Gemcitabine Hydrochloride - Gemcitabine Hydrochloride
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Field |
Value |
NDC Code: |
63323-125 |
Proprietary Name: |
Gemcitabine Hydrochloride |
Suffix: |
|
Non-Proprietary Name: |
Gemcitabine Hydrochloride |
Dosage Form: |
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION |
Method: |
INTRAVENOUS |
Original Marketing Date: |
12-09-2011 |
Category Name: |
ANDA |
Application Number: |
ANDA077983 |
Labeler: |
APP PHARMACEUTICALS, LLC |
Substance Name: |
GEMCITABINE HYDROCHLORIDE |
Active Numerator Strength: |
1 |
Active Ingredient Unit: |
g/25mL |
Pharm Classes: |
Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] |
DEA Schedule: |
|