MedPath
FDA Approval

Treatment Set TS345463

May 11, 2012

HUMAN PRESCRIPTION DRUG LABEL

Dermatophagoides farinae(1000 [AU] in 1 mL)
Phleum pratense pollen(4000 [BAU] in 1 mL)
Cynodon dactylon pollen(1000 [BAU] in 1 mL)
Iva annua pollen(0.005 g in 1 mL)

Registrants (1)

Antigen Laboratories, Inc.

030705628

Manufacturing Establishments (1)

Antigen Laboratories, Inc.

Antigen Laboratories, Inc.

Antigen Laboratories, Inc.

030705628

Products (7)

Treatment Set TS346157

49288-0854

BLA102223

BLA (C73585)

SUBCUTANEOUS, INTRADERMAL

May 11, 2012

Code: PR9U2YPF3QClass: ACTIBQuantity: 1000 [AU] in 1 mL
Code: 65M88RW2EGClass: ACTIBQuantity: 4000 [BAU] in 1 mL
Code: 57L1Z5378KClass: ACTIBQuantity: 1000 [AU] in 1 mL
Code: 05S7L91ZTRClass: ACTIBQuantity: 0.005 g in 1 mL
Code: 175F461W10Class: ACTIBQuantity: 1000 [BAU] in 1 mL
Code: K20Y81ACO3Class: ACTIBQuantity: 4000 [AU] in 1 mL
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QOClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
GLYCERINInactive
Code: PDC6A3C0OXClass: IACT
PHENOLInactive
Code: 339NCG44TVClass: IACT
Code: Y2U5S5PF22Class: ACTIBQuantity: 0.005 g in 1 mL

Treatment Set TS345825

49288-0852

BLA102223

BLA (C73585)

SUBCUTANEOUS, INTRADERMAL

May 11, 2012

Code: 1564HD0N96Class: ACTIBQuantity: 400 [BAU] in 1 mL
Code: 175F461W10Class: ACTIBQuantity: 16 [BAU] in 1 mL
Code: SCB8J7LS3TClass: ACTIBQuantity: 160 [BAU] in 1 mL
Code: 577VA5B4HPClass: ACTIBQuantity: 0.00008 g in 1 mL
Code: E03U1K03LKClass: ACTIBQuantity: 0.0004 g in 1 mL
Code: Z4Y9ZSV4KKClass: ACTIBQuantity: 0.00008 g in 1 mL
Code: 89BAT511BDClass: ACTIBQuantity: 0.0004 g in 1 mL
Code: G2A764T54BClass: ACTIBQuantity: 0.0004 g in 1 mL
Code: 3I9T68187HClass: ACTIBQuantity: 0.0004 g in 1 mL
Code: P6K070AR8VClass: ACTIBQuantity: 0.0004 g in 1 mL
Code: K20Y81ACO3Class: ACTIBQuantity: 160 [AU] in 1 mL
Code: 544F8MEY0YClass: ACTIBQuantity: 0.002 g in 1 mL
Code: 2MH135KC6GClass: ACTIBQuantity: 0.0004 g in 1 mL
Code: DNB59M1NVUClass: ACTIBQuantity: 0.002 g in 1 mL
GLYCERINInactive
Code: PDC6A3C0OXClass: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QOClass: IACT
PHENOLInactive
Code: 339NCG44TVClass: IACT
Code: DO87T1U2CIClass: ACTIBQuantity: 0.0004 g in 1 mL
Code: 73B14PX5FWClass: ACTIBQuantity: 0.0004 g in 1 mL
Code: N52MIQ81ZWClass: ACTIBQuantity: 0.002 g in 1 mL

Treatment Set TS345784

49288-0851

BLA102223

BLA (C73585)

INTRADERMAL, SUBCUTANEOUS

May 11, 2012

Code: 57L1Z5378KClass: ACTIBQuantity: 400 [AU] in 1 mL
Code: PR9U2YPF3QClass: ACTIBQuantity: 400 [AU] in 1 mL
Code: 65M88RW2EGClass: ACTIBQuantity: 160 [BAU] in 1 mL
Code: K20Y81ACO3Class: ACTIBQuantity: 800 [AU] in 1 mL
Code: P6K070AR8VClass: ACTIBQuantity: 0.0004 g in 1 mL
Code: A0WFQ8P6N1Class: ACTIBQuantity: 800 [BAU] in 1 mL
Code: 577VA5B4HPClass: ACTIBQuantity: 0.002 g in 1 mL
Code: A7IKY24TR7Class: ACTIBQuantity: 0.0004 g in 1 mL
Code: 6AU0ZD8T1OClass: ACTIBQuantity: 0.002 g in 1 mL
Code: G2A764T54BClass: ACTIBQuantity: 0.0002 g in 1 mL
GLYCERINInactive
Code: PDC6A3C0OXClass: IACT
Code: 1564HD0N96Class: ACTIBQuantity: 400 [BAU] in 1 mL
PHENOLInactive
Code: 339NCG44TVClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
Code: PYO4JR720YClass: ACTIBQuantity: 0.0002 g in 1 mL
Code: 2RQ1L9N089Class: ACTIBQuantity: 0.00008 g in 1 mL
SODIUM BICARBONATEInactive
Code: 8MDF5V39QOClass: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT

Treatment Set TS345694

49288-0850

BLA102223

BLA (C73585)

INTRADERMAL, SUBCUTANEOUS

May 11, 2012

Code: 52B29REC7HClass: ACTIBQuantity: 0.002 g in 1 mL
Code: 05S7L91ZTRClass: ACTIBQuantity: 0.002 g in 1 mL
Code: 1564HD0N96Class: ACTIBQuantity: 80 [BAU] in 1 mL
Code: K20Y81ACO3Class: ACTIBQuantity: 800 [AU] in 1 mL
Code: 57L1Z5378KClass: ACTIBQuantity: 80 [AU] in 1 mL
Code: PR9U2YPF3QClass: ACTIBQuantity: 80 [AU] in 1 mL
Code: 175F461W10Class: ACTIBQuantity: 400 [BAU] in 1 mL
Code: A0WFQ8P6N1Class: ACTIBQuantity: 4000 [BAU] in 1 mL
Code: G2A764T54BClass: ACTIBQuantity: 0.0002 g in 1 mL
Code: PYO4JR720YClass: ACTIBQuantity: 0.0002 g in 1 mL
Code: N52MIQ81ZWClass: ACTIBQuantity: 0.002 g in 1 mL
Code: 65M88RW2EGClass: ACTIBQuantity: 4000 [BAU] in 1 mL
Code: G684LX721QClass: ACTIBQuantity: 0.002 g in 1 mL
Code: Z4Y9ZSV4KKClass: ACTIBQuantity: 0.0004 g in 1 mL
Code: 476DVV63WPClass: ACTIBQuantity: 0.002 g in 1 mL
Code: 4F35XG0149Class: ACTIBQuantity: 0.00008 g in 1 mL
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
Code: P6K070AR8VClass: ACTIBQuantity: 0.002 g in 1 mL
SODIUM BICARBONATEInactive
Code: 8MDF5V39QOClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
GLYCERINInactive
Code: PDC6A3C0OXClass: IACT
PHENOLInactive
Code: 339NCG44TVClass: IACT

Treatment Set TS345883

49288-0853

BLA102223

BLA (C73585)

SUBCUTANEOUS, INTRADERMAL

May 11, 2012

Code: DNB59M1NVUClass: ACTIBQuantity: 0.0004 g in 1 mL
Code: 73B14PX5FWClass: ACTIBQuantity: 0.002 g in 1 mL
Code: 098LKX5NCNClass: ACTIBQuantity: 0.0004 g in 1 mL
Code: K20Y81ACO3Class: ACTIBQuantity: 4000 [AU] in 1 mL
Code: N52MIQ81ZWClass: ACTIBQuantity: 0.00008 g in 1 mL
Code: 65M88RW2EGClass: ACTIBQuantity: 800 [BAU] in 1 mL
Code: 6AU0ZD8T1OClass: ACTIBQuantity: 0.002 g in 1 mL
Code: 23H70FYJ5UClass: ACTIBQuantity: 0.002 g in 1 mL
Code: P6K070AR8VClass: ACTIBQuantity: 0.00008 g in 1 mL
Code: PY0JA16R2GClass: ACTIBQuantity: 0.0004 g in 1 mL
Code: 476DVV63WPClass: ACTIBQuantity: 0.0004 g in 1 mL
Code: 4F35XG0149Class: ACTIBQuantity: 0.01 g in 1 mL
Code: PYO4JR720YClass: ACTIBQuantity: 0.00004 g in 1 mL
Code: G2A764T54BClass: ACTIBQuantity: 0.00004 g in 1 mL
Code: 52B29REC7HClass: ACTIBQuantity: 0.002 g in 1 mL
Code: 1564HD0N96Class: ACTIBQuantity: 400 [BAU] in 1 mL
Code: 57L1Z5378KClass: ACTIBQuantity: 16 [AU] in 1 mL
Code: 2RQ1L9N089Class: ACTIBQuantity: 0.0004 g in 1 mL
SODIUM BICARBONATEInactive
Code: 8MDF5V39QOClass: IACT
PHENOLInactive
Code: 339NCG44TVClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
GLYCERINInactive
Code: PDC6A3C0OXClass: IACT
Code: G684LX721QClass: ACTIBQuantity: 0.00008 g in 1 mL
Code: Z4Y9ZSV4KKClass: ACTIBQuantity: 0.00008 g in 1 mL

Treatment Set TS345476

49288-0849

BLA102223

BLA (C73585)

SUBCUTANEOUS, INTRADERMAL

May 11, 2012

Code: K20Y81ACO3Class: ACTIBQuantity: 4000 g in 1 mL
Code: 175F461W10Class: ACTIBQuantity: 1000 [BAU] in 1 mL
Code: G2A764T54BClass: ACTIBQuantity: 0.005 g in 1 mL
Code: PR9U2YPF3QClass: ACTIBQuantity: 1000 [AU] in 1 mL
Code: 1564HD0N96Class: ACTIBQuantity: 400 [BAU] in 1 mL
Code: 0N3Z1P4B2WClass: ACTIBQuantity: 0.005 g in 1 mL
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
GLYCERINInactive
Code: PDC6A3C0OXClass: IACT
Code: N52MIQ81ZWClass: ACTIBQuantity: 0.005 g in 1 mL
WATERInactive
Code: 059QF0KO0RClass: IACT
PHENOLInactive
Code: 339NCG44TVClass: IACT
Code: 3Y1PE1GCIGClass: ACTIBQuantity: 0.005 g in 1 mL
Code: 52B29REC7HClass: ACTIBQuantity: 0.002 g in 1 mL
Code: 81GS97HVFOClass: ACTIBQuantity: 0.005 g in 1 mL
SODIUM BICARBONATEInactive
Code: 8MDF5V39QOClass: IACT

Treatment Set TS345463

49288-0848

BLA102223

BLA (C73585)

SUBCUTANEOUS, INTRADERMAL

May 11, 2012

Code: 175F461W10Class: ACTIBQuantity: 16 [BAU] in 1 mL
Code: PYO4JR720YClass: ACTIBQuantity: 0.001 g in 1 mL
Code: 73B14PX5FWClass: ACTIBQuantity: 0.002 g in 1 mL
Code: K20Y81ACO3Class: ACTIBQuantity: 160 [AU] in 1 mL
Code: G2A764T54BClass: ACTIBQuantity: 0.001 g in 1 mL
Code: N52MIQ81ZWClass: ACTIBQuantity: 0.0004 g in 1 mL
Code: 2RQ1L9N089Class: ACTIBQuantity: 0.002 g in 1 mL
Code: A7IKY24TR7Class: ACTIBQuantity: 0.002 g in 1 mL
Code: 6AU0ZD8T1OClass: ACTIBQuantity: 0.0004 g in 1 mL
Code: 65M88RW2EGClass: ACTIBQuantity: 160 [BAU] in 1 mL
WATERInactive
Code: 059QF0KO0RClass: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QOClass: IACT
GLYCERINInactive
Code: PDC6A3C0OXClass: IACT
PHENOLInactive
Code: 339NCG44TVClass: IACT
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