FDA Product

APLISOL

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

Basic Information

Product Name

APLISOL

FDA Product Code

50090-1336

Regulatory Information

NDC Product Code

50090-1336

Application Number

BLA103782

Marketing Category

C73585

Effective Date

November 1, 2017

Territorial Authority

USA

FDA Title

APLISOL

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

16

Company Information

ManufacturerA-S Medication Solutions

DUNS Number

830016429

Active Ingredients

TUBERCULIN PURIFIED PROTEIN DERIVATIVE

Quantity: 5 [iU] in 0.1 mL

Code: I7L8FKN87J

Class Code: ACTIB

POLYSORBATE 80

Code: 6OZP39ZG8H

Class Code: IACT

PHENOL

Code: 339NCG44TV

Class Code: IACT

Active Moieties

TUBERCULIN PURIFIED PROTEIN DERIVATIVE

Code: I7L8FKN87J

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