Green Pea
Allergenic Extract
Approved
Approval ID
f2adabd1-ea12-437a-a902-da240cf2a62c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 17, 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.
Cucumber
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code49288-0118
Application NumberBLA102223
Product Classification
M
Marketing Category
C73585
G
Generic Name
Cucumber
Product Specifications
Route of AdministrationSUBCUTANEOUS, INTRADERMAL
Effective DateNovember 17, 2009
FDA Product Classification
INGREDIENTS (5)
SODIUM BICARBONATEInactive
Quantity: 0.0024 g in 1 mL
Code: 8MDF5V39QO
Classification: IACT
CUCUMBERActive
Quantity: 0.05 g in 1 mL
Code: YY7C30VXJT
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
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Pecan Nut Meat
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code49288-0383
Application NumberBLA102223
Product Classification
M
Marketing Category
C73585
G
Generic Name
Pecan Nut Meat
Product Specifications
Route of AdministrationINTRADERMAL, SUBCUTANEOUS
Effective DateNovember 17, 2009
FDA Product Classification
INGREDIENTS (5)
PECANActive
Quantity: 0.05 g in 1 mL
Code: F14P91GB5F
Classification: ACTIB
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
GLYCERINInactive
Quantity: 0.525 mL in 1 mL
Code: PDC6A3C0OX
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Coconut
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code49288-0120
Application NumberBLA102223
Product Classification
M
Marketing Category
C73585
G
Generic Name
Coconut
Product Specifications
Route of AdministrationSUBCUTANEOUS, INTRADERMAL
Effective DateNovember 17, 2009
FDA Product Classification
INGREDIENTS (5)
COCONUTActive
Quantity: 0.05 g in 1 mL
Code: 3RT3536DHY
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 Bean Cacao
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code49288-0115
Application NumberBLA102223
Product Classification
M
Marketing Category
C73585
G
Generic Name
Whole Bean Cacao
Product Specifications
Route of AdministrationSUBCUTANEOUS, INTRADERMAL
Effective DateNovember 17, 2009
FDA Product Classification
INGREDIENTS (5)
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
COCOA BEANActive
Quantity: 0.05 g in 1 mL
Code: D9108TZ9KG
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Date
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code49288-0161
Application NumberBLA102223
Product Classification
M
Marketing Category
C73585
G
Generic Name
Date
Product Specifications
Route of AdministrationSUBCUTANEOUS, INTRADERMAL
Effective DateNovember 17, 2009
FDA Product Classification
INGREDIENTS (5)
DATEActive
Quantity: 0.05 g in 1 mL
Code: H3O7QI5HY7
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
SODIUM CHLORIDEInactive
Quantity: 0.0095 g in 1 mL
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Caraway Seed
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code49288-0152
Application NumberBLA102223
Product Classification
M
Marketing Category
C73585
G
Generic Name
Caraway Seed
Product Specifications
Route of AdministrationSUBCUTANEOUS, INTRADERMAL
Effective DateNovember 17, 2009
FDA Product Classification
INGREDIENTS (5)
SODIUM CHLORIDEInactive
Quantity: 0.0095 g in 1 mL
Code: 451W47IQ8X
Classification: IACT
CARAWAYActive
Quantity: 0.05 g in 1 mL
Code: W2FH8O2BBE
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
Cumin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code49288-0155
Application NumberBLA102223
Product Classification
M
Marketing Category
C73585
G
Generic Name
Cumin
Product Specifications
Route of AdministrationSUBCUTANEOUS, INTRADERMAL
Effective DateNovember 17, 2009
FDA Product Classification
INGREDIENTS (5)
CUMINActive
Quantity: 0.05 g in 1 mL
Code: AG9BNA51DQ
Classification: ACTIB
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
GLYCERINInactive
Quantity: 0.525 mL in 1 mL
Code: PDC6A3C0OX
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Celery
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code49288-0108
Application NumberBLA102223
Product Classification
M
Marketing Category
C73585
G
Generic Name
Celery
Product Specifications
Route of AdministrationSUBCUTANEOUS, INTRADERMAL
Effective DateNovember 17, 2009
FDA Product Classification
INGREDIENTS (5)
SODIUM BICARBONATEInactive
Quantity: 0.0024 g in 1 mL
Code: 8MDF5V39QO
Classification: IACT
CELERYActive
Quantity: 0.05 g in 1 mL
Code: 44IDY6DTKX
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
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Cauliflower
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code49288-0107
Application NumberBLA102223
Product Classification
M
Marketing Category
C73585
G
Generic Name
Cauliflower
Product Specifications
Route of AdministrationSUBCUTANEOUS, INTRADERMAL
Effective DateNovember 17, 2009
FDA Product Classification
INGREDIENTS (5)
CAULIFLOWERActive
Quantity: 0.05 g in 1 mL
Code: 138LUT2DWV
Classification: ACTIB
GLYCERINInactive
Quantity: 0.525 mL in 1 mL
Code: PDC6A3C0OX
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
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
Cranberry
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code49288-0117
Application NumberBLA102223
Product Classification
M
Marketing Category
C73585
G
Generic Name
Cranberry
Product Specifications
Route of AdministrationSUBCUTANEOUS, INTRADERMAL
Effective DateNovember 17, 2009
FDA Product Classification
INGREDIENTS (5)
CRANBERRYActive
Quantity: 0.05 g in 1 mL
Code: 0MVO31Q3QS
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