Egg White
Allergenic Extract
Approved
Approval ID
5a796ac4-8adc-4d01-84d7-30219f61fe33
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 10, 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.
Beef Liver
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code36987-1158
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
Beef Liver
Product Specifications
Route of AdministrationINTRADERMAL, SUBCUTANEOUS
Effective DateDecember 10, 2009
FDA Product Classification
INGREDIENTS (5)
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
ALLERGENIC EXTRACT- BEEF LIVERActive
Quantity: 0.05 g in 1 mL
Code: W8N8R55022
Classification: ACTIB
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Beef
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code36987-1142
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
Beef
Product Specifications
Route of AdministrationINTRADERMAL, SUBCUTANEOUS
Effective DateDecember 10, 2009
FDA Product Classification
INGREDIENTS (5)
BEEFActive
Quantity: 0.05 g in 1 mL
Code: 4PIB2155QP
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Turkey
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code36987-1166
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
Turkey
Product Specifications
Route of AdministrationINTRADERMAL, SUBCUTANEOUS
Effective DateDecember 10, 2009
FDA Product Classification
INGREDIENTS (5)
TURKEYActive
Quantity: 0.05 g in 1 mL
Code: 8E9NT44R8I
Classification: ACTIB
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Pork
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code36987-1162
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
Pork
Product Specifications
Route of AdministrationINTRADERMAL, SUBCUTANEOUS
Effective DateDecember 10, 2009
FDA Product Classification
INGREDIENTS (5)
PORKActive
Quantity: 0.05 g in 1 mL
Code: O138UB266J
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Duck Meat
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code36987-1150
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
Duck Meat
Product Specifications
Route of AdministrationINTRADERMAL, SUBCUTANEOUS
Effective DateDecember 10, 2009
FDA Product Classification
INGREDIENTS (5)
DUCKActive
Quantity: 0.05 g in 1 mL
Code: 28ON068RWM
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Veal
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code36987-1170
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
Veal
Product Specifications
Route of AdministrationINTRADERMAL, SUBCUTANEOUS
Effective DateDecember 10, 2009
FDA Product Classification
INGREDIENTS (5)
VEALActive
Quantity: 0.05 g in 1 mL
Code: 0X5GW3050M
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 Meat
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code36987-1146
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
Chicken Meat
Product Specifications
Route of AdministrationINTRADERMAL, SUBCUTANEOUS
Effective DateDecember 10, 2009
FDA Product Classification
INGREDIENTS (5)
CHICKENActive
Quantity: 0.05 g in 1 mL
Code: 0X8Q245Y7B
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Egg White
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code36987-1130
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
Egg White
Product Specifications
Route of AdministrationINTRADERMAL, SUBCUTANEOUS
Effective DateDecember 10, 2009
FDA Product Classification
INGREDIENTS (5)
EGG WHITEActive
Quantity: 0.05 g in 1 mL
Code: 3E0I92Z2GR
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Whole Egg
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code36987-1138
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
Whole Egg
Product Specifications
Route of AdministrationINTRADERMAL, SUBCUTANEOUS
Effective DateDecember 10, 2009
FDA Product Classification
INGREDIENTS (5)
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
EGGActive
Quantity: 0.05 g in 1 mL
Code: 291P45F896
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Lamb
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code36987-1154
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
Lamb
Product Specifications
Route of AdministrationINTRADERMAL, SUBCUTANEOUS
Effective DateDecember 10, 2009
FDA Product Classification
INGREDIENTS (5)
LAMBActive
Quantity: 0.05 g in 1 mL
Code: FOF26T73HA
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT