House Dust
Allergenic Extract
Approved
Approval ID
d47f69c2-ff46-48fa-9398-aeab1496b6bb
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 10, 2009
Manufacturers
FDA
Nelco Laboratories, Inc.
DUNS: 054980867
Products 8
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
House Dust
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code36987-1124
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
House Dust
Product Specifications
Route of AdministrationINTRADERMAL, SUBCUTANEOUS
Effective DateDecember 10, 2009
FDA Product Classification
INGREDIENTS (5)
HOUSE DUSTActive
Quantity: 20000 [PNU] in 1 mL
Code: EYO007VX98
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
House Dust
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code36987-1129
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
House Dust
Product Specifications
Route of AdministrationINTRADERMAL, SUBCUTANEOUS
Effective DateDecember 10, 2009
FDA Product Classification
INGREDIENTS (5)
HOUSE DUSTActive
Quantity: 0.1 g in 1 mL
Code: EYO007VX98
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
House Dust
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code36987-1123
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
House Dust
Product Specifications
Route of AdministrationINTRADERMAL, SUBCUTANEOUS
Effective DateDecember 10, 2009
FDA Product Classification
INGREDIENTS (6)
HOUSE DUSTActive
Quantity: 10000 [PNU] in 1 mL
Code: EYO007VX98
Classification: ACTIB
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
House Dust
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code36987-1127
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
House Dust
Product Specifications
Route of AdministrationINTRADERMAL, SUBCUTANEOUS
Effective DateDecember 10, 2009
FDA Product Classification
INGREDIENTS (5)
HOUSE DUSTActive
Quantity: 0.05 g in 1 mL
Code: EYO007VX98
Classification: ACTIB
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
House Dust
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code36987-1125
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
House Dust
Product Specifications
Route of AdministrationINTRADERMAL, SUBCUTANEOUS
Effective DateDecember 10, 2009
FDA Product Classification
INGREDIENTS (6)
HOUSE DUSTActive
Quantity: 20000 [PNU] in 1 mL
Code: EYO007VX98
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
House Dust
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code36987-1126
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
House Dust
Product Specifications
Route of AdministrationINTRADERMAL, SUBCUTANEOUS
Effective DateDecember 10, 2009
FDA Product Classification
INGREDIENTS (5)
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
HOUSE DUSTActive
Quantity: 40000 [PNU] in 1 mL
Code: EYO007VX98
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
House Dust
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code36987-1128
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
House Dust
Product Specifications
Route of AdministrationINTRADERMAL, SUBCUTANEOUS
Effective DateDecember 10, 2009
FDA Product Classification
INGREDIENTS (6)
HOUSE DUSTActive
Quantity: 0.05 g in 1 mL
Code: EYO007VX98
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
House Dust
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code36987-1122
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
House Dust
Product Specifications
Route of AdministrationINTRADERMAL, SUBCUTANEOUS
Effective DateDecember 10, 2009
FDA Product Classification
INGREDIENTS (5)
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
HOUSE DUSTActive
Quantity: 10000 [PNU] in 1 mL
Code: EYO007VX98
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT