MedPath

Cattle Epithelium

Allergenic Extract

Approved
Approval ID

1e43cb5e-cccc-4319-94a5-6c41bd9a3bc5

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 Code36987-1071
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: 0.1 g in 1 mL
Code: 3K873H631W
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
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 Code36987-1111
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: 0.1 g in 1 mL
Code: Y69HPD48AI
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT

Silk

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code36987-1119
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 (5)

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
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 Code36987-1103
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: 0.1 g in 1 mL
Code: Z91WAU43WC
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT

Mouse Epithelium

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code36987-1095
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 (5)

SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
MUS MUSCULUS SKINActive
Quantity: 0.1 g in 1 mL
Code: 390AN9GB09
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT

Hog Epithelium

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code36987-1079
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 (5)

SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
SUS SCROFA SKINActive
Quantity: 0.1 g in 1 mL
Code: 3EM4VW6TQN
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT

Horse Epithelium

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code36987-1087
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
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
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

Cattle Epithelium

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code36987-1007
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 (5)

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

Chicken Feathers

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code36987-1023
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)

GALLUS GALLUS FEATHERActive
Quantity: 0.1 g in 1 mL
Code: 1FCM16V0FV
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT

Dog Epithelium

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code36987-1015
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
CANIS LUPUS FAMILIARIS SKINActive
Quantity: 0.1 g in 1 mL
Code: X2W7CLE97T
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT

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Cattle Epithelium - FDA Drug Approval Details