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FDA Product

MenQuadfi

Product approved by U.S. Food and Drug Administration (US)

Basic Information

MenQuadfi

49281-590

Regulatory Information

49281-590

BLA125701

C73585

May 23, 2025

USA

These highlights do not include all the information needed to use MENQUADFI® safely and effectively. See full prescribing information for MENQUADFI. MenQuadfi, Meningococcal (Groups A, C, Y, W) Conjugate Vaccine injection, for intramuscular use Initial U.S. Approval: 2020

VACCINE LABEL

14

Company Information

086723285

Active Ingredients

NEISSERIA MENINGITIDIS GROUP A CAPSULAR POLYSACCHARIDE TETANUS TOXOID CONJUGATE ANTIGEN

Quantity: 10 ug in 0.5 mL

Code: T4GYX3110D

Class Code: ACTIB

NEISSERIA MENINGITIDIS GROUP C CAPSULAR POLYSACCHARIDE TETANUS TOXOID CONJUGATE ANTIGEN

Quantity: 10 ug in 0.5 mL

Code: ZT89E5A103

Class Code: ACTIB

NEISSERIA MENINGITIDIS GROUP Y CAPSULAR POLYSACCHARIDE TETANUS TOXOID CONJUGATE ANTIGEN

Quantity: 10 ug in 0.5 mL

Code: 4WAN8PQK15

Class Code: ACTIB

SODIUM CHLORIDE

Quantity: 3.35 mg in 0.5 mL

Code: 451W47IQ8X

Class Code: IACT

SODIUM ACETATE ANHYDROUS

Quantity: 1.23 mg in 0.5 mL

Code: NVG71ZZ7P0

Class Code: IACT

WATER

Code: 059QF0KO0R

Class Code: IACT

Active Moieties

NEISSERIA MENINGITIDIS GROUP A CAPSULAR POLYSACCHARIDE TETANUS TOXOID CONJUGATE ANTIGEN

Code: T4GYX3110D

NEISSERIA MENINGITIDIS GROUP C CAPSULAR POLYSACCHARIDE TETANUS TOXOID CONJUGATE ANTIGEN

Code: ZT89E5A103

NEISSERIA MENINGITIDIS GROUP Y CAPSULAR POLYSACCHARIDE TETANUS TOXOID CONJUGATE ANTIGEN

Code: 4WAN8PQK15

NEISSERIA MENINGITIDIS GROUP W-135 CAPSULAR POLYSACCHARIDE TETANUS TOXOID CONJUGATE ANTIGEN

Code: L77OK410KW

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