Aspergillus fumigatus
Allergenic Extract
Approved
Approval ID
8559987a-4127-45d1-81c8-9bce75e85db3
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 14, 2009
Manufacturers
FDA
Nelco Laboratories, Inc.
DUNS: 054980867
Products 10
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Wheat Stem Rust
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code36987-2185
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
Wheat Stem Rust
Product Specifications
Route of AdministrationSUBCUTANEOUS, INTRADERMAL
Effective DateDecember 14, 2009
FDA Product Classification
INGREDIENTS (5)
PUCCINIA GRAMINISActive
Quantity: 40000 [PNU] in 1 mL
Code: O0HJ02QBWN
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Curvularia inaequalis
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code36987-1960
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
Curvularia inaequalis
Product Specifications
Route of AdministrationSUBCUTANEOUS, INTRADERMAL
Effective DateDecember 14, 2009
FDA Product Classification
INGREDIENTS (5)
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
CURVULARIA INAEQUALISActive
Quantity: 40000 [PNU] in 1 mL
Code: W042YAB8JC
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Phoma glomerata
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code36987-2059
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
Phoma glomerata
Product Specifications
Route of AdministrationINTRADERMAL, SUBCUTANEOUS
Effective DateDecember 14, 2009
FDA Product Classification
INGREDIENTS (5)
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
PHOMA GLOMERATAActive
Quantity: 40000 [PNU] in 1 mL
Code: UPX000VMIF
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
Fusarium compactum
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code36987-1978
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
Fusarium compactum
Product Specifications
Route of AdministrationSUBCUTANEOUS, INTRADERMAL
Effective DateDecember 14, 2009
FDA Product Classification
INGREDIENTS (5)
FUSARIUM COMPACTUMActive
Quantity: 40000 [PNU] in 1 mL
Code: V4OQR60A5P
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Wheat Smut
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code36987-2167
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
Wheat Smut
Product Specifications
Route of AdministrationSUBCUTANEOUS, INTRADERMAL
Effective DateDecember 14, 2009
FDA Product Classification
INGREDIENTS (5)
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
USTILAGO TRITICIActive
Quantity: 40000 [PNU] in 1 mL
Code: BV82OL2IZ8
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Wheat Bunt
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code36987-2176
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
Wheat Bunt
Product Specifications
Route of AdministrationINTRADERMAL, SUBCUTANEOUS
Effective DateDecember 14, 2009
FDA Product Classification
INGREDIENTS (5)
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
TILLETIA CARIESActive
Quantity: 40000 [PNU] in 1 mL
Code: C7000B9PQI
Classification: ACTIB
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Bipolaris sorokiniana
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code36987-1996
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
Bipolaris sorokiniana
Product Specifications
Route of AdministrationSUBCUTANEOUS, INTRADERMAL
Effective DateDecember 14, 2009
FDA Product Classification
INGREDIENTS (5)
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
COCHLIOBOLUS SATIVUSActive
Quantity: 40000 [PNU] in 1 mL
Code: 3LN5B70U4W
Classification: ACTIB
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Trichophyton mentagrophytes
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code36987-2131
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
Trichophyton mentagrophytes
Product Specifications
Route of AdministrationSUBCUTANEOUS, INTRADERMAL
Effective DateDecember 14, 2009
FDA Product Classification
INGREDIENTS (5)
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
TRICHOPHYTON MENTAGROPHYTESActive
Quantity: 40000 [PNU] in 1 mL
Code: 199I7J3JIV
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Corn Smut
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code36987-2149
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
Corn Smut
Product Specifications
Route of AdministrationSUBCUTANEOUS, INTRADERMAL
Effective DateDecember 14, 2009
FDA Product Classification
INGREDIENTS (5)
USTILAGO MAYDISActive
Quantity: 40000 [PNU] in 1 mL
Code: 4K7Z7K7SWG
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
Oat Smut
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code36987-2158
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
Oat Smut
Product Specifications
Route of AdministrationSUBCUTANEOUS, INTRADERMAL
Effective DateDecember 14, 2009
FDA Product Classification
INGREDIENTS (5)
USTILAGO AVENAEActive
Quantity: 40000 [PNU] in 1 mL
Code: YIH315U1TU
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT