MedPath
FDA Product

Aplisol

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

Basic Information

Aplisol

64725-0104

Regulatory Information

64725-0104

BLA103782

C73585

July 9, 2015

USA

APLISOL (Tuberculin Purified Protein Derivative, Diluted [Stabilized Solution])

HUMAN PRESCRIPTION DRUG LABEL

3

Company Information

TYA Pharmaceuticals

938389038

Active Ingredients

Polysorbate 80

Code: 6OZP39ZG8H

Class Code: IACT

Phenol

Code: 339NCG44TV

Class Code: IACT

Tuberculin Purified Protein Derivative

Quantity: 5 [iU] in 0.1 mL

Code: I7L8FKN87J

Class Code: ACTIB

Active Moieties

tuberculin Purified Protein Derivative

Code: I7L8FKN87J

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