MedPath
FDA Approval

Treatment Set TS336437

June 17, 2010

HUMAN PRESCRIPTION DRUG LABEL

Alternaria alternata(0.002 g in 1 mL)
Ambrosia trifida pollen(0.0000266 g in 1 mL)
Carya tomentosa pollen(0.00004 g in 1 mL)
Ambrosia artemisiifolia pollen(0.0000266 g in 1 mL)
Ambrosia psilostachya pollen(0.0000266 g in 1 mL)
Pecan pollen(0.00004 g in 1 mL)
Juniperus virginiana pollen(0.00008 g in 1 mL)
Pleospora herbarum(0.00008 g in 1 mL)
Quercus alba pollen(0.00008 g in 1 mL)
Betula nigra pollen(0.00008 g in 1 mL)
Chenopodium album pollen(0.00008 g in 1 mL)
Bassia scoparia pollen(0.00008 g in 1 mL)
Iva annua pollen(0.00008 g in 1 mL)
Salsola kali pollen(0.00008 g in 1 mL)
Ustilago nuda hordei(0.00002 g in 1 mL)
Ustilago avenae(0.00002 g in 1 mL)
Ustilago maydis(0.00002 g in 1 mL)
Ustilago tritici(0.00002 g in 1 mL)
Poa pratensis pollen(160 [BAU] in 1 mL)
Ustilago cynodontis(0.0002 g in 1 mL)
Cynodon dactylon pollen(16 [BAU] in 1 mL)
Sporisorium cruentum(0.0002 g in 1 mL)
Ulmus americana pollen(0.002 g in 1 mL)
Plantago lanceolata pollen(0.00008 g in 1 mL)
Acer negundo pollen(0.0008 g in 1 mL)
Populus deltoides pollen(0.00008 g in 1 mL)
Rumex acetosella pollen(0.00008 g in 1 mL)
Fraxinus americana pollen(0.00008 g in 1 mL)
Sorghum halepense pollen(0.00008 g in 1 mL)

Registrants (1)

Antigen Laboratories, Inc.

030705628

Manufacturing Establishments (1)

Antigen Laboratories, Inc.

Antigen Laboratories, Inc.

Antigen Laboratories, Inc.

030705628

Products (1)

Treatment Set TS336437

49288-0786

BLA102223

BLA (C73585)

SUBCUTANEOUS, INTRADERMAL

June 17, 2010

Code: 52B29REC7HClass: ACTIBQuantity: 0.002 g in 1 mL
Code: KU1V1898XXClass: ACTIBQuantity: 0.0000266 g in 1 mL
Code: 57L1Z5378KClass: ACTIBQuantity: 400 [AU] in 1 mL
Code: G2A764T54BClass: ACTIBQuantity: 0.00004 g in 1 mL
Code: K20Y81ACO3Class: ACTIBQuantity: 0.0000266 g in 1 mL
Code: RX18M46K8LClass: ACTIBQuantity: 0.0000266 g in 1 mL
Code: PYO4JR720YClass: ACTIBQuantity: 0.00004 g in 1 mL
Code: PY0JA16R2GClass: ACTIBQuantity: 0.00008 g in 1 mL
Code: 0N3Z1P4B2WClass: ACTIBQuantity: 0.00008 g in 1 mL
Code: Z4Y9ZSV4KKClass: ACTIBQuantity: 0.00008 g in 1 mL
Code: 93963RFO1PClass: ACTIBQuantity: 0.00008 g in 1 mL
Code: 098LKX5NCNClass: ACTIBQuantity: 0.00008 g in 1 mL
Code: 07A108ZKW5Class: ACTIBQuantity: 0.00008 g in 1 mL
Code: Y2U5S5PF22Class: ACTIBQuantity: 0.00008 g in 1 mL
Code: 2MH135KC6GClass: ACTIBQuantity: 0.00008 g in 1 mL
Code: 73B14PX5FWClass: ACTIBQuantity: 0.00008 g in 1 mL
Code: 9Y53ZS6I82Class: ACTIBQuantity: 0.00002 g in 1 mL
Code: YIH315U1TUClass: ACTIBQuantity: 0.00002 g in 1 mL
Code: 4K7Z7K7SWGClass: ACTIBQuantity: 0.00002 g in 1 mL
Code: BV82OL2IZ8Class: ACTIBQuantity: 0.00002 g in 1 mL
Code: SCB8J7LS3TClass: ACTIBQuantity: 160 [BAU] in 1 mL
Code: 0V3J4YEX2WClass: ACTIBQuantity: 0.0002 g in 1 mL
Code: 175F461W10Class: ACTIBQuantity: 16 [BAU] in 1 mL
Code: GQM6LVU5V8Class: ACTIBQuantity: 0.0002 g in 1 mL
Code: 89BAT511BDClass: ACTIBQuantity: 0.002 g in 1 mL
Code: DO87T1U2CIClass: ACTIBQuantity: 0.00008 g in 1 mL
Code: P6K070AR8VClass: ACTIBQuantity: 0.0008 g in 1 mL
PHENOLInactive
Code: 339NCG44TVClass: IACT
Code: 476DVV63WPClass: ACTIBQuantity: 0.00008 g in 1 mL
Code: N52MIQ81ZWClass: ACTIBQuantity: 0.00008 g in 1 mL
Code: G684LX721QClass: ACTIBQuantity: 0.00008 g in 1 mL
Code: 577VA5B4HPClass: ACTIBQuantity: 0.00008 g in 1 mL
WATERInactive
Code: 059QF0KO0RClass: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QOClass: IACT
GLYCERINInactive
Code: PDC6A3C0OXClass: IACT
© Copyright 2025. All Rights Reserved by MedPath