68001-359-37 |
68001-359 |
HUMAN PRESCRIPTION DRUG |
GEMCITABINE |
GEMCITABINE |
INJECTION, SOLUTION |
INTRAVENOUS |
20180525 |
N/A |
NDA |
NDA209604 |
BluePoint Laboratories |
GEMCITABINE HYDROCHLORIDE |
100 mg/mL |
1 VIAL, MULTI-DOSE in 1 CARTON (68001-359-37) / 20 mL in 1 VIAL, MULTI-DOSE |
16729-391-30 |
16729-391 |
HUMAN PRESCRIPTION DRUG |
GEMCITABINE |
GEMCITABINE |
INJECTION, SOLUTION |
INTRAVENOUS |
20180124 |
N/A |
NDA |
NDA209604 |
Accord Healthcare Inc. |
GEMCITABINE HYDROCHLORIDE |
100 mg/mL |
2 mL in 1 VIAL, MULTI-DOSE (16729-391-30) |
16729-423-33 |
16729-423 |
HUMAN PRESCRIPTION DRUG |
GEMCITABINE |
GEMCITABINE |
INJECTION, SOLUTION |
INTRAVENOUS |
20180124 |
N/A |
NDA |
NDA209604 |
Accord Healthcare Inc. |
GEMCITABINE HYDROCHLORIDE |
100 mg/mL |
15 mL in 1 VIAL, MULTI-DOSE (16729-423-33) |
16729-426-05 |
16729-426 |
HUMAN PRESCRIPTION DRUG |
GEMCITABINE |
GEMCITABINE |
INJECTION, SOLUTION |
INTRAVENOUS |
20180806 |
N/A |
NDA |
NDA209604 |
Accord Healthcare Inc. |
GEMCITABINE HYDROCHLORIDE |
100 mg/mL |
20 mL in 1 VIAL, MULTI-DOSE (16729-426-05) |
68001-348-36 |
68001-348 |
HUMAN PRESCRIPTION DRUG |
GEMCITABINE |
GEMCITABINE |
INJECTION, SOLUTION |
INTRAVENOUS |
20180525 |
N/A |
NDA |
NDA209604 |
BluePoint Laboratories |
GEMCITABINE HYDROCHLORIDE |
100 mg/mL |
1 VIAL, MULTI-DOSE in 1 CARTON (68001-348-36) / 10 mL in 1 VIAL, MULTI-DOSE |
68001-342-34 |
68001-342 |
HUMAN PRESCRIPTION DRUG |
GEMCITABINE |
GEMCITABINE |
INJECTION, SOLUTION |
INTRAVENOUS |
20180525 |
N/A |
NDA |
NDA209604 |
BluePoint Laboratories |
GEMCITABINE HYDROCHLORIDE |
100 mg/mL |
1 VIAL, MULTI-DOSE in 1 CARTON (68001-342-34) / 2 mL in 1 VIAL, MULTI-DOSE |
16729-419-03 |
16729-419 |
HUMAN PRESCRIPTION DRUG |
GEMCITABINE |
GEMCITABINE |
INJECTION, SOLUTION |
INTRAVENOUS |
20180125 |
N/A |
NDA |
NDA209604 |
Accord Healthcare Inc. |
GEMCITABINE HYDROCHLORIDE |
100 mg/mL |
10 mL in 1 VIAL, MULTI-DOSE (16729-419-03) |