Sole
Allergenic Extract
Approved
Approval ID
5a47186d-964b-42e2-bc55-c18cd6fbc08f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 17, 2009
Manufacturers
FDA
Antigen Laboratories, Inc.
DUNS: 030705628
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Sole
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code49288-0473
Application NumberBLA102223
Product Classification
M
Marketing Category
C73585
G
Generic Name
Sole
Product Specifications
Route of AdministrationSUBCUTANEOUS, INTRADERMAL
Effective DateNovember 17, 2009
FDA Product Classification
INGREDIENTS (5)
ENGLISH SOLEActive
Quantity: 0.05 g in 1 mL
Code: 00CR8124AS
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
GLYCERINInactive
Quantity: 0.525 mL in 1 mL
Code: PDC6A3C0OX
Classification: IACT
SODIUM CHLORIDEInactive
Quantity: 0.0095 g in 1 mL
Code: 451W47IQ8X
Classification: IACT
SODIUM BICARBONATEInactive
Quantity: 0.0024 g in 1 mL
Code: 8MDF5V39QO
Classification: IACT