Topotecan Hydrochloride
These highlights do not include all the information needed to use TOPOTECAN HYDROCHLORIDE FOR INJECTION safely and effectively. See full prescribing information for TOPOTECAN HYDROCHLORIDE FOR INJECTION. TOPOTECAN HYDROCHLORIDE for injection, for intravenous use Initial U.S. Approval: 1996
Approved
Approval ID
b6019088-cd94-43b4-b5ce-ba20b6b8021e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 18, 2020
Manufacturers
FDA
Fresenius Kabi USA, LLC
DUNS: 608775388
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
TOPOTECAN HYDROCHLORIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63323-762
Application NumberANDA091089
Product Classification
M
Marketing Category
C73584
G
Generic Name
TOPOTECAN HYDROCHLORIDE
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateDecember 31, 2019
FDA Product Classification
INGREDIENTS (5)
MANNITOLInactive
Quantity: 48 mg in 4 mL
Code: 3OWL53L36A
Classification: IACT
TARTARIC ACIDInactive
Quantity: 20 mg in 4 mL
Code: W4888I119H
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
TOPOTECAN HYDROCHLORIDEActive
Quantity: 4 mg in 4 mL
Code: 956S425ZCY
Classification: ACTIM