Western Black Willow
Allergenic Extract
Approved
Approval ID
3be2afc4-b2dc-4b0f-b314-5ade25922b66
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 19, 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.
Box Elder
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code49288-0059
Application NumberBLA102223
Product Classification
M
Marketing Category
C73585
G
Generic Name
Box Elder
Product Specifications
Route of AdministrationSUBCUTANEOUS, INTRADERMAL
Effective DateNovember 19, 2009
FDA Product Classification
INGREDIENTS (5)
GLYCERINInactive
Quantity: 0.525 mL in 1 mL
Code: PDC6A3C0OX
Classification: IACT
ACER NEGUNDO POLLENActive
Quantity: 0.1 g in 1 mL
Code: P6K070AR8V
Classification: ACTIB
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
Smooth (Tag) Alder
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code49288-0015
Application NumberBLA102223
Product Classification
M
Marketing Category
C73585
G
Generic Name
Smooth (Tag) Alder
Product Specifications
Route of AdministrationSUBCUTANEOUS, INTRADERMAL
Effective DateNovember 19, 2009
FDA Product Classification
INGREDIENTS (5)
ALNUS INCANA SUBSP. RUGOSA POLLENActive
Quantity: 0.05 g in 1 mL
Code: 605T96G8Y5
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
Spring (Water) Birch
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code49288-0058
Application NumberBLA102223
Product Classification
M
Marketing Category
C73585
G
Generic Name
Spring (Water) Birch
Product Specifications
Route of AdministrationSUBCUTANEOUS, INTRADERMAL
Effective DateNovember 19, 2009
FDA Product Classification
INGREDIENTS (5)
GLYCERINInactive
Quantity: 0.525 mL in 1 mL
Code: PDC6A3C0OX
Classification: IACT
BETULA OCCIDENTALIS POLLENActive
Quantity: 0.05 g in 1 mL
Code: R889N2L976
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
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Acacia Pollen
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code49288-0014
Application NumberBLA102223
Product Classification
M
Marketing Category
C73585
G
Generic Name
Acacia Pollen
Product Specifications
Route of AdministrationSUBCUTANEOUS, INTRADERMAL
Effective DateNovember 19, 2009
FDA Product Classification
INGREDIENTS (5)
GLYCERINInactive
Quantity: 0.525 mL in 1 mL
Code: PDC6A3C0OX
Classification: IACT
ACACIA BAILEYANA POLLENActive
Quantity: 0.05 g in 1 mL
Code: 59WAV8G5X5
Classification: ACTIB
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
Melaleuca
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code49288-0317
Application NumberBLA102223
Product Classification
M
Marketing Category
C73585
G
Generic Name
Melaleuca
Product Specifications
Route of AdministrationSUBCUTANEOUS, INTRADERMAL
Effective DateNovember 19, 2009
FDA Product Classification
INGREDIENTS (5)
MELALEUCA QUINQUENERVIA POLLENActive
Quantity: 0.05 g in 1 mL
Code: NX974IRT8E
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
Hard (Sugar) Maple
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code49288-0321
Application NumberBLA102223
Product Classification
M
Marketing Category
C73585
G
Generic Name
Hard (Sugar) Maple
Product Specifications
Route of AdministrationSUBCUTANEOUS, INTRADERMAL
Effective DateNovember 19, 2009
FDA Product Classification
INGREDIENTS (5)
GLYCERINInactive
Quantity: 0.525 mL in 1 mL
Code: PDC6A3C0OX
Classification: IACT
ACER SACCHARUM POLLENActive
Quantity: 0.05 g in 1 mL
Code: V38QUQ7861
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
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Soft (Silver) Maple
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code49288-0323
Application NumberBLA102223
Product Classification
M
Marketing Category
C73585
G
Generic Name
Soft (Silver) Maple
Product Specifications
Route of AdministrationSUBCUTANEOUS, INTRADERMAL
Effective DateNovember 19, 2009
FDA Product Classification
INGREDIENTS (5)
ACER SACCHARINUM POLLENActive
Quantity: 0.05 g in 1 mL
Code: 95447163DG
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
SODIUM BICARBONATEInactive
Quantity: 0.0024 g in 1 mL
Code: 8MDF5V39QO
Classification: IACT
Utah Juniper
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code49288-0274
Application NumberBLA102223
Product Classification
M
Marketing Category
C73585
G
Generic Name
Utah Juniper
Product Specifications
Route of AdministrationSUBCUTANEOUS, INTRADERMAL
Effective DateNovember 19, 2009
FDA Product Classification
INGREDIENTS (5)
JUNIPERUS OSTEOSPERMA POLLENActive
Quantity: 0.05 g in 1 mL
Code: 15L060HV8H
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
California (Coastal) Live Oak
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code49288-0337
Application NumberBLA102223
Product Classification
M
Marketing Category
C73585
G
Generic Name
California (Coastal) Live Oak
Product Specifications
Route of AdministrationSUBCUTANEOUS, INTRADERMAL
Effective DateNovember 19, 2009
FDA Product Classification
INGREDIENTS (5)
SODIUM BICARBONATEInactive
Quantity: 0.0024 g in 1 mL
Code: 8MDF5V39QO
Classification: IACT
QUERCUS AGRIFOLIA POLLENActive
Quantity: 0.05 g in 1 mL
Code: VOT5MA71M7
Classification: ACTIB
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
Red Maple
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code49288-0322
Application NumberBLA102223
Product Classification
M
Marketing Category
C73585
G
Generic Name
Red Maple
Product Specifications
Route of AdministrationSUBCUTANEOUS, INTRADERMAL
Effective DateNovember 19, 2009
FDA Product Classification
INGREDIENTS (5)
ACER RUBRUM POLLENActive
Quantity: 0.05 g in 1 mL
Code: 700NK45C76
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
SODIUM CHLORIDEInactive
Quantity: 0.0095 g in 1 mL
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT