NDC Code: |
0409-0185 |
Proprietary Name: |
Gemcitabine |
Suffix: |
|
Non-Proprietary Name: |
GEMCITABINE HYDROCHLORIDE |
Dosage Form: |
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION |
Method: |
INTRAVENOUS |
Original Marketing Date: |
25-07-2011 |
Category Name: |
ANDA |
Application Number: |
ANDA078339 |
Labeler: |
HOSPIRA, INC. |
Substance Name: |
GEMCITABINE HYDROCHLORIDE |
Active Numerator Strength: |
38 |
Active Ingredient Unit: |
mg/mL |
Pharm Classes: |
Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] |
DEA Schedule: |
|