Western Water Hemp
Allergenic Extract
Approved
Approval ID
b8e9933d-eeb3-4379-aaa4-5dfb1179683f
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.
Jerusalem Oak
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code49288-0628
Application NumberBLA102223
Product Classification
M
Marketing Category
C73585
G
Generic Name
Jerusalem Oak
Product Specifications
Route of AdministrationSUBCUTANEOUS, INTRADERMAL
Effective DateNovember 13, 2009
FDA Product Classification
INGREDIENTS (5)
CHENOPODIUM BOTRYS POLLENActive
Quantity: 0.05 g in 1 mL
Code: IVU789297D
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
Sorrel Mixture
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code49288-0460
Application NumberBLA102223
Product Classification
M
Marketing Category
C73585
G
Generic Name
Sorrel Mixture
Product Specifications
Route of AdministrationSUBCUTANEOUS, INTRADERMAL
Effective DateNovember 13, 2009
FDA Product Classification
INGREDIENTS (9)
RUMEX ACETOSELLA POLLENActive
Quantity: 0.004 g in 1 mL
Code: N52MIQ81ZW
Classification: ACTIB
RUMEX OBTUSIFOLIUS POLLENActive
Quantity: 0.004 g in 1 mL
Code: R6H8O3GVL9
Classification: ACTIB
RUMEX SALICIFOLIUS VAR. MEXICANUS POLLENActive
Quantity: 0.004 g in 1 mL
Code: BHS470V9ON
Classification: ACTIB
RUMEX CRISPUS POLLENActive
Quantity: 0.004 g in 1 mL
Code: V825XJG64G
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
RUMEX ALTISSIMUS POLLENActive
Quantity: 0.004 g in 1 mL
Code: BML0J15H8W
Classification: ACTIB
SODIUM BICARBONATEInactive
Quantity: 0.0024 g in 1 mL
Code: 8MDF5V39QO
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Rough (Redroot) Pigweed
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code49288-0409
Application NumberBLA102223
Product Classification
M
Marketing Category
C73585
G
Generic Name
Rough (Redroot) Pigweed
Product Specifications
Route of AdministrationSUBCUTANEOUS, INTRADERMAL
Effective DateNovember 13, 2009
FDA Product Classification
INGREDIENTS (5)
AMARANTHUS RETROFLEXUS POLLENActive
Quantity: 0.05 g in 1 mL
Code: 73B14PX5FW
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
SODIUM BICARBONATEInactive
Quantity: 0.0024 g in 1 mL
Code: 8MDF5V39QO
Classification: IACT
Marsh Elder Mixture
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code49288-0268
Application NumberBLA102223
Product Classification
M
Marketing Category
C73585
G
Generic Name
Marsh Elder Mixture
Product Specifications
Route of AdministrationSUBCUTANEOUS, INTRADERMAL
Effective DateNovember 13, 2009
FDA Product Classification
INGREDIENTS (6)
GLYCERINInactive
Quantity: 0.525 mL in 1 mL
Code: PDC6A3C0OX
Classification: IACT
IVA XANTHIFOLIA POLLENActive
Quantity: 0.01 g in 1 mL
Code: V80TPZ0T6J
Classification: ACTIB
SODIUM CHLORIDEInactive
Quantity: 0.0095 g in 1 mL
Code: 451W47IQ8X
Classification: IACT
IVA ANNUA VAR. ANNUA POLLENActive
Quantity: 0.01 g in 1 mL
Code: Y2U5S5PF22
Classification: ACTIB
SODIUM BICARBONATEInactive
Quantity: 0.0024 g in 1 mL
Code: 8MDF5V39QO
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
English Plantain
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code49288-0361
Application NumberBLA102223
Product Classification
M
Marketing Category
C73585
G
Generic Name
English Plantain
Product Specifications
Route of AdministrationSUBCUTANEOUS, INTRADERMAL
Effective DateNovember 13, 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
PLANTAGO LANCEOLATA POLLENActive
Quantity: 0.05 g in 1 mL
Code: DO87T1U2CI
Classification: ACTIB
SODIUM BICARBONATEInactive
Quantity: 0.0024 g in 1 mL
Code: 8MDF5V39QO
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Russian Thistle
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code49288-0433
Application NumberBLA102223
Product Classification
M
Marketing Category
C73585
G
Generic Name
Russian Thistle
Product Specifications
Route of AdministrationSUBCUTANEOUS, INTRADERMAL
Effective DateNovember 13, 2009
FDA Product Classification
INGREDIENTS (5)
SODIUM CHLORIDEInactive
Quantity: 0.0095 g in 1 mL
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM BICARBONATEInactive
Quantity: 0.0024 g in 1 mL
Code: 8MDF5V39QO
Classification: IACT
SALSOLA KALI POLLENActive
Quantity: 0.05 g in 1 mL
Code: 2MH135KC6G
Classification: ACTIB
GLYCERINInactive
Quantity: 0.525 mL in 1 mL
Code: PDC6A3C0OX
Classification: IACT
English Plantain
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code49288-0362
Application NumberBLA102223
Product Classification
M
Marketing Category
C73585
G
Generic Name
English Plantain
Product Specifications
Route of AdministrationSUBCUTANEOUS, INTRADERMAL
Effective DateNovember 13, 2009
FDA Product Classification
INGREDIENTS (5)
GLYCERINInactive
Quantity: 0.525 mL in 1 mL
Code: PDC6A3C0OX
Classification: IACT
PLANTAGO LANCEOLATA POLLENActive
Quantity: 0.02 g in 1 mL
Code: DO87T1U2CI
Classification: ACTIB
SODIUM CHLORIDEInactive
Quantity: 0.0095 g in 1 mL
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM BICARBONATEInactive
Quantity: 0.0024 g in 1 mL
Code: 8MDF5V39QO
Classification: IACT
Kochia
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code49288-0284
Application NumberBLA102223
Product Classification
M
Marketing Category
C73585
G
Generic Name
Kochia
Product Specifications
Route of AdministrationSUBCUTANEOUS, INTRADERMAL
Effective DateNovember 13, 2009
FDA Product Classification
INGREDIENTS (5)
KOCHIA SCOPARIA POLLENActive
Quantity: 0.02 g in 1 mL
Code: 07A108ZKW5
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
SODIUM BICARBONATEInactive
Quantity: 0.0024 g in 1 mL
Code: 8MDF5V39QO
Classification: IACT
Chenopodium Mixture
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code49288-0086
Application NumberBLA102223
Product Classification
M
Marketing Category
C73585
G
Generic Name
Chenopodium Mixture
Product Specifications
Route of AdministrationSUBCUTANEOUS, INTRADERMAL
Effective DateNovember 13, 2009
FDA Product Classification
INGREDIENTS (7)
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM BICARBONATEInactive
Quantity: 0.0024 g in 1 mL
Code: 8MDF5V39QO
Classification: IACT
CHENOPODIUM BOTRYS POLLENActive
Quantity: 0.0067 g in 1 mL
Code: IVU789297D
Classification: ACTIB
CHENOPODIUM ALBUM POLLENActive
Quantity: 0.0067 g in 1 mL
Code: 098LKX5NCN
Classification: ACTIB
CHENOPODIUM AMBROSIOIDES POLLENActive
Quantity: 0.0067 g in 1 mL
Code: WIB701MW2H
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
Desert Sage
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code49288-0497
Application NumberBLA102223
Product Classification
M
Marketing Category
C73585
G
Generic Name
Desert Sage
Product Specifications
Route of AdministrationSUBCUTANEOUS, INTRADERMAL
Effective DateNovember 13, 2009
FDA Product Classification
INGREDIENTS (5)
GLYCERINInactive
Quantity: 0.525 mL in 1 mL
Code: PDC6A3C0OX
Classification: IACT
ARTEMISIA TRIDENTATA POLLENActive
Quantity: 0.05 g in 1 mL
Code: YI19RB8YFD
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
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