Irinotecan Hydrochloride

Product NDC

0703-4434

11-digit product format

007034434

Labeler code

0703

Product ID

0703-4434_ddf159b7-99ae-4fef-8026-f9ffb4b879c8

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Irinotecan Hydrochloride

Dosage form

INJECTION, SOLUTION

Route

INTRAVENOUS

Labeler

Teva Parenteral Medicines, Inc.

Application

ANDA090101

Marketing category

ANDA

Marketing start

2015-07-01

Marketing end

2019-06-30

Substance

IRINOTECAN HYDROCHLORIDE

Active strength

100 mg/5mL

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