Treatment Set TS332256

Registrants (1)

Antigen Laboratories, Inc.

DUNS Number

030705628

Manufacturing Establishments (1)

Antigen Laboratories, Inc.

Labeler

Antigen Laboratories, Inc.

Registrant

Antigen Laboratories, Inc.

DUNS Number

030705628

Products (59)

Treatment Set TS331795

NDC Product Code

49288-0769

Application Number

BLA102223

Marketing Category

BLA (C73585)

Route of Administration

SUBCUTANEOUS, INTRADERMAL

Effective Date

December 2, 2009

Ingredients

Ustilago cynodontisActive

Code: 0V3J4YEX2WClass: ACTIBQuantity: 0.001 g in 1 mL

Sporisorium cruentumActive

Code: GQM6LVU5V8Class: ACTIBQuantity: 0.001 g in 1 mL

Ustilago maydisActive

Code: 4K7Z7K7SWGClass: ACTIBQuantity: 0.0005 g in 1 mL

Ustilago avenaeActive

Code: YIH315U1TUClass: ACTIBQuantity: 0.0005 g in 1 mL

Ustilago nuda hordeiActive

Code: 9Y53ZS6I82Class: ACTIBQuantity: 0.0005 g in 1 mL

Ustilago triticiActive

Code: BV82OL2IZ8Class: ACTIBQuantity: 0.0005 g in 1 mL

Gallus gallus featherActive

Code: 1FCM16V0FVClass: ACTIBQuantity: 0.00067 g in 1 mL

Pleospora herbarumActive

Code: 0N3Z1P4B2WClass: ACTIBQuantity: 0.002 g in 1 mL

Anas platyrhynchos featherActive

Code: 83B65P4796Class: ACTIBQuantity: 0.00067 g in 1 mL

Anser anser featherActive

Code: 15XI414745Class: ACTIBQuantity: 0.00067 g in 1 mL

Penicillium chrysogenum var. chrysogenumActive

Code: 3Y1PE1GCIGClass: ACTIBQuantity: 0.002 g in 1 mL

Aureobasidium pullulans var. pullutansActive

Code: D1A2NG69CKClass: ACTIBQuantity: 0.002 g in 1 mL

Cochliobolus sativusActive

Code: 3LN5B70U4WClass: ACTIBQuantity: 0.002 g in 1 mL

Cladosporium cladosporioidesActive

Code: 4ZWY20GTGOClass: ACTIBQuantity: 0.002 g in 1 mL

Rhizopus stoloniferActive

Code: FEE198DK4QClass: ACTIBQuantity: 0.002 g in 1 mL

Dermatophagoides farinaeActive

Code: PR9U2YPF3QClass: ACTIBQuantity: 400 [AU] in 1 mL

Dermatophagoides pteronyssinusActive

Code: 57L1Z5378KClass: ACTIBQuantity: 16 [AU] in 1 mL

Phoma destructivaActive

Code: A17SE577FMClass: ACTIBQuantity: 0.002 g in 1 mL

PHENOLInactive

Code: 339NCG44TVClass: IACT

Periplaneta americanaActive

Code: 2RQ1L9N089Class: ACTIBQuantity: 0.002 g in 1 mL

Candida albicansActive

Code: 4D7G21HDBCClass: ACTIBQuantity: 0.002 g in 1 mL

WATERInactive

Code: 059QF0KO0RClass: IACT

Fusarium oxysporumActive

Code: 5398RXP8KUClass: ACTIBQuantity: 0.002 g in 1 mL

GLYCERINInactive

Code: PDC6A3C0OXClass: IACT

SODIUM BICARBONATEInactive

Code: 8MDF5V39QOClass: IACT

SODIUM CHLORIDEInactive

Code: 451W47IQ8XClass: IACT

Aspergillus fumigatusActive

Code: X88DF51T48Class: ACTIBQuantity: 0.002 g in 1 mL

Treatment Set TS334696

NDC Product Code

49288-0773

Application Number

BLA102223

Marketing Category

BLA (C73585)

