BENDAMUSTINE HYDROCHLORIDE

Product NDC

42367-520

11-digit product format

423670520

Labeler code

42367

Product ID

42367-520_d59adc7a-6b2a-45ec-961b-d8a99f6d3933

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

bendamustine hydrochloride

Dosage form

INJECTION

Route

INTRAVENOUS

Labeler

Eagle Pharmaceuticals, Inc

Application

NDA205580

Marketing category

NDA

Marketing start

2018-05-15

Marketing end

2020-09-30

Substance

BENDAMUSTINE HYDROCHLORIDE

Active strength

100 mg/1

Pharmacologic classes

Alkylating Activity [MoA],Alkylating Drug [EPC]

NDC exclude flag

No

Listing certified through

0000-00-00

Current FDA listing

Historical FDA.report record