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APLISOL

APLISOL

Approved
Approval ID

9f025046-850f-46c1-bdfd-245032144307

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

May 9, 2023

Manufacturers
FDA

A-S Medication Solutions

DUNS: 830016429

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Tuberculin Purified Protein Derivative

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code50090-1336
Application NumberBLA103782
Product Classification
M
Marketing Category
C73585
G
Generic Name
Tuberculin Purified Protein Derivative
Product Specifications
Route of AdministrationINTRADERMAL
Effective DateNovember 1, 2017
FDA Product Classification

INGREDIENTS (3)

TUBERCULIN PURIFIED PROTEIN DERIVATIVEActive
Quantity: 5 [iU] in 0.1 mL
Code: I7L8FKN87J
Classification: ACTIB
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT

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APLISOL - FDA Drug Approval Details