MedPath
FDA Product

TUBERSOL

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

Basic Information

TUBERSOL

49281-752

Regulatory Information

49281-752

BLA103941

C73585

January 25, 2024

USA

Tuberculin Purified Protein Derivative(Mantoux)TUBERSOL

HUMAN PRESCRIPTION DRUG LABEL

16

Company Information

086723285

Active Ingredients

Tuberculin Purified Protein Derivative

Quantity: 5 [iU] in 0.1 mL

Code: I7L8FKN87J

Class Code: ACTIB

Phenol

Quantity: 0.35 mg in 0.1 mL

Code: 339NCG44TV

Class Code: IACT

Polysorbate 80

Quantity: 0.0125 uL in 0.1 mL

Code: 6OZP39ZG8H

Class Code: IACT

Active Moieties

Tuberculin Purified Protein Derivative

Code: I7L8FKN87J

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