Topotecan hydrochloride - Topotecan hydrochloride
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Field |
Value |
NDC Code: |
62756-023 |
Proprietary Name: |
Topotecan hydrochloride |
Suffix: |
|
Non-Proprietary Name: |
Topotecan hydrochloride |
Dosage Form: |
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION |
Method: |
INTRAVENOUS |
Original Marketing Date: |
31-08-2013 |
Category Name: |
ANDA |
Application Number: |
ANDA202203 |
Labeler: |
SUN PHARMACEUTICAL INDUSTRIES LIMITED |
Substance Name: |
TOPOTECAN HYDROCHLORIDE |
Active Numerator Strength: |
4 |
Active Ingredient Unit: |
mg/4mL |
Pharm Classes: |
Topoisomerase Inhibitor [EPC],Topoisomerase Inhibitors [MoA] |
DEA Schedule: |
|