42023-622-01 |
42023-622 |
HUMAN PRESCRIPTION DRUG |
Bivalirudin |
Bivalirudin |
INJECTION, SOLUTION |
INTRAVENOUS |
20230619 |
N/A |
NDA |
NDA211215 |
Par Pharmaceutical, 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 |
Par Pharmaceutical, Inc. |
BIVALIRUDIN |
250 mg/1 |
10 VIAL, SINGLE-DOSE in 1 CARTON (42023-622-10) / 1 INJECTION, SOLUTION in 1 VIAL, SINGLE-DOSE |
70860-403-51 |
70860-403 |
HUMAN PRESCRIPTION DRUG |
Bivalirudin RTU |
bivalirudin |
INJECTION, SOLUTION |
INTRAVENOUS |
20200301 |
20240626 |
NDA |
NDA211215 |
Athenex Pharmaceutical Division, LLC. |
BIVALIRUDIN |
5 mg/mL |
10 CARTON in 1 CARTON (70860-403-51) / 1 VIAL, SINGLE-DOSE in 1 CARTON (70860-403-50) / 50 mL in 1 VIAL, SINGLE-DOSE |
70511-141-84 |
70511-141 |
HUMAN PRESCRIPTION DRUG |
Angiomax RTU |
bivalirudin |
INJECTION, SOLUTION |
INTRAVENOUS |
20190808 |
N/A |
NDA |
NDA211215 |
MAIA Pharmaceuticals, Inc. |
BIVALIRUDIN |
250 mg/1 |
1 VIAL in 1 PACKAGE (70511-141-84) / 10 INJECTION, SOLUTION in 1 VIAL |
70511-141-50 |
70511-141 |
HUMAN PRESCRIPTION DRUG |
Angiomax RTU |
bivalirudin |
INJECTION, SOLUTION |
INTRAVENOUS |
20190808 |
N/A |
NDA |
NDA211215 |
MAIA Pharmaceuticals, Inc. |
BIVALIRUDIN |
250 mg/1 |
1 INJECTION, SOLUTION in 1 CARTON (70511-141-50) |