topotecan

Product NDC

25021-236

11-digit product format

250210236

Labeler code

25021

Product ID

25021-236_9a438a29-0a0f-44e6-978c-32d098c41047

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

topotecan

Dosage form

INJECTION, SOLUTION, CONCENTRATE

Route

INTRAVENOUS

Labeler

Sagent Pharmaceuticals

Application

NDA022453

Marketing category

NDA

Marketing start

2014-12-15

Marketing end

2021-01-31

Substance

TOPOTECAN HYDROCHLORIDE

Active strength

1 mg/mL

Pharmacologic classes

Topoisomerase Inhibitor [EPC],Topoisomerase Inhibitors [MoA]

NDC exclude flag

No

Listing certified through

0000-00-00

Current FDA listing

Historical FDA.report record