MedPath

Cattle Epithelium

Allergenic Extract

Approved
Approval ID

f1eabfd7-c87c-4123-822a-0bcf9f890fa2

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 Code36987-1088
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: 0.1 g in 1 mL
Code: 88VZV9HGT4
Classification: ACTIB
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT

Silk

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code36987-1120
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)

BOMBYX MORI FIBERActive
Quantity: 0.1 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
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT

Rabbit Epithelium

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code36987-1104
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: 0.1 g in 1 mL
Code: Z91WAU43WC
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

Mouse Epithelium

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code36987-1096
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: 0.1 g in 1 mL
Code: 390AN9GB09
Classification: ACTIB
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
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 Code36987-1112
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)

RATTUS NORVEGICUS SKINActive
Quantity: 0.1 g in 1 mL
Code: Y69HPD48AI
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

Hamster Epithelium

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code36987-1072
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: 0.1 g in 1 mL
Code: 3K873H631W
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

Cattle Epithelium

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code36987-1008
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)

BOS TAURUS SKINActive
Quantity: 0.1 g in 1 mL
Code: 7J12CD6O9L
Classification: ACTIB
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT

Goose Feathers

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code36987-1040
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: 0.1 g in 1 mL
Code: 15XI414745
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT

Dog Epithelium

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code36987-1016
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)

SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
CANIS LUPUS FAMILIARIS SKINActive
Quantity: 0.1 g in 1 mL
Code: X2W7CLE97T
Classification: ACTIB
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT

Hog Epithelium

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code36987-1080
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 BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
SUS SCROFA SKINActive
Quantity: 0.1 g in 1 mL
Code: 3EM4VW6TQN
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT

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Cattle Epithelium - FDA Drug Approval Details