FLUARIX QUADRIVALENT

Product NDC

58160-898

11-digit product format

581600898

Labeler code

58160

Product ID

58160-898_5db26e22-e3ea-45df-9ab5-64073c20b012

Type

VACCINE

Nonproprietary name

influenza virus vaccine

Dosage form

SUSPENSION

Route

INTRAMUSCULAR

Labeler

GlaxoSmithKline Biologicals SA

Application

BLA125127

Marketing category

BLA

Marketing start

2018-06-29

Marketing end

2019-06-30

Substance

INFLUENZA A VIRUS A/SINGAPORE/GP1908/2015 IVR-180 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/SINGAPORE/INFIMH-16-0019/2016 NIB-104 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/MARYLAND/15/2016 BX-69A ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED)

Active strength

15 ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL

NDC exclude flag

No

Listing certified through

0000-00-00

Current FDA listing

Historical FDA.report record