Route of Administration

SUBCUTANEOUS, INTRADERMAL

Effective Date

December 2, 2009

Ingredients

Rumex acetosella pollenActive

Code: N52MIQ81ZWClass: ACTIBQuantity: 0.0000666 g in 1 mL

Urtica dioica pollenActive

Code: DNB59M1NVUClass: ACTIBQuantity: 0.0003333 g in 1 mL

Acer negundo pollenActive

Code: P6K070AR8VClass: ACTIBQuantity: 0.0000666 g in 1 mL

Canis lupus familiaris hairActive

Code: 05S7L91ZTRClass: ACTIBQuantity: 0.0008333 g in 1 mL

Juglans nigra pollenActive

Code: 1BV28146ZRClass: ACTIBQuantity: 0.0000666 g in 1 mL

Platanus occidentalis pollenActive

Code: E03U1K03LKClass: ACTIBQuantity: 0.0000666 g in 1 mL

Felis catus hairActive

Code: 1564HD0N96Class: ACTIBQuantity: 33.33 g in 1 mL

Juniperus ashei pollenActive

Code: 544F8MEY0YClass: ACTIBQuantity: 0.0000666 g in 1 mL

Populus deltoides pollenActive

Code: 476DVV63WPClass: ACTIBQuantity: 0.0000666 g in 1 mL

Fraxinus americana pollenActive

Code: G684LX721QClass: ACTIBQuantity: 0.0000133 g in 1 mL

Quercus alba pollenActive

Code: Z4Y9ZSV4KKClass: ACTIBQuantity: 0.0000666 g in 1 mL

Ulmus americana pollenActive

Code: 89BAT511BDClass: ACTIBQuantity: 0.0000666 g in 1 mL

Morus alba pollenActive

Code: 3I9T68187HClass: ACTIBQuantity: 0.00833 g in 1 mL

Cynodon dactylon pollenActive

Code: 175F461W10Class: ACTIBQuantity: 13.3333 g in 1 mL

Ambrosia artemisiifolia pollenActive

Code: K20Y81ACO3Class: ACTIBQuantity: 5.33 g in 1 mL

Phleum pratense pollenActive

Code: 65M88RW2EGClass: ACTIBQuantity: 666.67 g in 1 mL

Salsola kali pollenActive

Code: 2MH135KC6GClass: ACTIBQuantity: 0.0000666 g in 1 mL

Amaranthus retroflexus pollenActive

Code: 73B14PX5FWClass: ACTIBQuantity: 0.00033 g in 1 mL

Iva annua pollenActive

Code: Y2U5S5PF22Class: ACTIBQuantity: 0.0000666 g in 1 mL

Carya tomentosa pollenActive

Code: G2A764T54BClass: ACTIBQuantity: 0.0000333 g in 1 mL

Pecan pollenActive

Code: PYO4JR720YClass: ACTIBQuantity: 0.0000333 g in 1 mL

WATERInactive

Code: 059QF0KO0RClass: IACT

SODIUM CHLORIDEInactive

Code: 451W47IQ8XClass: IACT

SODIUM BICARBONATEInactive

Code: 8MDF5V39QOClass: IACT

GLYCERINInactive

Code: PDC6A3C0OXClass: IACT

Treatment Set TS331796

NDC Product Code

49288-0770

Application Number

BLA102223

Marketing Category

BLA (C73585)

Route of Administration

SUBCUTANEOUS, INTRADERMAL

Effective Date

December 2, 2009

Ingredients

Juniperus virginiana pollenActive

Code: PY0JA16R2GClass: ACTIBQuantity: 0.002 g in 1 mL

Carya tomentosa pollenActive

Code: G2A764T54BClass: ACTIBQuantity: 0.001 g in 1 mL

Pecan pollenActive

Code: PYO4JR720YClass: ACTIBQuantity: 0.001 g in 1 mL

Quercus alba pollenActive

Code: Z4Y9ZSV4KKClass: ACTIBQuantity: 0.002 g in 1 mL

Fraxinus americana pollenActive

Code: G684LX721QClass: ACTIBQuantity: 0.002 g in 1 mL

Cynodon dactylon pollenActive

Code: 175F461W10Class: ACTIBQuantity: 400 [BAU] in 1 mL

Populus deltoides pollenActive

Code: 476DVV63WPClass: ACTIBQuantity: 0.002 g in 1 mL

Acer negundo pollenActive

Code: P6K070AR8VClass: ACTIBQuantity: 0.002 g in 1 mL

Salsola kali pollenActive

Code: 2MH135KC6GClass: ACTIBQuantity: 0.002 g in 1 mL

Betula nigra pollenActive

Code: 93963RFO1PClass: ACTIBQuantity: 0.002 g in 1 mL

Chenopodium album pollenActive

Code: 098LKX5NCNClass: ACTIBQuantity: 0.002 g in 1 mL

Iva annua pollenActive

Code: Y2U5S5PF22Class: ACTIBQuantity: 0.0004 g in 1 mL

Amaranthus retroflexus pollenActive

Code: 73B14PX5FWClass: ACTIBQuantity: 0.00008 g in 1 mL

Rumex acetosella pollenActive

Code: N52MIQ81ZWClass: ACTIBQuantity: 0.002 g in 1 mL

WATERInactive

Code: 059QF0KO0RClass: IACT

PHENOLInactive

Code: 339NCG44TVClass: IACT

SODIUM BICARBONATEInactive

Code: 8MDF5V39QOClass: IACT

GLYCERINInactive

Code: PDC6A3C0OXClass: IACT

SODIUM CHLORIDEInactive

Code: 451W47IQ8XClass: IACT

Treatment Set TS332679

NDC Product Code

49288-0768

Application Number

BLA102223

Marketing Category

BLA (C73585)

Route of Administration

SUBCUTANEOUS, INTRADERMAL

Effective Date

December 2, 2009

Ingredients

Ambrosia trifida pollenActive

Code: KU1V1898XXClass: ACTIBQuantity: 0.0000267 g in 1 mL

Carya tomentosa pollenActive

Code: G2A764T54BClass: ACTIBQuantity: 0.00004 g in 1 mL

Ambrosia artemisiifolia pollenActive

Code: K20Y81ACO3Class: ACTIBQuantity: 0.0000267 g in 1 mL

Ambrosia psilostachya pollenActive

Code: RX18M46K8LClass: ACTIBQuantity: 0.0000267 g in 1 mL

Pecan pollenActive

Code: PYO4JR720YClass: ACTIBQuantity: 0.00004 g in 1 mL

Quercus alba pollenActive

Code: Z4Y9ZSV4KKClass: ACTIBQuantity: 0.00008 g in 1 mL

Fraxinus americana pollenActive

Code: G684LX721QClass: ACTIBQuantity: 0.00008 g in 1 mL

Juniperus virginiana pollenActive

Code: PY0JA16R2GClass: ACTIBQuantity: 0.00008 g in 1 mL

Acer negundo pollenActive

Code: P6K070AR8VClass: ACTIBQuantity: 0.00008 g in 1 mL

Populus deltoides pollenActive

Code: 476DVV63WPClass: ACTIBQuantity: 0.00008 g in 1 mL

Cynodon dactylon pollenActive

Code: 175F461W10Class: ACTIBQuantity: 16 [BAU] in 1 mL

Ulmus americana pollenActive

Code: 89BAT511BDClass: ACTIBQuantity: 0.00008 g in 1 mL

Poa pratensis pollenActive

Code: SCB8J7LS3TClass: ACTIBQuantity: 160 [BAU] in 1 mL

Plantago lanceolata pollenActive

Code: DO87T1U2CIClass: ACTIBQuantity: 0.00008 g in 1 mL

Rumex acetosella pollenActive

Code: N52MIQ81ZWClass: ACTIBQuantity: 0.002 g in 1 mL

Chenopodium album pollenActive

Code: 098LKX5NCNClass: ACTIBQuantity: 0.002 g in 1 mL

Sorghum halepense pollenActive

Code: 577VA5B4HPClass: ACTIBQuantity: 0.0004 g in 1 mL

Bassia scoparia pollenActive

Code: 07A108ZKW5Class: ACTIBQuantity: 0.002 g in 1 mL

Betula nigra pollenActive

Code: 93963RFO1PClass: ACTIBQuantity: 0.00008 g in 1 mL

Salsola kali pollenActive

Code: 2MH135KC6GClass: ACTIBQuantity: 0.002 g in 1 mL

WATERInactive

Code: 059QF0KO0RClass: IACT

GLYCERINInactive

Code: PDC6A3C0OXClass: IACT

SODIUM CHLORIDEInactive

Code: 451W47IQ8XClass: IACT

PHENOLInactive

Code: 339NCG44TVClass: IACT

SODIUM BICARBONATEInactive

Code: 8MDF5V39QOClass: IACT

Amaranthus retroflexus pollenActive

Code: 73B14PX5FWClass: ACTIBQuantity: 0.0004 g in 1 mL

Iva annua pollenActive

Code: Y2U5S5PF22Class: ACTIBQuantity: 0.0004 g in 1 mL

Treatment Set TS329413

NDC Product Code

49288-0771

Application Number

BLA102223

Marketing Category

BLA (C73585)

Route of Administration

SUBCUTANEOUS, INTRADERMAL

Effective Date

December 2, 2009

Ingredients

Cochliobolus sativusActive

Code: 3LN5B70U4WClass: ACTIBQuantity: 0.01 g in 1 mL

Fraxinus americana pollenActive

Code: G684LX721QClass: ACTIBQuantity: 0.01 g in 1 mL

Periplaneta americanaActive

Code: 2RQ1L9N089Class: ACTIBQuantity: 0.01 g in 1 mL

Dermatophagoides farinaeActive

Code: PR9U2YPF3QClass: ACTIBQuantity: 1000 [AU] in 1 mL

Dermatophagoides pteronyssinusActive

Code: 57L1Z5378KClass: ACTIBQuantity: 1000 [AU] in 1 mL

Iva annua pollenActive

Code: Y2U5S5PF22Class: ACTIBQuantity: 0.01 g in 1 mL

Salsola kali pollenActive

Code: 2MH135KC6GClass: ACTIBQuantity: 0.01 g in 1 mL

Candida albicansActive

Code: 4D7G21HDBCClass: ACTIBQuantity: 0.01 g in 1 mL

WATERInactive

Code: 059QF0KO0RClass: IACT

PHENOLInactive

Code: 339NCG44TVClass: IACT

GLYCERINInactive

Code: PDC6A3C0OXClass: IACT

SODIUM CHLORIDEInactive

Code: 451W47IQ8XClass: IACT

SODIUM BICARBONATEInactive

Code: 8MDF5V39QOClass: IACT

Treatment Set TS330156

NDC Product Code

49288-0766

Application Number

BLA102223

Marketing Category

BLA (C73585)

Route of Administration

SUBCUTANEOUS, INTRADERMAL

Effective Date

December 2, 2009

Ingredients

Ambrosia psilostachya pollenActive

Code: RX18M46K8LClass: ACTIBQuantity: 0.0000267 g in 1 mL

Ambrosia artemisiifolia pollenActive

Code: K20Y81ACO3Class: ACTIBQuantity: 0.0000267 g in 1 mL

Ambrosia trifida pollenActive

Code: KU1V1898XXClass: ACTIBQuantity: 0.0000267 g in 1 mL

Pecan pollenActive

Code: PYO4JR720YClass: ACTIBQuantity: 0.001 g in 1 mL

Pleospora herbarumActive

Code: 0N3Z1P4B2WClass: ACTIBQuantity: 0.00008 g in 1 mL

Carya tomentosa pollenActive

Code: G2A764T54BClass: ACTIBQuantity: 0.001 g in 1 mL

Ustilago nuda hordeiActive

Code: 9Y53ZS6I82Class: ACTIBQuantity: 0.0001 g in 1 mL

Sporisorium cruentumActive

Code: GQM6LVU5V8Class: ACTIBQuantity: 0.001 g in 1 mL

Cladosporium cladosporioidesActive

Code: 4ZWY20GTGOClass: ACTIBQuantity: 0.002 g in 1 mL

Ustilago maydisActive

Code: 4K7Z7K7SWGClass: ACTIBQuantity: 0.0001 g in 1 mL

Ustilago avenaeActive

Code: YIH315U1TUClass: ACTIBQuantity: 0.0001 g in 1 mL

Ustilago triticiActive

Code: BV82OL2IZ8Class: ACTIBQuantity: 0.0001 g in 1 mL

Ustilago cynodontisActive

Code: 0V3J4YEX2WClass: ACTIBQuantity: 0.001 g in 1 mL

Ulmus americana pollenActive

Code: 89BAT511BDClass: ACTIBQuantity: 0.002 g in 1 mL

Felis catus hairActive

Code: 1564HD0N96Class: ACTIBQuantity: 16 [BAU] in 1 mL

Alternaria alternataActive

Code: 52B29REC7HClass: ACTIBQuantity: 0.002 g in 1 mL

Poa pratensis pollenActive

Code: SCB8J7LS3TClass: ACTIBQuantity: 160 [BAU] in 1 mL

Fusarium oxysporumActive

Code: 5398RXP8KUClass: ACTIBQuantity: 0.002 g in 1 mL

Candida albicansActive

Code: 4D7G21HDBCClass: ACTIBQuantity: 0.00008 g in 1 mL

Acer negundo pollenActive

Code: P6K070AR8VClass: ACTIBQuantity: 0.002 g in 1 mL

Betula nigra pollenActive

Code: 93963RFO1PClass: ACTIBQuantity: 0.002 g in 1 mL

WATERInactive

Code: 059QF0KO0RClass: IACT

PHENOLInactive

Code: 339NCG44TVClass: IACT

SODIUM BICARBONATEInactive

Code: 8MDF5V39QOClass: IACT

GLYCERINInactive

Code: PDC6A3C0OXClass: IACT

Quercus alba pollenActive

Code: Z4Y9ZSV4KKClass: ACTIBQuantity: 0.002 g in 1 mL

Fraxinus americana pollenActive

Code: G684LX721QClass: ACTIBQuantity: 0.002 g in 1 mL

Cynodon dactylon pollenActive

Code: 175F461W10Class: ACTIBQuantity: 16 [BAU] in 1 mL

Sorghum halepense pollenActive

Code: 577VA5B4HPClass: ACTIBQuantity: 0.00008 g in 1 mL

Bassia scoparia pollenActive

Code: 07A108ZKW5Class: ACTIBQuantity: 0.002 g in 1 mL

Salsola kali pollenActive

Code: 2MH135KC6GClass: ACTIBQuantity: 0.002 g in 1 mL

SODIUM CHLORIDEInactive

Code: 451W47IQ8XClass: IACT

Treatment Set TS330821

NDC Product Code

49288-0765

Application Number

BLA102223

Marketing Category

BLA (C73585)

Route of Administration

SUBCUTANEOUS, INTRADERMAL

Effective Date

December 2, 2009

Ingredients

Ambrosia trifida pollenActive

Code: KU1V1898XXClass: ACTIBQuantity: 0.0000267 g in 1 mL

Ambrosia artemisiifolia pollenActive

Code: K20Y81ACO3Class: ACTIBQuantity: 0.0000267 g in 1 mL

Ustilago cynodontisActive

Code: 0V3J4YEX2WClass: ACTIBQuantity: 0.001 g in 1 mL

Ambrosia psilostachya pollenActive

Code: RX18M46K8LClass: ACTIBQuantity: 0.0000267 g in 1 mL

Sporisorium cruentumActive

Code: GQM6LVU5V8Class: ACTIBQuantity: 0.001 g in 1 mL

Anas platyrhynchos featherActive

Code: 83B65P4796Class: ACTIBQuantity: 0.00067 g in 1 mL

Gallus gallus featherActive

Code: 1FCM16V0FVClass: ACTIBQuantity: 0.00067 g in 1 mL

Juniperus virginiana pollenActive

Code: PY0JA16R2GClass: ACTIBQuantity: 0.00008 g in 1 mL

Anser anser featherActive

Code: 15XI414745Class: ACTIBQuantity: 0.00067 g in 1 mL

Ulmus americana pollenActive

Code: 89BAT511BDClass: ACTIBQuantity: 0.002 g in 1 mL

Poa pratensis pollenActive

Code: SCB8J7LS3TClass: ACTIBQuantity: 160 [BAU] in 1 mL

Plantago lanceolata pollenActive

Code: DO87T1U2CIClass: ACTIBQuantity: 0.002 g in 1 mL

Felis catus hairActive

Code: 1564HD0N96Class: ACTIBQuantity: 16 [BAU] in 1 mL

Periplaneta americanaActive

Code: 2RQ1L9N089Class: ACTIBQuantity: 0.002 g in 1 mL

Dermatophagoides farinaeActive

Code: PR9U2YPF3QClass: ACTIBQuantity: 16 [AU] in 1 mL

Alternaria alternataActive

Code: 52B29REC7HClass: ACTIBQuantity: 0.002 g in 1 mL

Candida albicansActive

Code: 4D7G21HDBCClass: ACTIBQuantity: 0.00008 g in 1 mL

Cynodon dactylon pollenActive

Code: 175F461W10Class: ACTIBQuantity: 400 [BAU] in 1 mL

Acer negundo pollenActive

Code: P6K070AR8VClass: ACTIBQuantity: 0.002 g in 1 mL

Dermatophagoides pteronyssinusActive

Code: 57L1Z5378KClass: ACTIBQuantity: 400 [AU] in 1 mL

Betula nigra pollenActive

Code: 93963RFO1PClass: ACTIBQuantity: 0.002 g in 1 mL

Sorghum halepense pollenActive

Code: 577VA5B4HPClass: ACTIBQuantity: 0.002 g in 1 mL

Chenopodium album pollenActive

Code: 098LKX5NCNClass: ACTIBQuantity: 0.002 g in 1 mL

WATERInactive

Code: 059QF0KO0RClass: IACT

Iva annua pollenActive

Code: Y2U5S5PF22Class: ACTIBQuantity: 0.002 g in 1 mL

GLYCERINInactive

Code: PDC6A3C0OXClass: IACT

PHENOLInactive

Code: 339NCG44TVClass: IACT

SODIUM CHLORIDEInactive

Code: 451W47IQ8XClass: IACT

SODIUM BICARBONATEInactive

Code: 8MDF5V39QOClass: IACT

Treatment Set TS329240

NDC Product Code

49288-0763

Application Number

BLA102223

Marketing Category

BLA (C73585)

Route of Administration

SUBCUTANEOUS, INTRADERMAL

Effective Date

December 2, 2009

Ingredients

Ambrosia artemisiifolia pollenActive

Code: K20Y81ACO3Class: ACTIBQuantity: 0.0000267 g in 1 mL

Ambrosia trifida pollenActive

Code: KU1V1898XXClass: ACTIBQuantity: 0.0000267 g in 1 mL

Pecan pollenActive

Code: PYO4JR720YClass: ACTIBQuantity: 0.00004 g in 1 mL

Penicillium chrysogenum var. chrysogenumActive

Code: 3Y1PE1GCIGClass: ACTIBQuantity: 0.0004 g in 1 mL

Carya tomentosa pollenActive

Code: G2A764T54BClass: ACTIBQuantity: 0.00004 g in 1 mL

Pleospora herbarumActive

Code: 0N3Z1P4B2WClass: ACTIBQuantity: 0.00008 g in 1 mL

Juniperus virginiana pollenActive

Code: PY0JA16R2GClass: ACTIBQuantity: 0.00008 g in 1 mL

Quercus alba pollenActive

Code: Z4Y9ZSV4KKClass: ACTIBQuantity: 0.00008 g in 1 mL

Fraxinus americana pollenActive

Code: G684LX721QClass: ACTIBQuantity: 0.00008 g in 1 mL

Poa pratensis pollenActive

Code: SCB8J7LS3TClass: ACTIBQuantity: 160 [BAU] in 1 mL

Cynodon dactylon pollenActive

Code: 175F461W10Class: ACTIBQuantity: 80 [BAU] in 1 mL

Populus deltoides pollenActive

Code: 476DVV63WPClass: ACTIBQuantity: 0.00008 g in 1 mL

Dermatophagoides pteronyssinusActive

Code: 57L1Z5378KClass: ACTIBQuantity: 400 [AU] in 1 mL

Candida albicansActive

Code: 4D7G21HDBCClass: ACTIBQuantity: 0.002 g in 1 mL

Plantago lanceolata pollenActive

Code: DO87T1U2CIClass: ACTIBQuantity: 0.0004 g in 1 mL

Phoma destructivaActive

Code: A17SE577FMClass: ACTIBQuantity: 0.00008 g in 1 mL

Sorghum halepense pollenActive

Code: 577VA5B4HPClass: ACTIBQuantity: 0.002 g in 1 mL

Bassia scoparia pollenActive

Code: 07A108ZKW5Class: ACTIBQuantity: 0.002 g in 1 mL

Acer negundo pollenActive

Code: P6K070AR8VClass: ACTIBQuantity: 0.00008 g in 1 mL

Iva annua pollenActive

Code: Y2U5S5PF22Class: ACTIBQuantity: 0.002 g in 1 mL

Betula nigra pollenActive

Code: 93963RFO1PClass: ACTIBQuantity: 0.00008 g in 1 mL

Amaranthus retroflexus pollenActive

Code: 73B14PX5FWClass: ACTIBQuantity: 0.002 g in 1 mL

Chenopodium album pollenActive

Code: 098LKX5NCNClass: ACTIBQuantity: 0.0004 g in 1 mL

Salsola kali pollenActive

Code: 2MH135KC6GClass: ACTIBQuantity: 0.0004 g in 1 mL

WATERInactive

Code: 059QF0KO0RClass: IACT

SODIUM CHLORIDEInactive

Code: 451W47IQ8XClass: IACT

PHENOLInactive

Code: 339NCG44TVClass: IACT

GLYCERINInactive

Code: PDC6A3C0OXClass: IACT

SODIUM BICARBONATEInactive

Code: 8MDF5V39QOClass: IACT

Ambrosia psilostachya pollenActive

Code: RX18M46K8LClass: ACTIBQuantity: 0.0000267 g in 1 mL

Ulmus americana pollenActive

Code: 89BAT511BDClass: ACTIBQuantity: 0.00008 g in 1 mL

Treatment Set TS333375

NDC Product Code

49288-0764

Application Number

BLA102223

Marketing Category

BLA (C73585)

Route of Administration

SUBCUTANEOUS, INTRADERMAL

Effective Date

December 2, 2009

Ingredients

Ambrosia psilostachya pollenActive

Code: RX18M46K8LClass: ACTIBQuantity: 0.0000267 g in 1 mL

Ambrosia artemisiifolia pollenActive

Code: K20Y81ACO3Class: ACTIBQuantity: 0.0000267 g in 1 mL

Ambrosia trifida pollenActive

Code: KU1V1898XXClass: ACTIBQuantity: 0.0000267 g in 1 mL

Carya tomentosa pollenActive

Code: G2A764T54BClass: ACTIBQuantity: 0.00004 g in 1 mL

Pecan pollenActive

Code: PYO4JR720YClass: ACTIBQuantity: 0.00004 g in 1 mL

Juniperus virginiana pollenActive

Code: PY0JA16R2GClass: ACTIBQuantity: 0.00008 g in 1 mL

Quercus alba pollenActive

Code: Z4Y9ZSV4KKClass: ACTIBQuantity: 0.002 g in 1 mL

Ulmus americana pollenActive

Code: 89BAT511BDClass: ACTIBQuantity: 0.0004 g in 1 mL

Plantago lanceolata pollenActive

Code: DO87T1U2CIClass: ACTIBQuantity: 0.002 g in 1 mL

Cynodon dactylon pollenActive

Code: 175F461W10Class: ACTIBQuantity: 80 [BAU] in 1 mL

Fraxinus americana pollenActive

Code: G684LX721QClass: ACTIBQuantity: 0.00008 g in 1 mL

Poa pratensis pollenActive

Code: SCB8J7LS3TClass: ACTIBQuantity: 160 [BAU] in 1 mL

Betula nigra pollenActive

Code: 93963RFO1PClass: ACTIBQuantity: 0.0004 g in 1 mL

Populus deltoides pollenActive

Code: 476DVV63WPClass: ACTIBQuantity: 0.00008 g in 1 mL

Sorghum halepense pollenActive

Code: 577VA5B4HPClass: ACTIBQuantity: 0.00008 g in 1 mL

Acer negundo pollenActive

Code: P6K070AR8VClass: ACTIBQuantity: 0.00008 g in 1 mL

Amaranthus retroflexus pollenActive

Code: 73B14PX5FWClass: ACTIBQuantity: 0.00008 g in 1 mL

Salsola kali pollenActive

Code: 2MH135KC6GClass: ACTIBQuantity: 0.002 g in 1 mL

Bassia scoparia pollenActive

Code: 07A108ZKW5Class: ACTIBQuantity: 0.002 g in 1 mL

Iva annua pollenActive

Code: Y2U5S5PF22Class: ACTIBQuantity: 0.00008 g in 1 mL

Rumex acetosella pollenActive

Code: N52MIQ81ZWClass: ACTIBQuantity: 0.00008 g in 1 mL

WATERInactive

Code: 059QF0KO0RClass: IACT

Chenopodium album pollenActive

Code: 098LKX5NCNClass: ACTIBQuantity: 0.00008 g in 1 mL

GLYCERINInactive

Code: PDC6A3C0OXClass: IACT

SODIUM CHLORIDEInactive

Code: 451W47IQ8XClass: IACT

PHENOLInactive

Code: 339NCG44TVClass: IACT

SODIUM BICARBONATEInactive

Code: 8MDF5V39QOClass: IACT

Treatment Set TS333373

NDC Product Code

49288-0760

Application Number

BLA102223

Marketing Category

BLA (C73585)

Route of Administration

SUBCUTANEOUS, INTRADERMAL

Effective Date

December 2, 2009

Ingredients

Gallus gallus featherActive

Code: 1FCM16V0FVClass: ACTIBQuantity: 0.00067 g in 1 mL

Anas platyrhynchos featherActive

Code: 83B65P4796Class: ACTIBQuantity: 0.00067 g in 1 mL

Anser anser featherActive

Code: 15XI414745Class: ACTIBQuantity: 0.00067 g in 1 mL

Ustilago nuda hordeiActive

Code: 9Y53ZS6I82Class: ACTIBQuantity: 0.00002 g in 1 mL

Ustilago avenaeActive

Code: YIH315U1TUClass: ACTIBQuantity: 0.00002 g in 1 mL

Ustilago maydisActive

Code: 4K7Z7K7SWGClass: ACTIBQuantity: 0.00002 g in 1 mL

Cladosporium cladosporioidesActive

Code: 4ZWY20GTGOClass: ACTIBQuantity: 0.002 g in 1 mL

Ustilago triticiActive

Code: BV82OL2IZ8Class: ACTIBQuantity: 0.00002 g in 1 mL

Cochliobolus sativusActive

Code: 3LN5B70U4WClass: ACTIBQuantity: 0.002 g in 1 mL

Aureobasidium pullulans var. pullutansActive

Code: D1A2NG69CKClass: ACTIBQuantity: 0.002 g in 1 mL

Pleospora herbarumActive

Code: 0N3Z1P4B2WClass: ACTIBQuantity: 0.00008 g in 1 mL

Felis catus hairActive

Code: 1564HD0N96Class: ACTIBQuantity: 400 [BAU] in 1 mL

Penicillium chrysogenum var. chrysogenumActive

Code: 3Y1PE1GCIGClass: ACTIBQuantity: 0.002 g in 1 mL

Alternaria alternataActive

Code: 52B29REC7HClass: ACTIBQuantity: 0.002 g in 1 mL

Dermatophagoides farinaeActive

Code: PR9U2YPF3QClass: ACTIBQuantity: 400 [AU] in 1 mL

Dermatophagoides pteronyssinusActive

Code: 57L1Z5378KClass: ACTIBQuantity: 16 [AU] in 1 mL

Canis lupus familiaris hairActive

Code: 05S7L91ZTRClass: ACTIBQuantity: 0.00008 g in 1 mL

Periplaneta americanaActive

Code: 2RQ1L9N089Class: ACTIBQuantity: 0.00008 g in 1 mL

Aspergillus fumigatusActive

Code: X88DF51T48Class: ACTIBQuantity: 0.00008 g in 1 mL

Candida albicansActive

Code: 4D7G21HDBCClass: ACTIBQuantity: 0.00008 g in 1 mL

Phoma destructivaActive

Code: A17SE577FMClass: ACTIBQuantity: 0.002 g in 1 mL

Fusarium oxysporumActive

Code: 5398RXP8KUClass: ACTIBQuantity: 0.00008 g in 1 mL

Rhizopus stoloniferActive

Code: FEE198DK4QClass: ACTIBQuantity: 0.00008 g in 1 mL

WATERInactive

Code: 059QF0KO0RClass: IACT

SODIUM BICARBONATEInactive

Code: 8MDF5V39QOClass: IACT

PHENOLInactive

Code: 339NCG44TVClass: IACT

GLYCERINInactive

Code: PDC6A3C0OXClass: IACT

SODIUM CHLORIDEInactive

Code: 451W47IQ8XClass: IACT

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Products (59)

Treatment Set TS331795

Treatment Set TS334696

Treatment Set TS331796

Treatment Set TS332679

Treatment Set TS329413

Treatment Set TS330156

Treatment Set TS330821

Treatment Set TS329240

Treatment Set TS333375

Treatment Set TS333373