Treatment Set TS336667
ALLERGENIC EXTRACTSINDIVIDUAL TREATMENT VIAL
Approved
Approval ID
400bff34-d1a7-420e-9635-3119313cea5e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 12, 2010
Manufacturers
FDA
Antigen Laboratories, Inc.
DUNS: 030705628
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Treatment Set TS336683
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code49288-0789
Application NumberBLA102223
Product Classification
M
Marketing Category
C73585
G
Generic Name
Treatment Set TS336683
Product Specifications
Route of AdministrationSUBCUTANEOUS, INTRADERMAL
Effective DateJuly 12, 2010
FDA Product Classification
INGREDIENTS (20)
BETULA POPULIFOLIA POLLENActive
Quantity: 0.000016 g in 1 mL
Code: 23H70FYJ5U
Classification: ACTIB
ULMUS AMERICANA POLLENActive
Quantity: 0.0004 g in 1 mL
Code: 89BAT511BD
Classification: ACTIB
ACER RUBRUM POLLENActive
Quantity: 0.0004 g in 1 mL
Code: 700NK45C76
Classification: ACTIB
QUERCUS ALBA POLLENActive
Quantity: 0.0004 g in 1 mL
Code: Z4Y9ZSV4KK
Classification: ACTIB
POPULUS DELTOIDES POLLENActive
Quantity: 0.00008 g in 1 mL
Code: 476DVV63WP
Classification: ACTIB
JUNIPERUS VIRGINIANA POLLENActive
Quantity: 0.00008 g in 1 mL
Code: PY0JA16R2G
Classification: ACTIB
CARYA ILLINOINENSIS POLLENActive
Quantity: 0.000016 g in 1 mL
Code: PYO4JR720Y
Classification: ACTIB
FRAXINUS AMERICANA POLLENActive
Quantity: 0.0004 g in 1 mL
Code: G684LX721Q
Classification: ACTIB
AMBROSIA ARTEMISIIFOLIA POLLENActive
Quantity: 20000 [AU] in 1 mL
Code: K20Y81ACO3
Classification: ACTIB
PLANTAGO LANCEOLATA POLLENActive
Quantity: 0.0004 g in 1 mL
Code: DO87T1U2CI
Classification: ACTIB
CHENOPODIUM ALBUM POLLENActive
Quantity: 0.002 g in 1 mL
Code: 098LKX5NCN
Classification: ACTIB
SALSOLA KALI POLLENActive
Quantity: 0.0004 g in 1 mL
Code: 2MH135KC6G
Classification: ACTIB
RUMEX ACETOSELLA POLLENActive
Quantity: 0.002 g in 1 mL
Code: N52MIQ81ZW
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
IVA ANNUA VAR. ANNUA POLLENActive
Quantity: 0.01 g in 1 mL
Code: Y2U5S5PF22
Classification: ACTIB
AMARANTHUS RETROFLEXUS POLLENActive
Quantity: 0.0004 g in 1 mL
Code: 73B14PX5FW
Classification: ACTIB
Treatment Set TS336667
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code49288-0787
Application NumberBLA102223
Product Classification
M
Marketing Category
C73585
G
Generic Name
Treatment Set TS336667
Product Specifications
Route of AdministrationSUBCUTANEOUS, INTRADERMAL
Effective DateJuly 12, 2010
FDA Product Classification
INGREDIENTS (9)
ALTERNARIA ALTERNATAActive
Quantity: 0.002 g in 1 mL
Code: 52B29REC7H
Classification: ACTIB
AMBROSIA ARTEMISIIFOLIA POLLENActive
Quantity: 4000 [AU] in 1 mL
Code: K20Y81ACO3
Classification: ACTIB
FELIS CATUS HAIRActive
Quantity: 400 [BAU] in 1 mL
Code: 1564HD0N96
Classification: ACTIB
CANIS LUPUS FAMILIARIS HAIRActive
Quantity: 0.002 g in 1 mL
Code: 05S7L91ZTR
Classification: ACTIB
PHLEUM PRATENSE POLLENActive
Quantity: 4000 [BAU] in 1 mL
Code: 65M88RW2EG
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
Treatment Set TS336682
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code49288-0788
Application NumberBLA102223
Product Classification
M
Marketing Category
C73585
G
Generic Name
Treatment Set TS336682
Product Specifications
Route of AdministrationSUBCUTANEOUS, INTRADERMAL
Effective DateJuly 12, 2010
FDA Product Classification
INGREDIENTS (17)
FELIS CATUS HAIRActive
Quantity: 400 [BAU] in 1 mL
Code: 1564HD0N96
Classification: ACTIB
CANIS LUPUS FAMILIARIS HAIRActive
Quantity: 0.005 g in 1 mL
Code: 05S7L91ZTR
Classification: ACTIB
CYNODON DACTYLON POLLENActive
Quantity: 80 [BAU] in 1 mL
Code: 175F461W10
Classification: ACTIB
SORGHUM HALEPENSE POLLENActive
Quantity: 0.0004 g in 1 mL
Code: 577VA5B4HP
Classification: ACTIB
POA PRATENSIS POLLENActive
Quantity: 800 [BAU] in 1 mL
Code: SCB8J7LS3T
Classification: ACTIB
PASPALUM NOTATUM POLLENActive
Quantity: 0.0004 g in 1 mL
Code: V003SHB7VK
Classification: ACTIB
DERMATOPHAGOIDES FARINAEActive
Quantity: 1000 [AU] in 1 mL
Code: PR9U2YPF3Q
Classification: ACTIB
DERMATOPHAGOIDES PTERONYSSINUSActive
Quantity: 1000 [AU] in 1 mL
Code: 57L1Z5378K
Classification: ACTIB
RHIZOPUS STOLONIFERActive
Quantity: 0.005 g in 1 mL
Code: FEE198DK4Q
Classification: ACTIB
DACTYLIS GLOMERATA POLLENActive
Quantity: 4000 [BAU] in 1 mL
Code: 83N78IDA7P
Classification: ACTIB
LOLIUM PERENNE POLLENActive
Quantity: 160 [BAU] in 1 mL
Code: 4T81LB52R0
Classification: ACTIB
PHLEUM PRATENSE POLLENActive
Quantity: 800 [BAU] in 1 mL
Code: 65M88RW2EG
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT