A. Dust
Allergenic Extract
Approved
Approval ID
1a99af9f-2e6b-432b-8fe5-a40dc468242b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 16, 2009
Manufacturers
FDA
Antigen Laboratories, Inc.
DUNS: 030705628
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Mattress Dust
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code49288-0315
Application NumberBLA102223
Product Classification
M
Marketing Category
C73585
G
Generic Name
Mattress Dust
Product Specifications
Route of AdministrationSUBCUTANEOUS, INTRADERMAL
Effective DateNovember 16, 2009
FDA Product Classification
INGREDIENTS (5)
HOUSE DUSTActive
Quantity: 0.05 g in 1 mL
Code: EYO007VX98
Classification: ACTIB
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
WATERInactive
Code: 059QF0KO0R
Classification: IACT
House Dust
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code49288-0181
Application NumberBLA102223
Product Classification
M
Marketing Category
C73585
G
Generic Name
House Dust
Product Specifications
Route of AdministrationSUBCUTANEOUS, INTRADERMAL
Effective DateNovember 16, 2009
FDA Product Classification
INGREDIENTS (5)
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM CHLORIDEInactive
Quantity: 0.0095 g in 1 mL
Code: 451W47IQ8X
Classification: IACT
HOUSE DUSTActive
Quantity: 0.05 g in 1 mL
Code: EYO007VX98
Classification: ACTIB
SODIUM BICARBONATEInactive
Quantity: 0.0024 g in 1 mL
Code: 8MDF5V39QO
Classification: IACT
GLYCERINInactive
Quantity: 0.525 mL in 1 mL
Code: PDC6A3C0OX
Classification: IACT
House Dust
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code49288-0180
Application NumberBLA102223
Product Classification
M
Marketing Category
C73585
G
Generic Name
House Dust
Product Specifications
Route of AdministrationSUBCUTANEOUS, INTRADERMAL
Effective DateNovember 16, 2009
FDA Product Classification
INGREDIENTS (5)
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM BICARBONATEInactive
Quantity: 0.0024 g in 1 mL
Code: 8MDF5V39QO
Classification: IACT
HOUSE DUSTActive
Quantity: 0.1 g in 1 mL
Code: EYO007VX98
Classification: ACTIB
SODIUM CHLORIDEInactive
Quantity: 0.0095 g in 1 mL
Code: 451W47IQ8X
Classification: IACT
GLYCERINInactive
Quantity: 0.525 mL in 1 mL
Code: PDC6A3C0OX
Classification: IACT