Cattle Epithelium
Allergenic Extract
Approved
Approval ID
9f1e3612-f877-471c-88e0-41e41439ac15
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.
Hamster Epithelium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code36987-1070
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 (6)
MESOCRICETUS AURATUS SKINActive
Quantity: 0.05 g in 1 mL
Code: 3K873H631W
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
Horse Epithelium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code36987-1086
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 (6)
EQUUS CABALLUS SKINActive
Quantity: 0.05 g in 1 mL
Code: 88VZV9HGT4
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
Guinea Pig Epithelium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code36987-1062
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 (6)
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
CAVIA PORCELLUS SKINActive
Quantity: 0.05 g in 1 mL
Code: GM3H4U6QS8
Classification: ACTIB
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
Mouse Epithelium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code36987-1094
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
Mouse Epithelium
Product Specifications
Route of AdministrationINTRADERMAL, SUBCUTANEOUS
Effective DateDecember 3, 2009
FDA Product Classification
INGREDIENTS (6)
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
MUS MUSCULUS SKINActive
Quantity: 0.05 g in 1 mL
Code: 390AN9GB09
Classification: ACTIB
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
Hog Epithelium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code36987-1078
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
Hog Epithelium
Product Specifications
Route of AdministrationINTRADERMAL, SUBCUTANEOUS
Effective DateDecember 3, 2009
FDA Product Classification
INGREDIENTS (6)
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SUS SCROFA SKINActive
Quantity: 0.05 g in 1 mL
Code: 3EM4VW6TQN
Classification: ACTIB
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
Rabbit Epithelium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code36987-1102
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 (6)
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
ORYCTOLAGUS CUNICULUS SKINActive
Quantity: 0.05 g in 1 mL
Code: Z91WAU43WC
Classification: ACTIB
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
Rat Epithelium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code36987-1110
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 (6)
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
RATTUS NORVEGICUS SKINActive
Quantity: 0.05 g in 1 mL
Code: Y69HPD48AI
Classification: ACTIB
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
Silk
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code36987-1118
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
Silk
Product Specifications
Route of AdministrationINTRADERMAL, SUBCUTANEOUS
Effective DateDecember 3, 2009
FDA Product Classification
INGREDIENTS (6)
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
BOMBYX MORI FIBERActive
Quantity: 0.05 g in 1 mL
Code: 6LK42KUV6W
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
Cattle Epithelium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code36987-1006
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
Cattle Epithelium
Product Specifications
Route of AdministrationINTRADERMAL, SUBCUTANEOUS
Effective DateDecember 3, 2009
FDA Product Classification
INGREDIENTS (6)
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
BOS TAURUS SKINActive
Quantity: 0.05 g in 1 mL
Code: 7J12CD6O9L
Classification: ACTIB
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
Goose Feathers
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code36987-1038
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
Goose Feathers
Product Specifications
Route of AdministrationINTRADERMAL, SUBCUTANEOUS
Effective DateDecember 3, 2009
FDA Product Classification
INGREDIENTS (6)
ANSER ANSER FEATHERActive
Quantity: 0.05 g in 1 mL
Code: 15XI414745
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT