MedPath

Cattle Epithelium

Allergenic Extract

Approved
Approval ID

68a04179-30a6-4067-8585-c28e4924d578

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.

Goose Feathers

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code36987-1034
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: 10000 [PNU] in 1 mL
Code: 15XI414745
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT

Rat Epithelium

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code36987-1106
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)

SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
RATTUS NORVEGICUS SKINActive
Quantity: 10000 [PNU] in 1 mL
Code: Y69HPD48AI
Classification: ACTIB
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT

Duck Feathers

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code36987-1026
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
Duck Feathers
Product Specifications
Route of AdministrationINTRADERMAL, SUBCUTANEOUS
Effective DateDecember 3, 2009
FDA Product Classification

INGREDIENTS (6)

ANAS PLATYRHYNCHOS FEATHERActive
Quantity: 10000 [PNU] in 1 mL
Code: 83B65P4796
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

Rabbit Epithelium

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code36987-1098
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)

ORYCTOLAGUS CUNICULUS SKINActive
Quantity: 10000 [PNU] in 1 mL
Code: Z91WAU43WC
Classification: ACTIB
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT

Hog Epithelium

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code36987-1074
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)

SUS SCROFA SKINActive
Quantity: 10000 [PNU] in 1 mL
Code: 3EM4VW6TQN
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

Goat Epithelium

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code36987-1050
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 (6)

SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
CAPRA HIRCUS SKINActive
Quantity: 10000 [PNU] in 1 mL
Code: JLG9853E2P
Classification: ACTIB
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT

Horse Epithelium

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code36987-1082
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)

SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
EQUUS CABALLUS SKINActive
Quantity: 10000 [PNU] in 1 mL
Code: 88VZV9HGT4
Classification: ACTIB
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT

Gerbil Epithelium

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code36987-1042
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 (6)

MERIONES UNGUICULATUS SKINActive
Quantity: 10000 [PNU] in 1 mL
Code: 9WN2H714TG
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

Mouse Epithelium

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code36987-1090
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
MUS MUSCULUS SKINActive
Quantity: 10000 [PNU] in 1 mL
Code: 390AN9GB09
Classification: ACTIB
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT

Dog Epithelium

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code36987-1010
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 (6)

CANIS LUPUS FAMILIARIS SKINActive
Quantity: 10000 [PNU] in 1 mL
Code: X2W7CLE97T
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT

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