| NDC Code: |
0781-3282 |
| Proprietary Name: |
Gemcitabine HCl |
| Suffix: |
|
| Non-Proprietary Name: |
Gemcitabine hydrochloride |
| Dosage Form: |
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION |
| Method: |
INTRAVENOUS |
| Original Marketing Date: |
27-08-2010 |
| End of Marketing: |
30-06-2014 |
| Category Name: |
NDA |
| Application Number: |
NDA020509 |
| Labeler: |
SANDOZ INC |
| Substance Name: |
GEMCITABINE HYDROCHLORIDE |
| Active Numerator Strength: |
200 |
| Active Ingredient Unit: |
mg/5mL |
| Pharm Classes: |
Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] |
| DEA Schedule: |
|
