Topotecan
These highlights do not include all the information needed to use TOPOTECAN INJECTION safely and effectively. See full prescribing information for TOPOTECAN INJECTION. TOPOTECAN injection, for intravenous use Initial U.S. Approval: 1996
Approved
Approval ID
1d4e1cce-c57e-4a8b-be96-f95a2778e221
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 1, 2021
Manufacturers
FDA
Hospira, Inc.
DUNS: 141588017
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
TOPOTECAN
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0409-0302
Application NumberNDA200582
Product Classification
M
Marketing Category
C73594
G
Generic Name
TOPOTECAN
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateDecember 31, 2019
FDA Product Classification
INGREDIENTS (5)
TOPOTECAN HYDROCHLORIDEActive
Quantity: 1 mg in 1 mL
Code: 956S425ZCY
Classification: ACTIM
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
TARTARIC ACIDInactive
Quantity: 5 mg in 1 mL
Code: W4888I119H
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT