MedPath
FDA Product

TUBERSOL

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

Basic Information

TUBERSOL

50090-1668

Regulatory Information

50090-1668

BLA103941

C73585

November 9, 2021

USA

Tuberculin Purified Protein Derivative(Mantoux)TUBERSOL

HUMAN PRESCRIPTION DRUG LABEL

12

Company Information

830016429

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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