN |
1.75 g/350mL |
6 BAG in 1 CARTON (0143-9467-06) / 350 mL in 1 BAG (0143-9467-01) |
| 0143-9468-06 |
0143-9468 |
HUMAN PRESCRIPTION DRUG |
TYZAVAN |
Vancomycin |
INJECTION, SOLUTION |
INTRAVENOUS |
20251017 |
N/A |
NDA |
NDA211962 |
Hikma Pharmaceuticals USA Inc. |
VANCOMYCIN |
750 mg/150mL |
6 BAG in 1 CARTON (0143-9468-06) / 150 mL in 1 BAG (0143-9468-01) |
| 0143-9468-12 |
0143-9468 |
HUMAN PRESCRIPTION DRUG |
TYZAVAN |
Vancomycin |
INJECTION, SOLUTION |
INTRAVENOUS |
20251017 |
N/A |
NDA |
NDA211962 |
Hikma Pharmaceuticals USA Inc. |
VANCOMYCIN |
750 mg/150mL |
12 BAG in 1 CARTON (0143-9468-12) / 150 mL in 1 BAG (0143-9468-01) |
| 0143-9469-06 |
0143-9469 |
HUMAN PRESCRIPTION DRUG |
TYZAVAN |
Vancomycin |
INJECTION, SOLUTION |
INTRAVENOUS |
20251017 |
N/A |
NDA |
NDA211962 |
Hikma Pharmaceuticals USA Inc. |
VANCOMYCIN |
1.5 g/300mL |
6 BAG in 1 CARTON (0143-9469-06) / 300 mL in 1 BAG (0143-9469-01) |
| 0143-9470-06 |
0143-9470 |
HUMAN PRESCRIPTION DRUG |
TYZAVAN |
Vancomycin |
INJECTION, SOLUTION |
INTRAVENOUS |
20251017 |
N/A |
NDA |
NDA211962 |
Hikma Pharmaceuticals USA Inc. |
VANCOMYCIN |
2 g/400mL |
6 BAG in 1 CARTON (0143-9470-06) / 400 mL in 1 BAG (0143-9470-01) |
| 0143-9471-06 |
0143-9471 |
HUMAN PRESCRIPTION DRUG |
TYZAVAN |
Vancomycin |
INJECTION, SOLUTION |
INTRAVENOUS |
20251017 |
N/A |
NDA |
NDA211962 |
Hikma Pharmaceuticals USA Inc. |
VANCOMYCIN |
500 mg/100mL |
6 BAG in 1 CARTON (0143-9471-06) / 100 mL in 1 BAG (0143-9471-01) |
| 0143-9471-12 |
0143-9471 |
HUMAN PRESCRIPTION DRUG |
TYZAVAN |
Vancomycin |
INJECTION, SOLUTION |
INTRAVENOUS |
20251017 |
N/A |
NDA |
NDA211962 |
Hikma Pharmaceuticals USA Inc. |
VANCOMYCIN |
500 mg/100mL |
12 BAG in 1 CARTON (0143-9471-12) / 100 mL in 1 BAG (0143-9471-01) |
| 0143-9472-06 |
0143-9472 |
HUMAN PRESCRIPTION DRUG |
TYZAVAN |
Vancomycin |
INJECTION, SOLUTION |
INTRAVENOUS |
20251017 |
N/A |
NDA |
NDA211962 |
Hikma Pharmaceuticals USA Inc. |
VANCOMYCIN |
1 g/200mL |
6 BAG in 1 CARTON (0143-9472-06) / 200 mL in 1 BAG (0143-9472-01) |
| 0143-9472-12 |
0143-9472 |
HUMAN PRESCRIPTION DRUG |
TYZAVAN |
Vancomycin |
INJECTION, SOLUTION |
INTRAVENOUS |
20251017 |
N/A |
NDA |
NDA211962 |
Hikma Pharmaceuticals USA Inc. |
VANCOMYCIN |
1 g/200mL |
12 BAG in 1 CARTON (0143-9472-12) / 200 mL in 1 BAG (0143-9472-01) |
| 70594-041-02 |
70594-041 |
HUMAN PRESCRIPTION DRUG |
Vancomycin |
Vancomycin |
INJECTION, SOLUTION |
INTRAVENOUS |
20190215 |
N/A |
NDA |
NDA211962 |
Xellia Pharmaceuticals USA LLC |
VANCOMYCIN |
500 mg/100mL |
6 BAG in 1 CARTON (70594-041-02) / 100 mL in 1 BAG (70594-041-01) |
| 70594-041-03 |
70594-041 |
HUMAN PRESCRIPTION DRUG |
Vancomycin |
Vancomycin |
INJECTION, SOLUTION |
INTRAVENOUS |
20190215 |
N/A |
NDA |
NDA211962 |
Xellia Pharmaceuticals USA LLC |
VANCOMYCIN |
500 mg/100mL |
12 BAG in 1 CARTON (70594-041-03) / 100 mL in 1 BAG (70594-041-01) |
| 70594-042-02 |
70594-042 |
HUMAN PRESCRIPTION DRUG |
Vancomycin |
Vancomycin |
INJECTION, SOLUTION |
INTRAVENOUS |
20190215 |
N/A |
NDA |
NDA211962 |
Xellia Pharmaceuticals USA LLC |
VANCOMYCIN |
1 g/200mL |
6 BAG in 1 CARTON (70594-042-02) / 200 mL in 1 BAG (70594-042-01) |
| 70594-042-03 |
70594-042 |
HUMAN PRESCRIPTION DRUG |
Vancomycin |
Vancomycin |
INJECTION, SOLUTION |
INTRAVENOUS |
20190215 |
N/A |
NDA |
NDA211962 |
Xellia Pharmaceuticals USA LLC |
VANCOMYCIN |
1 g/200mL |
12 BAG in 1 CARTON (70594-042-03) / 200 mL in 1 BAG (70594-042-01) |
| 70594-043-02 |
70594-043 |
HUMAN PRESCRIPTION DRUG |
Vancomycin |
Vancomycin |
INJECTION, SOLUTION |
INTRAVENOUS |
20190215 |
N/A |
NDA |
NDA211962 |
Xellia Pharmaceuticals USA LLC |
VANCOMYCIN |
1.5 g/300mL |
6 BAG in 1 CARTON (70594-043-02) / 300 mL in 1 BAG (70594-043-01) |
| 70594-044-02 |
70594-044 |
HUMAN PRESCRIPTION DRUG |
Vancomycin |
Vancomycin |
INJECTION, SOLUTION |
INTRAVENOUS |
20190215 |
N/A |
NDA |
NDA211962 |
Xellia Pharmaceuticals USA LLC |
VANCOMYCIN |
2 g/400mL |
6 BAG in 1 CARTON (70594-044-02) / 400 mL in 1 BAG (70594-044-01) |
| 70594-056-02 |
70594-056 |
HUMAN PRESCRIPTION DRUG |
Vancomycin |
Vancomycin |
INJECTION, SOLUTION |
INTRAVENOUS |
20200513 |
N/A |
NDA |
NDA211962 |
Xellia Pharmaceuticals USA LLC |
VANCOMYCIN |
750 mg/150mL |
6 BAG in 1 CARTON (70594-056-02) / 150 mL in 1 BAG (70594-056-01) |
| 70594-056-03 |
70594-056 |
HUMAN PRESCRIPTION DRUG |
Vancomycin |
Vancomycin |
INJECTION, SOLUTION |
INTRAVENOUS |
20200513 |
N/A |
NDA |
NDA211962 |
Xellia Pharmaceuticals USA LLC |
VANCOMYCIN |
750 mg/150mL |
12 BAG in 1 CARTON (70594-056-03) / 150 mL in 1 BAG (70594-056-01) |
| 70594-057-02 |
70594-057 |
HUMAN PRESCRIPTION DRUG |
Vancomycin |
Vancomycin |
INJECTION, SOLUTION |
INTRAVENOUS |
20200513 |
N/A |
NDA |
NDA211962 |
Xellia Pharmaceuticals USA LLC |
VANCOMYCIN |
1.25 g/250mL |
6 BAG in 1 CARTON (70594-057-02) / 250 mL in 1 BAG (70594-057-01) |
| 70594-058-02 |
70594-058 |
HUMAN PRESCRIPTION DRUG |
Vancomycin |
Vancomycin |
INJECTION, SOLUTION |
INTRAVENOUS |
20200513 |
N/A |
NDA |
NDA211962 |
Xellia Pharmaceuticals USA LLC |
VANCOMYCIN |
1.75 g/350mL |
6 BAG in 1 CARTON (70594-058-02) / 350 mL in 1 BAG (70594-058-01) |