Cattle Epithelium
Allergenic Extract
Approved
Approval ID
08ccc1dd-6386-4a20-8899-64c46b4206d5
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 3, 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.
Horse Epithelium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code36987-1085
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
Horse Epithelium
Product Specifications
Route of AdministrationINTRADERMAL, SUBCUTANEOUS
Effective DateDecember 3, 2009
FDA Product Classification
INGREDIENTS (5)
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
EQUUS CABALLUS SKINActive
Quantity: 0.05 g in 1 mL
Code: 88VZV9HGT4
Classification: ACTIB
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Rabbit Epithelium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code36987-1101
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
Rabbit Epithelium
Product Specifications
Route of AdministrationINTRADERMAL, SUBCUTANEOUS
Effective DateDecember 3, 2009
FDA Product Classification
INGREDIENTS (5)
ORYCTOLAGUS CUNICULUS SKINActive
Quantity: 0.05 g in 1 mL
Code: Z91WAU43WC
Classification: ACTIB
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Rat Epithelium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code36987-1109
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
Rat Epithelium
Product Specifications
Route of AdministrationINTRADERMAL, SUBCUTANEOUS
Effective DateDecember 3, 2009
FDA Product Classification
INGREDIENTS (5)
RATTUS NORVEGICUS SKINActive
Quantity: 0.05 g in 1 mL
Code: Y69HPD48AI
Classification: ACTIB
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
Silk
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code36987-1117
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
Silk
Product Specifications
Route of AdministrationSUBCUTANEOUS, INTRADERMAL
Effective DateDecember 3, 2009
FDA Product Classification
INGREDIENTS (5)
BOMBYX MORI FIBERActive
Quantity: 0.05 g in 1 mL
Code: 6LK42KUV6W
Classification: ACTIB
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
Chicken Feathers
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code36987-1021
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
Chicken Feathers
Product Specifications
Route of AdministrationINTRADERMAL, SUBCUTANEOUS
Effective DateDecember 3, 2009
FDA Product Classification
INGREDIENTS (5)
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
GALLUS GALLUS FEATHERActive
Quantity: 0.05 g in 1 mL
Code: 1FCM16V0FV
Classification: ACTIB
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
Dog Epithelium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code36987-1013
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
Dog Epithelium
Product Specifications
Route of AdministrationINTRADERMAL, SUBCUTANEOUS
Effective DateDecember 3, 2009
FDA Product Classification
INGREDIENTS (5)
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
CANIS LUPUS FAMILIARIS SKINActive
Quantity: 0.05 g in 1 mL
Code: X2W7CLE97T
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Guinea Pig Epithelium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code36987-1061
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
Guinea Pig Epithelium
Product Specifications
Route of AdministrationINTRADERMAL, SUBCUTANEOUS
Effective DateDecember 3, 2009
FDA Product Classification
INGREDIENTS (5)
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
CAVIA PORCELLUS SKINActive
Quantity: 0.05 g in 1 mL
Code: GM3H4U6QS8
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
Hamster Epithelium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code36987-1069
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
Hamster Epithelium
Product Specifications
Route of AdministrationINTRADERMAL, SUBCUTANEOUS
Effective DateDecember 3, 2009
FDA Product Classification
INGREDIENTS (5)
MESOCRICETUS AURATUS SKINActive
Quantity: 0.05 g in 1 mL
Code: 3K873H631W
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
Goat Epithelium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code36987-1053
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
Goat Epithelium
Product Specifications
Route of AdministrationINTRADERMAL, SUBCUTANEOUS
Effective DateDecember 3, 2009
FDA Product Classification
INGREDIENTS (5)
CAPRA HIRCUS SKINActive
Quantity: 0.05 g in 1 mL
Code: JLG9853E2P
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Gerbil Epithelium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code36987-1045
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
Gerbil Epithelium
Product Specifications
Route of AdministrationINTRADERMAL, SUBCUTANEOUS
Effective DateDecember 3, 2009
FDA Product Classification
INGREDIENTS (5)
MERIONES UNGUICULATUS SKINActive
Quantity: 0.05 g in 1 mL
Code: 9WN2H714TG
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT