Treatment Set TS344558
ALLERGENIC EXTRACTSINDIVIDUAL TREATMENT VIAL
Approved
Approval ID
a2a38721-f395-4aeb-927b-35c959ce586e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 18, 2012
Manufacturers
FDA
Antigen Laboratories, Inc.
DUNS: 030705628
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Treatment Set TS344570
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code49288-0837
Application NumberBLA102223
Product Classification
M
Marketing Category
C73585
G
Generic Name
Treatment Set TS344570
Product Specifications
Route of AdministrationSUBCUTANEOUS, INTRADERMAL
Effective DateFebruary 3, 2011
FDA Product Classification
INGREDIENTS (14)
FELIS CATUS HAIRActive
Quantity: 400 [BAU] in 1 mL
Code: 1564HD0N96
Classification: ACTIB
DERMATOPHAGOIDES FARINAEActive
Quantity: 400 [AU] in 1 mL
Code: PR9U2YPF3Q
Classification: ACTIB
ALTERNARIA ALTERNATAActive
Quantity: 0.01 g in 1 mL
Code: 52B29REC7H
Classification: ACTIB
DERMATOPHAGOIDES PTERONYSSINUSActive
Quantity: 400 [AU] in 1 mL
Code: 57L1Z5378K
Classification: ACTIB
PASCOPYRUM SMITHII POLLENActive
Quantity: 0.01 g in 1 mL
Code: 6AU0ZD8T1O
Classification: ACTIB
FRAXINUS AMERICANA POLLENActive
Quantity: 0.01 g in 1 mL
Code: G684LX721Q
Classification: ACTIB
QUERCUS ALBA POLLENActive
Quantity: 0.01 g in 1 mL
Code: Z4Y9ZSV4KK
Classification: ACTIB
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
AMBROSIA ARTEMISIIFOLIA POLLENActive
Quantity: 4000 [AU] in 1 mL
Code: K20Y81ACO3
Classification: ACTIB
SORGHUM HALEPENSE POLLENActive
Quantity: 0.002 g in 1 mL
Code: 577VA5B4HP
Classification: ACTIB
Treatment Set TS344558
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code49288-0836
Application NumberBLA102223
Product Classification
M
Marketing Category
C73585
G
Generic Name
Treatment Set TS344558
Product Specifications
Route of AdministrationINTRADERMAL, SUBCUTANEOUS
Effective DateFebruary 3, 2011
FDA Product Classification
INGREDIENTS (15)
RHIZOPUS STOLONIFERActive
Quantity: 0.002 g in 1 mL
Code: FEE198DK4Q
Classification: ACTIB
FRAXINUS AMERICANA POLLENActive
Quantity: 0.005 g in 1 mL
Code: G684LX721Q
Classification: ACTIB
QUERCUS ALBA POLLENActive
Quantity: 0.005 g in 1 mL
Code: Z4Y9ZSV4KK
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
CLADOSPORIUM CLADOSPORIOIDESActive
Quantity: 0.00008 g in 1 mL
Code: 4ZWY20GTGO
Classification: ACTIB
ASPERGILLUS FUMIGATUSActive
Quantity: 0.00004 g in 1 mL
Code: X88DF51T48
Classification: ACTIB
COCHLIOBOLUS SATIVUSActive
Quantity: 0.005 g in 1 mL
Code: 3LN5B70U4W
Classification: ACTIB
AUREOBASIDIUM PULLULANS VAR. PULLUTANSActive
Quantity: 0.005 g in 1 mL
Code: D1A2NG69CK
Classification: ACTIB
FUSARIUM OXYSPORUMActive
Quantity: 0.005 g in 1 mL
Code: 5398RXP8KU
Classification: ACTIB
PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUMActive
Quantity: 0.002 g in 1 mL
Code: 3Y1PE1GCIG
Classification: ACTIB
PHOMA DESTRUCTIVAActive
Quantity: 0.005 g in 1 mL
Code: A17SE577FM
Classification: ACTIB