| NDC Code: |
16729-151 |
| Proprietary Name: |
topotecan hydrochloride |
| Suffix: |
|
| Non-Proprietary Name: |
topotecan hydrochloride |
| Dosage Form: |
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION |
| Method: |
INTRAVENOUS |
| Original Marketing Date: |
01-07-2013 |
| Category Name: |
ANDA |
| Application Number: |
ANDA202351 |
| Labeler: |
ACCORD HEALTHCARE INC. |
| Substance Name: |
TOPOTECAN HYDROCHLORIDE |
| Active Numerator Strength: |
4 |
| Active Ingredient Unit: |
mg/4mL |
| Pharm Classes: |
Topoisomerase Inhibitor [EPC],Topoisomerase Inhibitors [MoA] |
| DEA Schedule: |
|
