| 71467-014-01 |
71467-014 |
HUMAN PRESCRIPTION DRUG |
VANCOMYCIN HYDROCHLORIDE |
vancomycin hydrochloride |
INJECTION, POWDER, FOR SOLUTION |
INTRAVENOUS; ORAL |
20240823 |
N/A |
NDA |
NDA210274 |
Zhejiang Novus Pharma Co., Ltd. |
VANCOMYCIN HYDROCHLORIDE |
10.25 g/g |
1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (71467-014-01) / 10.25 g in 1 VIAL, PHARMACY BULK PACKAGE |
| 0143-9161-10 |
0143-9161 |
HUMAN PRESCRIPTION DRUG |
VANCOMYCIN HYDROCHLORIDE |
vancomycin hydrochloride |
INJECTION, POWDER, FOR SOLUTION |
INTRAVENOUS; ORAL |
20241203 |
N/A |
NDA |
NDA210274 |
HIKMA PHARMACEUTICALS USA INC. |
VANCOMYCIN HYDROCHLORIDE |
513 mg/mg |
10 VIAL in 1 PACKAGE (0143-9161-10) / 513 mg in 1 VIAL (0143-9161-01) |
| 0143-9161-25 |
0143-9161 |
HUMAN PRESCRIPTION DRUG |
VANCOMYCIN HYDROCHLORIDE |
vancomycin hydrochloride |
INJECTION, POWDER, FOR SOLUTION |
INTRAVENOUS; ORAL |
20230202 |
N/A |
NDA |
NDA210274 |
HIKMA PHARMACEUTICALS USA INC. |
VANCOMYCIN HYDROCHLORIDE |
513 mg/mg |
25 VIAL in 1 PACKAGE (0143-9161-25) / 513 mg in 1 VIAL (0143-9161-01) |
| 0143-9162-10 |
0143-9162 |
HUMAN PRESCRIPTION DRUG |
VANCOMYCIN HYDROCHLORIDE |
vancomycin hydrochloride |
INJECTION, POWDER, FOR SOLUTION |
INTRAVENOUS; ORAL |
20230202 |
N/A |
NDA |
NDA210274 |
HIKMA PHARMACEUTICALS USA INC. |
VANCOMYCIN HYDROCHLORIDE |
1025 mg/mg |
10 VIAL in 1 PACKAGE (0143-9162-10) / 1025 mg in 1 VIAL (0143-9162-01) |
| 0143-9163-01 |
0143-9163 |
HUMAN PRESCRIPTION DRUG |
VANCOMYCIN HYDROCHLORIDE |
vancomycin hydrochloride |
INJECTION, POWDER, FOR SOLUTION |
INTRAVENOUS; ORAL |
20230203 |
N/A |
NDA |
NDA210274 |
HIKMA PHARMACEUTICALS USA INC. |
VANCOMYCIN HYDROCHLORIDE |
5.13 g/g |
1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (0143-9163-01) / 5.13 g in 1 VIAL, PHARMACY BULK PACKAGE |
| 0143-9164-01 |
0143-9164 |
HUMAN PRESCRIPTION DRUG |
VANCOMYCIN HYDROCHLORIDE |
vancomycin hydrochloride |
INJECTION, POWDER, FOR SOLUTION |
INTRAVENOUS; ORAL |
20230203 |
N/A |
NDA |
NDA210274 |
HIKMA PHARMACEUTICALS USA INC. |
VANCOMYCIN HYDROCHLORIDE |
10.25 g/g |
1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (0143-9164-01) / 10.25 g in 1 VIAL, PHARMACY BULK PACKAGE |
| 0143-9473-10 |
0143-9473 |
HUMAN PRESCRIPTION DRUG |
VANCOMYCIN HYDROCHLORIDE |
vancomycin hydrochloride |
INJECTION, POWDER, FOR SOLUTION |
INTRAVENOUS; ORAL |
20250813 |
N/A |
NDA |
NDA210274 |
HIKMA PHARMACEUTICALS USA INC. |
VANCOMYCIN HYDROCHLORIDE |
769 mg/mg |
10 VIAL in 1 PACKAGE (0143-9473-10) / 769 mg in 1 VIAL (0143-9473-01) |
| 0143-9474-10 |
0143-9474 |
HUMAN PRESCRIPTION DRUG |
VANCOMYCIN HYDROCHLORIDE |
vancomycin hydrochloride |
INJECTION, POWDER, FOR SOLUTION |
INTRAVENOUS; ORAL |
20250813 |
N/A |
NDA |
NDA210274 |
HIKMA PHARMACEUTICALS USA INC. |
VANCOMYCIN HYDROCHLORIDE |
1280 mg/mg |
10 VIAL in 1 PACKAGE (0143-9474-10) / 1280 mg in 1 VIAL (0143-9474-01) |
| 0143-9475-10 |
0143-9475 |
HUMAN PRESCRIPTION DRUG |
VANCOMYCIN HYDROCHLORIDE |
vancomycin hydrochloride |
INJECTION, POWDER, FOR SOLUTION |
INTRAVENOUS; ORAL |
20250813 |
N/A |
NDA |
NDA210274 |
HIKMA PHARMACEUTICALS USA INC. |
VANCOMYCIN HYDROCHLORIDE |
1540 mg/mg |
10 VIAL in 1 PACKAGE (0143-9475-10) / 1540 mg in 1 VIAL (0143-9475-01) |