Aplisol
APLISOL (Tuberculin Purified Protein Derivative, Diluted [Stabilized Solution])
Approved
Approval ID
1e91a67c-1694-4523-9548-58f7a8871134
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 31, 2017
Manufacturers
FDA
Par Pharmaceutical, Inc.
DUNS: 092733690
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 Code42023-104
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