| 42023-622-01 |
42023-622 |
HUMAN PRESCRIPTION DRUG |
Bivalirudin |
Bivalirudin |
INJECTION, SOLUTION |
INTRAVENOUS |
20230619 |
N/A |
NDA |
NDA211215 |
Endo USA, Inc. |
BIVALIRUDIN |
250 mg/1 |
1 VIAL, SINGLE-DOSE in 1 CARTON (42023-622-01) / 1 INJECTION, SOLUTION in 1 VIAL, SINGLE-DOSE |
| 42023-622-10 |
42023-622 |
HUMAN PRESCRIPTION DRUG |
Bivalirudin |
Bivalirudin |
INJECTION, SOLUTION |
INTRAVENOUS |
20230619 |
N/A |
NDA |
NDA211215 |
Endo USA, Inc. |
BIVALIRUDIN |
250 mg/1 |
10 VIAL, SINGLE-DOSE in 1 CARTON (42023-622-10) / 1 INJECTION, SOLUTION in 1 VIAL, SINGLE-DOSE |
| 70511-142-50 |
70511-142 |
HUMAN PRESCRIPTION DRUG |
Bivalirudin |
Bivalirudin |
INJECTION, SOLUTION |
INTRAVENOUS |
20240527 |
N/A |
NDA |
NDA211215 |
MAIA Pharmaceuticals, Inc. |
BIVALIRUDIN |
250 mg/1 |
1 VIAL, SINGLE-DOSE in 1 CARTON (70511-142-50) / 1 INJECTION, SOLUTION in 1 VIAL, SINGLE-DOSE |
| 70511-142-84 |
70511-142 |
HUMAN PRESCRIPTION DRUG |
Bivalirudin |
Bivalirudin |
INJECTION, SOLUTION |
INTRAVENOUS |
20240527 |
N/A |
NDA |
NDA211215 |
MAIA Pharmaceuticals, Inc. |
BIVALIRUDIN |
250 mg/1 |
10 VIAL, SINGLE-DOSE in 1 CARTON (70511-142-84) / 1 INJECTION, SOLUTION in 1 VIAL, SINGLE-DOSE |