Aspergillus fumigatus
Allergenic Extract
Approved
Approval ID
182f7346-1f19-44b1-bc8f-d7c543a1c4dc
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 Bunt
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code36987-2172
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)
TILLETIA CARIESActive
Quantity: 10000 [PNU] in 1 mL
Code: C7000B9PQI
Classification: ACTIB
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
Fusarium compactum
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code36987-1974
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)
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
FUSARIUM COMPACTUMActive
Quantity: 10000 [PNU] in 1 mL
Code: V4OQR60A5P
Classification: ACTIB
Wheat Stem Rust
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code36987-2181
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: 10000 [PNU] in 1 mL
Code: O0HJ02QBWN
Classification: ACTIB
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Phoma glomerata
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code36987-2055
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)
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
PHOMA GLOMERATAActive
Quantity: 10000 [PNU] in 1 mL
Code: UPX000VMIF
Classification: ACTIB
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Curvularia inequalis
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code36987-1956
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 (5)
CURVULARIA INAEQUALISActive
Quantity: 10000 [PNU] in 1 mL
Code: W042YAB8JC
Classification: ACTIB
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
Stemphylium sarciniforms
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code36987-2109
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 (5)
STEMPHYLIUM SARCINIFORMEActive
Quantity: 10000 [PNU] in 1 mL
Code: XQ14H1462M
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 Code36987-2163
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)
USTILAGO TRITICIActive
Quantity: 10000 [PNU] in 1 mL
Code: BV82OL2IZ8
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
Saccharomyces cerevisiae
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code36987-2091
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
Saccharomyces cerevisiae
Product Specifications
Route of AdministrationSUBCUTANEOUS, INTRADERMAL
Effective DateDecember 14, 2009
FDA Product Classification
INGREDIENTS (5)
SACCHAROMYCES CEREVISIAEActive
Quantity: 10000 [PNU] in 1 mL
Code: 978D8U419H
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Rhodotorula mucilaginosa
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code36987-2082
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 (5)
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
RHODOTORULA MUCILAGINOSAActive
Quantity: 10000 [PNU] in 1 mL
Code: 62TY3X4N9Z
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
Penicilium chrysogenum
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code36987-2037
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
Penicilium chrysogenum
Product Specifications
Route of AdministrationSUBCUTANEOUS, INTRADERMAL
Effective DateDecember 14, 2009
FDA Product Classification
INGREDIENTS (5)
PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUMActive
Quantity: 10000 [PNU] in 1 mL
Code: 3Y1PE1GCIG
Classification: ACTIB
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT