Cow Milk
Allergenic Extract
Approved
Approval ID
422e7c71-ab7d-4064-97b9-a2d0527f18b0
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 13, 2009
Manufacturers
FDA
Antigen Laboratories, Inc.
DUNS: 030705628
Products 10
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Lamb
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code49288-0287
Application NumberBLA102223
Product Classification
M
Marketing Category
C73585
G
Generic Name
Lamb
Product Specifications
Route of AdministrationSUBCUTANEOUS, INTRADERMAL
Effective DateNovember 13, 2009
FDA Product Classification
INGREDIENTS (5)
LAMBActive
Quantity: 0.05 g in 1 mL
Code: FOF26T73HA
Classification: ACTIB
GLYCERINInactive
Quantity: 0.525 mL in 1 mL
Code: PDC6A3C0OX
Classification: IACT
SODIUM BICARBONATEInactive
Quantity: 0.0024 g in 1 mL
Code: 8MDF5V39QO
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM CHLORIDEInactive
Quantity: 0.0095 g in 1 mL
Code: 451W47IQ8X
Classification: IACT
Venison
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code49288-0592
Application NumberBLA102223
Product Classification
M
Marketing Category
C73585
G
Generic Name
Venison
Product Specifications
Route of AdministrationSUBCUTANEOUS, INTRADERMAL
Effective DateNovember 13, 2009
FDA Product Classification
INGREDIENTS (5)
SODIUM BICARBONATEInactive
Quantity: 0.0024 g in 1 mL
Code: 8MDF5V39QO
Classification: IACT
VENISONActive
Quantity: 0.05 g in 1 mL
Code: 85EA9K88OY
Classification: ACTIB
GLYCERINInactive
Quantity: 0.525 mL in 1 mL
Code: PDC6A3C0OX
Classification: IACT
SODIUM CHLORIDEInactive
Quantity: 0.0095 g in 1 mL
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Goose Meat
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code49288-0220
Application NumberBLA102223
Product Classification
M
Marketing Category
C73585
G
Generic Name
Goose Meat
Product Specifications
Route of AdministrationSUBCUTANEOUS, INTRADERMAL
Effective DateNovember 13, 2009
FDA Product Classification
INGREDIENTS (5)
GOOSEActive
Quantity: 0.05 g in 1 mL
Code: 83DC4O5TD3
Classification: ACTIB
SODIUM CHLORIDEInactive
Quantity: 0.0095 g in 1 mL
Code: 451W47IQ8X
Classification: IACT
GLYCERINInactive
Quantity: 0.525 mL in 1 mL
Code: PDC6A3C0OX
Classification: IACT
SODIUM BICARBONATEInactive
Quantity: 0.0024 g in 1 mL
Code: 8MDF5V39QO
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Turkey
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code49288-0570
Application NumberBLA102223
Product Classification
M
Marketing Category
C73585
G
Generic Name
Turkey
Product Specifications
Route of AdministrationSUBCUTANEOUS, INTRADERMAL
Effective DateNovember 13, 2009
FDA Product Classification
INGREDIENTS (5)
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM BICARBONATEInactive
Quantity: 0.0024 g in 1 mL
Code: 8MDF5V39QO
Classification: IACT
TURKEYActive
Quantity: 0.05 g in 1 mL
Code: 8E9NT44R8I
Classification: ACTIB
GLYCERINInactive
Quantity: 0.525 mL in 1 mL
Code: PDC6A3C0OX
Classification: IACT
SODIUM CHLORIDEInactive
Quantity: 0.0095 g in 1 mL
Code: 451W47IQ8X
Classification: IACT
Beef
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code49288-0070
Application NumberBLA102223
Product Classification
M
Marketing Category
C73585
G
Generic Name
Beef
Product Specifications
Route of AdministrationSUBCUTANEOUS, INTRADERMAL
Effective DateNovember 13, 2009
FDA Product Classification
INGREDIENTS (5)
BEEFActive
Quantity: 0.05 g in 1 mL
Code: 4PIB2155QP
Classification: ACTIB
GLYCERINInactive
Quantity: 0.525 mL in 1 mL
Code: PDC6A3C0OX
Classification: IACT
SODIUM CHLORIDEInactive
Quantity: 0.0095 g in 1 mL
Code: 451W47IQ8X
Classification: IACT
SODIUM BICARBONATEInactive
Quantity: 0.0024 g in 1 mL
Code: 8MDF5V39QO
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Chicken
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code49288-0113
Application NumberBLA102223
Product Classification
M
Marketing Category
C73585
G
Generic Name
Chicken
Product Specifications
Route of AdministrationSUBCUTANEOUS, INTRADERMAL
Effective DateNovember 13, 2009
FDA Product Classification
INGREDIENTS (5)
SODIUM BICARBONATEInactive
Quantity: 0.0024 g in 1 mL
Code: 8MDF5V39QO
Classification: IACT
CHICKENActive
Quantity: 0.05 g in 1 mL
Code: 0X8Q245Y7B
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
GLYCERINInactive
Quantity: 0.525 mL in 1 mL
Code: PDC6A3C0OX
Classification: IACT
SODIUM CHLORIDEInactive
Quantity: 0.0095 g in 1 mL
Code: 451W47IQ8X
Classification: IACT
Pork
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code49288-0375
Application NumberBLA102223
Product Classification
M
Marketing Category
C73585
G
Generic Name
Pork
Product Specifications
Route of AdministrationSUBCUTANEOUS, INTRADERMAL
Effective DateNovember 13, 2009
FDA Product Classification
INGREDIENTS (5)
PORKActive
Quantity: 0.05 g in 1 mL
Code: O138UB266J
Classification: ACTIB
SODIUM BICARBONATEInactive
Quantity: 0.0024 g in 1 mL
Code: 8MDF5V39QO
Classification: IACT
SODIUM CHLORIDEInactive
Quantity: 0.0095 g in 1 mL
Code: 451W47IQ8X
Classification: IACT
GLYCERINInactive
Quantity: 0.525 mL in 1 mL
Code: PDC6A3C0OX
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Egg White
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code49288-0188
Application NumberBLA102223
Product Classification
M
Marketing Category
C73585
G
Generic Name
Egg White
Product Specifications
Route of AdministrationSUBCUTANEOUS, INTRADERMAL
Effective DateNovember 13, 2009
FDA Product Classification
INGREDIENTS (5)
EGG WHITEActive
Quantity: 0.05 g in 1 mL
Code: 3E0I92Z2GR
Classification: ACTIB
GLYCERINInactive
Quantity: 0.525 mL in 1 mL
Code: PDC6A3C0OX
Classification: IACT
SODIUM CHLORIDEInactive
Quantity: 0.0095 g in 1 mL
Code: 451W47IQ8X
Classification: IACT
SODIUM BICARBONATEInactive
Quantity: 0.0024 g in 1 mL
Code: 8MDF5V39QO
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Whole Egg
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code49288-0189
Application NumberBLA102223
Product Classification
M
Marketing Category
C73585
G
Generic Name
Whole Egg
Product Specifications
Route of AdministrationSUBCUTANEOUS, INTRADERMAL
Effective DateNovember 13, 2009
FDA Product Classification
INGREDIENTS (5)
EGGActive
Quantity: 0.05 g in 1 mL
Code: 291P45F896
Classification: ACTIB
GLYCERINInactive
Quantity: 0.525 mL in 1 mL
Code: PDC6A3C0OX
Classification: IACT
SODIUM CHLORIDEInactive
Quantity: 0.0095 g in 1 mL
Code: 451W47IQ8X
Classification: IACT
SODIUM BICARBONATEInactive
Quantity: 0.0024 g in 1 mL
Code: 8MDF5V39QO
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Cow Milk
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code49288-0301
Application NumberBLA102223
Product Classification
M
Marketing Category
C73585
G
Generic Name
Cow Milk
Product Specifications
Route of AdministrationSUBCUTANEOUS, INTRADERMAL
Effective DateNovember 13, 2009
FDA Product Classification
INGREDIENTS (5)
COW MILKActive
Quantity: 0.05 g in 1 mL
Code: 917J3173FT
Classification: ACTIB
GLYCERINInactive
Quantity: 0.525 mL in 1 mL
Code: PDC6A3C0OX
Classification: IACT
SODIUM CHLORIDEInactive
Quantity: 0.0095 g in 1 mL
Code: 451W47IQ8X
Classification: IACT
SODIUM BICARBONATEInactive
Quantity: 0.0024 g in 1 mL
Code: 8MDF5V39QO
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT