Treatment Set TS339754
ALLERGENIC EXTRACTSINDIVIDUAL TREATMENT VIAL
Approved
Approval ID
e50fbed1-a782-44a7-ace6-3a0d9e4a3a8e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 15, 2011
Manufacturers
FDA
Antigen Laboratories, Inc.
DUNS: 030705628
Products 5
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Treatment Set TS340053
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code49288-0805
Application NumberBLA102223
Product Classification
M
Marketing Category
C73585
G
Generic Name
Treatment Set TS340053
Product Specifications
Route of AdministrationSUBCUTANEOUS, INTRADERMAL
Effective DateMarch 15, 2011
FDA Product Classification
INGREDIENTS (29)
FELIS CATUS HAIRActive
Quantity: 16 [BAU] in 1 mL
Code: 1564HD0N96
Classification: ACTIB
DERMATOPHAGOIDES FARINAEActive
Quantity: 16 [AU] in 1 mL
Code: PR9U2YPF3Q
Classification: ACTIB
ALTERNARIA ALTERNATAActive
Quantity: 0.00008 g in 1 mL
Code: 52B29REC7H
Classification: ACTIB
CANIS LUPUS FAMILIARIS HAIRActive
Quantity: 0.002 g in 1 mL
Code: 05S7L91ZTR
Classification: ACTIB
PERIPLANETA AMERICANAActive
Quantity: 0.00008 g in 1 mL
Code: 2RQ1L9N089
Classification: ACTIB
DERMATOPHAGOIDES PTERONYSSINUSActive
Quantity: 16 [AU] in 1 mL
Code: 57L1Z5378K
Classification: ACTIB
CLADOSPORIUM CLADOSPORIOIDESActive
Quantity: 0.002 g in 1 mL
Code: 4ZWY20GTGO
Classification: ACTIB
PHOMA DESTRUCTIVAActive
Quantity: 0.002 g in 1 mL
Code: A17SE577FM
Classification: ACTIB
ASPERGILLUS FUMIGATUSActive
Quantity: 0.00008 g in 1 mL
Code: X88DF51T48
Classification: ACTIB
RHIZOPUS STOLONIFERActive
Quantity: 0.00008 g in 1 mL
Code: FEE198DK4Q
Classification: ACTIB
COCHLIOBOLUS SATIVUSActive
Quantity: 0.01 g in 1 mL
Code: 3LN5B70U4W
Classification: ACTIB
CANDIDA ALBICANSActive
Quantity: 0.00008 g in 1 mL
Code: 4D7G21HDBC
Classification: ACTIB
AUREOBASIDIUM PULLULANS VAR. PULLUTANSActive
Quantity: 0.00008 g in 1 mL
Code: D1A2NG69CK
Classification: ACTIB
PLEOSPORA HERBARUMActive
Quantity: 0.002 g in 1 mL
Code: 0N3Z1P4B2W
Classification: ACTIB
PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUMActive
Quantity: 0.002 g in 1 mL
Code: 3Y1PE1GCIG
Classification: ACTIB
USTILAGO NUDA HORDEIActive
Quantity: 0.0005 g in 1 mL
Code: 9Y53ZS6I82
Classification: ACTIB
USTILAGO MAYDISActive
Quantity: 0.0005 g in 1 mL
Code: 4K7Z7K7SWG
Classification: ACTIB
USTILAGO AVENAEActive
Quantity: 0.0005 g in 1 mL
Code: YIH315U1TU
Classification: ACTIB
USTILAGO TRITICIActive
Quantity: 0.0005 g in 1 mL
Code: BV82OL2IZ8
Classification: ACTIB
USTILAGO CYNODONTISActive
Quantity: 0.0002 g in 1 mL
Code: 0V3J4YEX2W
Classification: ACTIB
ANAS PLATYRHYNCHOS FEATHERActive
Quantity: 0.0006666 g in 1 mL
Code: 83B65P4796
Classification: ACTIB
ANSER ANSER FEATHERActive
Quantity: 0.0006666 g in 1 mL
Code: 15XI414745
Classification: ACTIB
SPORISORIUM CRUENTUMActive
Quantity: 0.0002 g in 1 mL
Code: GQM6LVU5V8
Classification: ACTIB
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
GALLUS GALLUS FEATHERActive
Quantity: 0.0006666 g in 1 mL
Code: 1FCM16V0FV
Classification: ACTIB
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Treatment Set TS339754
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code49288-0802
Application NumberBLA102223
Product Classification
M
Marketing Category
C73585
G
Generic Name
Treatment Set TS339754
Product Specifications
Route of AdministrationSUBCUTANEOUS, INTRADERMAL
Effective DateMarch 15, 2011
FDA Product Classification
INGREDIENTS (17)
FELIS CATUS HAIRActive
Quantity: 16 [BAU] in 1 mL
Code: 1564HD0N96
Classification: ACTIB
CYNODON DACTYLON POLLENActive
Quantity: 400 [BAU] in 1 mL
Code: 175F461W10
Classification: ACTIB
SORGHUM HALEPENSE POLLENActive
Quantity: 0.002 g in 1 mL
Code: 577VA5B4HP
Classification: ACTIB
POA PRATENSIS POLLENActive
Quantity: 4000 [BAU] in 1 mL
Code: SCB8J7LS3T
Classification: ACTIB
PASPALUM NOTATUM POLLENActive
Quantity: 0.002 g in 1 mL
Code: V003SHB7VK
Classification: ACTIB
BETULA POPULIFOLIA POLLENActive
Quantity: 0.002 g in 1 mL
Code: 23H70FYJ5U
Classification: ACTIB
POPULUS DELTOIDES POLLENActive
Quantity: 0.002 g in 1 mL
Code: 476DVV63WP
Classification: ACTIB
CARYA ILLINOINENSIS POLLENActive
Quantity: 0.002 g in 1 mL
Code: PYO4JR720Y
Classification: ACTIB
CARYA ALBA POLLENActive
Quantity: 0.002 g in 1 mL
Code: G2A764T54B
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
AMBROSIA ARTEMISIIFOLIA POLLENActive
Quantity: 800 [AU] in 1 mL
Code: K20Y81ACO3
Classification: ACTIB
PLANTAGO LANCEOLATA POLLENActive
Quantity: 0.002 g in 1 mL
Code: DO87T1U2CI
Classification: ACTIB
FESTUCA PRATENSIS POLLENActive
Quantity: 4000 [BAU] in 1 mL
Code: A0WFQ8P6N1
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
Treatment Set TS339992
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code49288-0804
Application NumberBLA102223
Product Classification
M
Marketing Category
C73585
G
Generic Name
Treatment Set TS339992
Product Specifications
Route of AdministrationINTRADERMAL, SUBCUTANEOUS
Effective DateMarch 15, 2011
FDA Product Classification
INGREDIENTS (14)
CYNODON DACTYLON POLLENActive
Quantity: 1000 [BAU] in 1 mL
Code: 175F461W10
Classification: ACTIB
DERMATOPHAGOIDES PTERONYSSINUSActive
Quantity: 400 [AU] in 1 mL
Code: 57L1Z5378K
Classification: ACTIB
AMBROSIA ARTEMISIIFOLIA POLLENActive
Quantity: 10000 [AU] in 1 mL
Code: K20Y81ACO3
Classification: ACTIB
DERMATOPHAGOIDES FARINAEActive
Quantity: 400 [AU] in 1 mL
Code: PR9U2YPF3Q
Classification: ACTIB
IVA ANNUA VAR. ANNUA POLLENActive
Quantity: 0.005 g in 1 mL
Code: Y2U5S5PF22
Classification: ACTIB
JUNIPERUS ASHEI POLLENActive
Quantity: 0.002 g in 1 mL
Code: 544F8MEY0Y
Classification: ACTIB
PHLEUM PRATENSE POLLENActive
Quantity: 4000 [BAU] in 1 mL
Code: 65M88RW2EG
Classification: ACTIB
ULMUS AMERICANA POLLENActive
Quantity: 0.005 g in 1 mL
Code: 89BAT511BD
Classification: ACTIB
ACER NEGUNDO POLLENActive
Quantity: 0.005 g in 1 mL
Code: P6K070AR8V
Classification: ACTIB
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
Treatment Set TS339813
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code49288-0803
Application NumberBLA102223
Product Classification
M
Marketing Category
C73585
G
Generic Name
Treatment Set TS339813
Product Specifications
Route of AdministrationINTRADERMAL, SUBCUTANEOUS
Effective DateMarch 15, 2011
FDA Product Classification
INGREDIENTS (10)
ALTERNARIA ALTERNATAActive
Quantity: 0.002 g in 1 mL
Code: 52B29REC7H
Classification: ACTIB
FELIS CATUS HAIRActive
Quantity: 400 [BAU] in 1 mL
Code: 1564HD0N96
Classification: ACTIB
IVA ANNUA VAR. ANNUA POLLENActive
Quantity: 0.002 g in 1 mL
Code: Y2U5S5PF22
Classification: ACTIB
CANIS LUPUS FAMILIARIS HAIRActive
Quantity: 0.002 g in 1 mL
Code: 05S7L91ZTR
Classification: ACTIB
JUNIPERUS ASHEI POLLENActive
Quantity: 0.002 g in 1 mL
Code: 544F8MEY0Y
Classification: ACTIB
AMBROSIA ARTEMISIIFOLIA POLLENActive
Quantity: 4000 [AU] in 1 mL
Code: K20Y81ACO3
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
Treatment Set TS340054
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code49288-0806
Application NumberBLA102223
Product Classification
M
Marketing Category
C73585
G
Generic Name
Treatment Set TS340054
Product Specifications
Route of AdministrationSUBCUTANEOUS, INTRADERMAL
Effective DateMarch 15, 2011
FDA Product Classification
INGREDIENTS (26)
POA PRATENSIS POLLENActive
Quantity: 160 [BAU] in 1 mL
Code: SCB8J7LS3T
Classification: ACTIB
AMBROSIA TRIFIDA POLLENActive
Quantity: 0.0000266 g in 1 mL
Code: KU1V1898XX
Classification: ACTIB
AMBROSIA ARTEMISIIFOLIA POLLENActive
Quantity: 0.0000266 g in 1 mL
Code: K20Y81ACO3
Classification: ACTIB
AMBROSIA PSILOSTACHYA POLLENActive
Quantity: 0.0000266 g in 1 mL
Code: RX18M46K8L
Classification: ACTIB
ULMUS AMERICANA POLLENActive
Quantity: 0.0004 g in 1 mL
Code: 89BAT511BD
Classification: ACTIB
CYNODON DACTYLON POLLENActive
Quantity: 16 [BAU] in 1 mL
Code: 175F461W10
Classification: ACTIB
JUNIPERUS VIRGINIANA POLLENActive
Quantity: 0.00008 g in 1 mL
Code: PY0JA16R2G
Classification: ACTIB
SORGHUM HALEPENSE POLLENActive
Quantity: 0.00008 g in 1 mL
Code: 577VA5B4HP
Classification: ACTIB
ACER NEGUNDO POLLENActive
Quantity: 0.002 g in 1 mL
Code: P6K070AR8V
Classification: ACTIB
QUERCUS ALBA POLLENActive
Quantity: 0.002 g in 1 mL
Code: Z4Y9ZSV4KK
Classification: ACTIB
CARYA ILLINOINENSIS POLLENActive
Quantity: 0.001 g in 1 mL
Code: PYO4JR720Y
Classification: ACTIB
CARYA ALBA POLLENActive
Quantity: 0.001 g in 1 mL
Code: G2A764T54B
Classification: ACTIB
BETULA NIGRA POLLENActive
Quantity: 0.002 g in 1 mL
Code: 93963RFO1P
Classification: ACTIB
PLANTAGO LANCEOLATA POLLENActive
Quantity: 0.00008 g in 1 mL
Code: DO87T1U2CI
Classification: ACTIB
POPULUS DELTOIDES POLLENActive
Quantity: 0.00008 g in 1 mL
Code: 476DVV63WP
Classification: ACTIB
FRAXINUS AMERICANA POLLENActive
Quantity: 0.002 g in 1 mL
Code: G684LX721Q
Classification: ACTIB
IVA ANNUA VAR. ANNUA POLLENActive
Quantity: 0.002 g in 1 mL
Code: Y2U5S5PF22
Classification: ACTIB
AMARANTHUS RETROFLEXUS POLLENActive
Quantity: 0.002 g in 1 mL
Code: 73B14PX5FW
Classification: ACTIB
SALSOLA KALI POLLENActive
Quantity: 0.0004 g in 1 mL
Code: 2MH135KC6G
Classification: ACTIB
KOCHIA SCOPARIA POLLENActive
Quantity: 0.00008 g in 1 mL
Code: 07A108ZKW5
Classification: ACTIB
CHENOPODIUM ALBUM POLLENActive
Quantity: 0.0004 g in 1 mL
Code: 098LKX5NCN
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT