Egg White
Allergenic Extract
Approved
Approval ID
b87af4d5-8677-413e-b0d5-91e2ca944460
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.
Chicken Meat
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code36987-1149
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 (6)
CHICKENActive
Quantity: 0.1 g in 1 mL
Code: 0X8Q245Y7B
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
Lamb
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code36987-1157
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 (6)
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
LAMBActive
Quantity: 0.1 g in 1 mL
Code: FOF26T73HA
Classification: ACTIB
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
Pork
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code36987-1165
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 (6)
PORKActive
Quantity: 0.1 g in 1 mL
Code: O138UB266J
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
Beef Liver
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code36987-1161
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 (6)
ALLERGENIC EXTRACT- BEEF LIVERActive
Quantity: 0.1 g in 1 mL
Code: W8N8R55022
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
Turkey
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code36987-1169
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 (6)
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
TURKEYActive
Quantity: 0.1 g in 1 mL
Code: 8E9NT44R8I
Classification: ACTIB
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Veal
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code36987-1173
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 (6)
VEALActive
Quantity: 0.1 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
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
Egg Yolk
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code36987-1137
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
Egg Yolk
Product Specifications
Route of AdministrationINTRADERMAL, SUBCUTANEOUS
Effective DateDecember 10, 2009
FDA Product Classification
INGREDIENTS (6)
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
EGG YOLKActive
Quantity: 0.1 g in 1 mL
Code: 4IPS17B70T
Classification: ACTIB
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
Beef
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code36987-1145
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 (6)
BEEFActive
Quantity: 0.1 g in 1 mL
Code: 4PIB2155QP
Classification: ACTIB
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
Egg White
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code36987-1133
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 (6)
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
EGG WHITEActive
Quantity: 0.1 g in 1 mL
Code: 3E0I92Z2GR
Classification: ACTIB
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
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 Code36987-1153
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 (6)
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
DUCKActive
Quantity: 0.1 g in 1 mL
Code: 28ON068RWM
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT