Aplisol
APLISOL (Tuberculin Purified Protein Derivative, Diluted [Stabilized Solution])
Approved
Approval ID
33ad349a-2969-4591-8c67-4d2a422a5ffb
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 9, 2015
Manufacturers
FDA
TYA Pharmaceuticals
DUNS: 938389038
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 Code64725-0104
Application NumberBLA103782
Product Classification
M
Marketing Category
C73585
G
Generic Name
Tuberculin Purified Protein Derivative
Product Specifications
Route of AdministrationINTRADERMAL
Effective DateJuly 9, 2015
FDA Product Classification
INGREDIENTS (3)
Polysorbate 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
PhenolInactive
Code: 339NCG44TV
Classification: IACT
Tuberculin Purified Protein DerivativeActive
Quantity: 5 [iU] in 0.1 mL
Code: I7L8FKN87J
Classification: ACTIB