SYLVANT

Product NDC

57894-421

11-digit product format

578940421

Labeler code

57894

Product ID

57894-421_7c319292-67e4-11e9-a1df-32bf0099106d

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

siltuximab

Dosage form

INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

Route

INTRAVENOUS

Labeler

Janssen Biotech, Inc.

Application

BLA125496

Marketing category

BLA

Marketing start

2014-04-01

Marketing end

2021-01-31

Substance

SILTUXIMAB

Active strength

400 mg/1

Pharmacologic classes

Interleukin-6 Antagonist [EPC],Interleukin-6 Antagonists [MoA]

NDC exclude flag

No

Listing certified through

0000-00-00

Current FDA listing

Historical FDA.report record