FLUCELVAX QUADRIVALENT (PREFILLED SYRINGE)

Product NDC

70461-318

11-digit product format

704610318

Labeler code

70461

Product ID

70461-318_517e03e0-dd10-491b-8524-9fba6e679515

Type

VACCINE

Nonproprietary name

INFLUENZA A VIRUS A/SINGAPORE/GP1908/2015 IVR-180 (H1N1) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED), INFLUENZA A VIRUS A/NORTH CAROLINA/04/2016 (H3N2) HEMAGGLUTININ ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED), INFLUENZA B VIRUS B/IOWA/06/2017 HEMAGGLUTININ ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED), INFLUENZA B VIRUS B/SINGAPORE/INFTT-16-0610/2016 HEMAGGLUTININ ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED)

Dosage form

INJECTION, SUSPENSION

Route

INTRAMUSCULAR

Labeler

Seqirus, Inc.

Application

BLA125408

Marketing category

BLA

Marketing start

2016-05-23

Marketing end

0000-00-00

Substance

INFLUENZA A VIRUS A/SINGAPORE/GP1908/2015 IVR-180 (H1N1) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED); INFLUENZA A VIRUS A/NORTH CAROLINA/04/2016 (H3N2) HEMAGGLUTININ ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED); INFLUENZA B VIRUS B/IOWA/06/2017 HEMAGGLUTININ ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED); INFLUENZA B VIRUS B/SINGAPORE/INFTT-16-0610/2016 HEMAGGLUTININ ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED)

Active strength

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

NDC exclude flag

No

Listing certified through

2019-12-31

Current FDA listing

Historical FDA.report record