75833-601-01 |
75833-601 |
HUMAN PRESCRIPTION DRUG |
Hepzato Kit |
melphalan hydrochloride injection, powder, lyophilized, for solution |
KIT |
INTRA-ARTERIAL |
20231204 |
N/A |
NDA |
NDA201848 |
Delcath Systems, Inc. |
|
|
1 KIT in 1 BOX (75833-601-01) * 5 VIAL, SINGLE-USE in 1 BOX (75833-700-01) / 10 mL in 1 VIAL, SINGLE-USE * 2 BAG in 1 BOX (75833-444-01) / 250 mL in 1 BAG * 5 VIAL, SINGLE-USE in 1 BOX (75833-800-01) / 10 mL in 1 VIAL, SINGLE-USE |
75833-601-02 |
75833-601 |
HUMAN PRESCRIPTION DRUG |
Hepzato Kit |
melphalan hydrochloride injection, powder, lyophilized, for solution |
KIT |
INTRA-ARTERIAL |
20231204 |
N/A |
NDA |
NDA201848 |
Delcath Systems, Inc. |
|
|
1 KIT in 1 BOX (75833-601-02) * 5 VIAL, SINGLE-USE in 1 BOX (75833-700-01) / 10 mL in 1 VIAL, SINGLE-USE * 2 BAG in 1 BOX (75833-444-01) / 250 mL in 1 BAG * 5 VIAL, SINGLE-USE in 1 BOX (75833-800-01) / 10 mL in 1 VIAL, SINGLE-USE |
75833-601-07 |
75833-601 |
HUMAN PRESCRIPTION DRUG |
Hepzato Kit |
melphalan hydrochloride injection, powder, lyophilized, for solution |
KIT |
INTRA-ARTERIAL |
20231204 |
N/A |
NDA |
NDA201848 |
Delcath Systems, Inc. |
|
|
1 KIT in 1 BOX (75833-601-07) * 5 VIAL, SINGLE-USE in 1 BOX (75833-700-01) / 10 mL in 1 VIAL, SINGLE-USE * 2 BAG in 1 BOX (75833-444-01) / 250 mL in 1 BAG * 5 VIAL, SINGLE-USE in 1 BOX (75833-800-01) / 10 mL in 1 VIAL, SINGLE-USE |
75833-601-08 |
75833-601 |
HUMAN PRESCRIPTION DRUG |
Hepzato Kit |
melphalan hydrochloride injection, powder, lyophilized, for solution |
KIT |
INTRA-ARTERIAL |
20231204 |
N/A |
NDA |
NDA201848 |
Delcath Systems, Inc. |
|
|
1 KIT in 1 BOX (75833-601-08) * 5 VIAL, SINGLE-USE in 1 BOX (75833-700-01) / 10 mL in 1 VIAL, SINGLE-USE * 2 BAG in 1 BOX (75833-444-01) / 250 mL in 1 BAG * 5 VIAL, SINGLE-USE in 1 BOX (75833-800-01) / 10 mL in 1 VIAL, SINGLE-USE |