Aspergillus fumigatus
Allergenic Extract
Approved
Approval ID
cd1c8eb7-3b26-4767-b638-b795140a9242
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.
Phoma glomerata
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code36987-2058
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 (6)
PHOMA GLOMERATAActive
Quantity: 20000 [PNU] in 1 mL
Code: UPX000VMIF
Classification: ACTIB
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
Curvularia inequalis
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code36987-1959
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
Curvularia inequalis
Product Specifications
Route of AdministrationSUBCUTANEOUS, INTRADERMAL
Effective DateDecember 14, 2009
FDA Product Classification
INGREDIENTS (6)
CURVULARIA INAEQUALISActive
Quantity: 20000 [PNU] in 1 mL
Code: W042YAB8JC
Classification: ACTIB
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
Wheat Bunt
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code36987-2175
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 (6)
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
TILLETIA CARIESActive
Quantity: 20000 [PNU] in 1 mL
Code: C7000B9PQI
Classification: ACTIB
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
Fusarium compactum
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code36987-1977
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 (6)
FUSARIUM COMPACTUMActive
Quantity: 20000 [PNU] in 1 mL
Code: V4OQR60A5P
Classification: ACTIB
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
Rhizopus oryzae
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code36987-2076
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
Rhizopus oryzae
Product Specifications
Route of AdministrationSUBCUTANEOUS, INTRADERMAL
Effective DateDecember 14, 2009
FDA Product Classification
INGREDIENTS (6)
RHIZOPUS ARRHIZUS VAR. ARRHIZUSActive
Quantity: 20000 [PNU] in 1 mL
Code: 8476849N1Y
Classification: ACTIB
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Rhodotorula mucilaginosa
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code36987-2085
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
Rhodotorula mucilaginosa
Product Specifications
Route of AdministrationSUBCUTANEOUS, INTRADERMAL
Effective DateDecember 14, 2009
FDA Product Classification
INGREDIENTS (6)
RHODOTORULA MUCILAGINOSAActive
Quantity: 20000 [PNU] in 1 mL
Code: 62TY3X4N9Z
Classification: ACTIB
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
Trichophyton mentagrophytes
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code36987-2130
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 (6)
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
TRICHOPHYTON MENTAGROPHYTESActive
Quantity: 20000 [PNU] in 1 mL
Code: 199I7J3JIV
Classification: ACTIB
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
Trichoderma harzianam
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code36987-2121
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
Trichoderma harzianam
Product Specifications
Route of AdministrationSUBCUTANEOUS, INTRADERMAL
Effective DateDecember 14, 2009
FDA Product Classification
INGREDIENTS (6)
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
TRICHODERMA HARZIANUMActive
Quantity: 20000 [PNU] in 1 mL
Code: CA33Q4013Q
Classification: ACTIB
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
Stemphylium sarciniforms
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code36987-2112
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
Stemphylium sarciniforms
Product Specifications
Route of AdministrationINTRADERMAL, SUBCUTANEOUS
Effective DateDecember 14, 2009
FDA Product Classification
INGREDIENTS (6)
STEMPHYLIUM SARCINIFORMEActive
Quantity: 20000 [PNU] in 1 mL
Code: XQ14H1462M
Classification: ACTIB
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Wheat Stem Rust
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code36987-2184
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 (6)
PUCCINIA GRAMINISActive
Quantity: 20000 [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
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT