| NDC Code: |
42236-001 |
| Proprietary Name: |
Gemcitabine Hydrochloride |
| Suffix: |
|
| Non-Proprietary Name: |
gemcitabine hydrochloride |
| Dosage Form: |
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION |
| Method: |
INTRAVENOUS |
| Original Marketing Date: |
20-09-2012 |
| Category Name: |
ANDA |
| Application Number: |
ANDA090663 |
| Labeler: |
HAMELN RDS GMBH |
| 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: |
|
