Flaxseed
Allergenic Extract “For Diagnostic Use Only”
Approved
Approval ID
040dacaf-4ccf-425a-9b40-586176b7631d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 12, 2009
Manufacturers
FDA
Antigen Laboratories, Inc.
DUNS: 030705628
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Cottonseed
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code49288-0116
Application NumberBLA102223
Product Classification
M
Marketing Category
C73585
G
Generic Name
Cottonseed
Product Specifications
Route of AdministrationINTRADERMAL, SUBCUTANEOUS
Effective DateNovember 12, 2009
FDA Product Classification
INGREDIENTS (5)
COTTON SEEDActive
Quantity: 0.05 g in 1 mL
Code: DI0ZRJ0MXN
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
Coffee
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code49288-0100
Application NumberBLA102223
Product Classification
M
Marketing Category
C73585
G
Generic Name
Coffee
Product Specifications
Route of AdministrationINTRADERMAL, SUBCUTANEOUS
Effective DateNovember 12, 2009
FDA Product Classification
INGREDIENTS (5)
ARABICA COFFEE BEANActive
Quantity: 0.05 g in 1 mL
Code: 3SW678MX72
Classification: ACTIB
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
SODIUM CHLORIDEInactive
Quantity: 0.0095 g in 1 mL
Code: 451W47IQ8X
Classification: IACT
Flaxseed
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code49288-0201
Application NumberBLA102223
Product Classification
M
Marketing Category
C73585
G
Generic Name
Flaxseed
Product Specifications
Route of AdministrationINTRADERMAL, SUBCUTANEOUS
Effective DateNovember 12, 2009
FDA Product Classification
INGREDIENTS (5)
FLAX SEEDActive
Quantity: 0.05 g in 1 mL
Code: 4110YT348C
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