HYCAMTIN
These highlights do not include all the information needed to use HYCAMTIN FOR INJECTION safely and effectively. See full prescribing information for HYCAMTIN FOR INJECTION. HYCAMTIN (topotecan) for injection, for intravenous useInitial U.S. Approval: 1996
Approved
Approval ID
eeee060c-a9ec-423e-a374-8484009f8524
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 7, 2022
Manufacturers
FDA
Novartis Pharmaceuticals Corporation
DUNS: 002147023
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
NDC Product Code0078-0674
Application NumberNDA020671
Marketing CategoryC73594
Route of AdministrationINTRAVENOUS
Effective DateJuly 4, 2015
Generic Nametopotecan hydrochloride
INGREDIENTS (5)
TOPOTECAN HYDROCHLORIDEActive
Quantity: 4 mg in 4 mL
Code: 956S425ZCY
Classification: ACTIM
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
TARTARIC ACIDInactive
Code: W4888I119H
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT