APPLE
Allergenic Extracts
Approved
Approval ID
c1114779-3e11-47ab-8889-f534406f4041
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 11, 2011
Manufacturers
FDA
Allergy Laboratories, Inc.
DUNS: 007191810
Products 10
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
aspergillus fumigatus and botrytis cinerea and chaetomium globosum and epicoccum nigrum and fusarium oxysporum vasinfectum and cochliobolus sativus and neurospora sitophila and mucor plumbeus and phoma exigua var. exigua and penicillium chrysogenum var. chrysogenum and aureobasidium pullulans var. pullutans and rhizopus stolonifer and rhodotorula mucilaginosa and saccharomyces cerevisiae and geotrichum candidum
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54575-228
Application NumberBLA101376
Product Classification
M
Marketing Category
C73585
G
Generic Name
aspergillus fumigatus and botrytis cinerea and chaetomium globosum and epicoccum nigrum and fusarium oxysporum vasinfectum and cochliobolus sativus and neurospora sitophila and mucor plumbeus and phoma exigua var. exigua and penicillium chrysogenum var. chrysogenum and aureobasidium pullulans var. pullutans and rhizopus stolonifer and rhodotorula mucilaginosa and saccharomyces cerevisiae and geotrichum candidum
Product Specifications
Route of AdministrationPERCUTANEOUS, SUBCUTANEOUS
Effective DateMarch 15, 2011
FDA Product Classification
INGREDIENTS (19)
ASPERGILLUS FUMIGATUSActive
Quantity: 0.066 g in 20 mL
Code: X88DF51T48
Classification: ACTIB
BOTRYTIS CINEREAActive
Quantity: 0.066 g in 20 mL
Code: TBW53313S7
Classification: ACTIB
CHAETOMIUM GLOBOSUMActive
Quantity: 0.066 g in 20 mL
Code: 5016WB8B8A
Classification: ACTIB
EPICOCCUM NIGRUMActive
Quantity: 0.066 g in 20 mL
Code: 87U156LEN7
Classification: ACTIB
PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUMActive
Quantity: 0.067 g in 20 mL
Code: 3Y1PE1GCIG
Classification: ACTIB
FUSARIUM OXYSPORUM VASINFECTUMActive
Quantity: 0.066 g in 20 mL
Code: 6M98DC08TZ
Classification: ACTIB
NEUROSPORA SITOPHILAActive
Quantity: 0.067 g in 20 mL
Code: I9D9Z5GCW5
Classification: ACTIB
AUREOBASIDIUM PULLULANS VAR. PULLUTANSActive
Quantity: 0.067 g in 20 mL
Code: D1A2NG69CK
Classification: ACTIB
RHIZOPUS STOLONIFERActive
Quantity: 0.067 g in 20 mL
Code: FEE198DK4Q
Classification: ACTIB
RHODOTORULA MUCILAGINOSAActive
Quantity: 0.067 g in 20 mL
Code: 62TY3X4N9Z
Classification: ACTIB
SODIUM BICARBONATEInactive
Quantity: 0.091 g in 100 mL
Code: 8MDF5V39QO
Classification: IACT
COCHLIOBOLUS SATIVUSActive
Quantity: 0.067 g in 20 mL
Code: 3LN5B70U4W
Classification: ACTIB
MUCOR PLUMBEUSActive
Quantity: 0.067 g in 20 mL
Code: D7401PWY6E
Classification: ACTIB
PHOMA EXIGUA VAR. EXIGUAActive
Quantity: 0.067 g in 20 mL
Code: 8JAG41IE4M
Classification: ACTIB
SACCHAROMYCES CEREVISIAEActive
Quantity: 0.067 g in 20 mL
Code: 978D8U419H
Classification: ACTIB
GEOTRICHUM CANDIDUMActive
Quantity: 0.067 g in 20 mL
Code: 5964J742O8
Classification: ACTIB
SODIUM CHLORIDEInactive
Quantity: 0.166 g in 100 mL
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
GLYCERINInactive
Quantity: 50 mL in 100 mL
Code: PDC6A3C0OX
Classification: IACT
absidia capillata and acrothecium robustum and microsporum audouinii and microsporum canis and apiospora montagnei and phycomyces blakesleeanus and sporotrichum pruinosum and stachybotrys chartarum and syncephalastrum racemosum and tetracoccosporium paxianum and verticillium albo-atrum and thermomyces lanuginosus and trichosporon cutaneum
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54575-230
Application NumberBLA101376
Product Classification
M
Marketing Category
C73585
G
Generic Name
absidia capillata and acrothecium robustum and microsporum audouinii and microsporum canis and apiospora montagnei and phycomyces blakesleeanus and sporotrichum pruinosum and stachybotrys chartarum and syncephalastrum racemosum and tetracoccosporium paxianum and verticillium albo-atrum and thermomyces lanuginosus and trichosporon cutaneum
Product Specifications
Route of AdministrationPERCUTANEOUS, SUBCUTANEOUS
Effective DateMarch 15, 2011
FDA Product Classification
INGREDIENTS (17)
APIOSPORA MONTAGNEIActive
Quantity: 0.077 g in 20 mL
Code: 49VI1ZSO06
Classification: ACTIB
MICROSPORUM CANISActive
Quantity: 0.077 g in 20 mL
Code: N4F4RQ7BY7
Classification: ACTIB
Absidia capillataActive
Quantity: 0.076 g in 20 mL
Code: 15VX0351MT
Classification: ACTIB
ACROTHECIUM ROBUSTUMActive
Quantity: 0.077 g in 20 mL
Code: C91ZMT66YA
Classification: ACTIB
MICROSPORUM AUDOUINIIActive
Quantity: 0.077 g in 20 mL
Code: B7B86Y84R8
Classification: ACTIB
SPOROTRICHUM PRUINOSUMActive
Quantity: 0.077 g in 20 mL
Code: H20KU95UBG
Classification: ACTIB
SYNCEPHALASTRUM RACEMOSUMActive
Quantity: 0.077 g in 20 mL
Code: 2VWV12V9WR
Classification: ACTIB
SODIUM CHLORIDEInactive
Quantity: 0.166 g in 100 mL
Code: 451W47IQ8X
Classification: IACT
PHYCOMYCES BLAKESLEEANUSActive
Quantity: 0.077 g in 20 mL
Code: 41Y752Y34M
Classification: ACTIB
TETRACOCCOSPORIUM PAXIANUMActive
Quantity: 0.077 g in 20 mL
Code: KSY1AWN59I
Classification: ACTIB
VERTICILLIUM ALBO-ATRUMActive
Quantity: 0.077 g in 20 mL
Code: X92O101CS2
Classification: ACTIB
STACHYBOTRYS CHARTARUMActive
Quantity: 0.077 g in 20 mL
Code: HJ4L70T1ZP
Classification: ACTIB
THERMOMYCES LANUGINOSUSActive
Quantity: 0.077 g in 20 mL
Code: YI3WT83KTW
Classification: ACTIB
Trichosporon cutaneumActive
Quantity: 0.077 g in 20 mL
Code: 5EUI19VT92
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM BICARBONATEInactive
Quantity: 0.091 g in 100 mL
Code: 8MDF5V39QO
Classification: IACT
GLYCERINInactive
Quantity: 50 mL in 100 mL
Code: PDC6A3C0OX
Classification: IACT
trichothecium roseum and passalora fulva and cochliobolus spicifer and myrothecium verrucaria and trichophyton schoenleinii and mycogone nigra and neurospora crassa and khuskia oryzae and paecilomyces variotii and microascus brevicaulis and helminthosporium solani and pleospora tarda and streptomyces griseus and trichoderma viride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54575-229
Application NumberBLA101376
Product Classification
M
Marketing Category
C73585
G
Generic Name
trichothecium roseum and passalora fulva and cochliobolus spicifer and myrothecium verrucaria and trichophyton schoenleinii and mycogone nigra and neurospora crassa and khuskia oryzae and paecilomyces variotii and microascus brevicaulis and helminthosporium solani and pleospora tarda and streptomyces griseus and trichoderma viride
Product Specifications
Route of AdministrationPERCUTANEOUS, SUBCUTANEOUS
Effective DateMarch 15, 2011
FDA Product Classification
INGREDIENTS (18)
TRICHOTHECIUM ROSEUMActive
Quantity: 0.071 g in 20 mL
Code: TGO054E31O
Classification: ACTIB
PASSALORA FULVAActive
Quantity: 0.071 g in 20 mL
Code: HR6H5057CO
Classification: ACTIB
COCHLIOBOLUS SPICIFERActive
Quantity: 0.071 g in 20 mL
Code: 91M9RWP3TD
Classification: ACTIB
MYROTHECIUM VERRUCARIAActive
Quantity: 0.071 g in 20 mL
Code: W5U19AK212
Classification: ACTIB
TRICHOPHYTON SCHOENLEINIIActive
Quantity: 0.071 g in 20 mL
Code: Z4MD1809H1
Classification: ACTIB
Mycogone nigraActive
Quantity: 0.071 g in 20 mL
Code: 0X3XUJ41IX
Classification: ACTIB
NEUROSPORA CRASSAActive
Quantity: 0.071 g in 20 mL
Code: 1X92VM01YP
Classification: ACTIB
KHUSKIA ORYZAEActive
Quantity: 0.071 g in 20 mL
Code: VK8C112WTS
Classification: ACTIB
PAECILOMYCES VARIOTIIActive
Quantity: 0.072 g in 20 mL
Code: KO7V58BY40
Classification: ACTIB
MICROASCUS BREVICAULISActive
Quantity: 0.072 g in 20 mL
Code: DHI513VXU7
Classification: ACTIB
HELMINTHOSPORIUM SOLANIActive
Quantity: 0.072 g in 20 mL
Code: U6Z259H815
Classification: ACTIB
PLEOSPORA TARDAActive
Quantity: 0.072 g in 20 mL
Code: TPL549N9R8
Classification: ACTIB
STREPTOMYCES GRISEUSActive
Quantity: 0.072 g in 20 mL
Code: G0O5980Z7W
Classification: ACTIB
TRICHODERMA VIRIDEActive
Quantity: 0.072 g in 20 mL
Code: T8678F0P0Q
Classification: ACTIB
SODIUM CHLORIDEInactive
Quantity: 0.166 g in 100 mL
Code: 451W47IQ8X
Classification: IACT
SODIUM BICARBONATEInactive
Quantity: 0.091 g in 100 mL
Code: 8MDF5V39QO
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
GLYCERINInactive
Quantity: 50 mL in 100 mL
Code: PDC6A3C0OX
Classification: IACT
solenopsis invicta
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54575-315
Application NumberBLA101376
Product Classification
M
Marketing Category
C73585
G
Generic Name
solenopsis invicta
Product Specifications
Route of AdministrationPERCUTANEOUS, SUBCUTANEOUS
Effective DateMarch 15, 2011
FDA Product Classification
INGREDIENTS (5)
SOLENOPSIS INVICTAActive
Quantity: 1 g in 20 mL
Code: 5O7CR4P444
Classification: ACTIB
SODIUM CHLORIDEInactive
Quantity: 0.166 g in 100 mL
Code: 451W47IQ8X
Classification: IACT
SODIUM BICARBONATEInactive
Quantity: 0.091 g in 100 mL
Code: 8MDF5V39QO
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
GLYCERINInactive
Quantity: 50 mL in 100 mL
Code: PDC6A3C0OX
Classification: IACT
aedes taeniorhynchus
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54575-324
Application NumberBLA101376
Product Classification
M
Marketing Category
C73585
G
Generic Name
aedes taeniorhynchus
Product Specifications
Route of AdministrationPERCUTANEOUS, SUBCUTANEOUS
Effective DateMarch 15, 2011
FDA Product Classification
INGREDIENTS (5)
AEDES TAENIORHYNCHUSActive
Quantity: 1 g in 20 mL
Code: BN2DNW66IQ
Classification: ACTIB
SODIUM CHLORIDEInactive
Quantity: 0.166 g in 100 mL
Code: 451W47IQ8X
Classification: IACT
SODIUM BICARBONATEInactive
Quantity: 0.091 g in 100 mL
Code: 8MDF5V39QO
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
GLYCERINInactive
Quantity: 50 mL in 100 mL
Code: PDC6A3C0OX
Classification: IACT
periplaneta americana
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54575-318
Application NumberBLA101376
Product Classification
M
Marketing Category
C73585
G
Generic Name
periplaneta americana
Product Specifications
Route of AdministrationPERCUTANEOUS, SUBCUTANEOUS
Effective DateMarch 15, 2011
FDA Product Classification
INGREDIENTS (5)
PERIPLANETA AMERICANAActive
Quantity: 1 g in 20 mL
Code: 2RQ1L9N089
Classification: ACTIB
SODIUM CHLORIDEInactive
Quantity: 0.166 g in 100 mL
Code: 451W47IQ8X
Classification: IACT
SODIUM BICARBONATEInactive
Quantity: 0.091 g in 100 mL
Code: 8MDF5V39QO
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
GLYCERINInactive
Quantity: 50 mL in 100 mL
Code: PDC6A3C0OX
Classification: IACT
tuna
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54575-468
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
tuna
Product Specifications
Route of AdministrationPERCUTANEOUS, SUBCUTANEOUS
Effective DateMarch 15, 2011
FDA Product Classification
INGREDIENTS (5)
TUNAActive
Quantity: 1 g in 20 mL
Code: V2T3IHT3E2
Classification: ACTIB
SODIUM CHLORIDEInactive
Quantity: 0.166 g in 100 mL
Code: 451W47IQ8X
Classification: IACT
SODIUM BICARBONATEInactive
Quantity: 0.091 g in 100 mL
Code: 8MDF5V39QO
Classification: IACT
GLYCERINInactive
Quantity: 50 mL in 100 mL
Code: PDC6A3C0OX
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
turkey
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54575-469
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
turkey
Product Specifications
Route of AdministrationPERCUTANEOUS, SUBCUTANEOUS
Effective DateMarch 15, 2011
FDA Product Classification
INGREDIENTS (5)
TURKEYActive
Quantity: 1 g in 20 mL
Code: 8E9NT44R8I
Classification: ACTIB
SODIUM CHLORIDEInactive
Quantity: 0.166 g in 100 mL
Code: 451W47IQ8X
Classification: IACT
SODIUM BICARBONATEInactive
Quantity: 0.091 g in 100 mL
Code: 8MDF5V39QO
Classification: IACT
GLYCERINInactive
Quantity: 50 mL in 100 mL
Code: PDC6A3C0OX
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
maclura pomifera pollen
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54575-958
Application NumberBLA101376
Product Classification
M
Marketing Category
C73585
G
Generic Name
maclura pomifera pollen
Product Specifications
Route of AdministrationPERCUTANEOUS, SUBCUTANEOUS
Effective DateMarch 15, 2011
FDA Product Classification
INGREDIENTS (5)
MACLURA POMIFERA POLLENActive
Quantity: 1 g in 20 mL
Code: 18JOK51CZH
Classification: ACTIB
SODIUM CHLORIDEInactive
Quantity: 0.166 g in 100 mL
Code: 451W47IQ8X
Classification: IACT
SODIUM BICARBONATEInactive
Quantity: 0.091 g in 100 mL
Code: 8MDF5V39QO
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
GLYCERINInactive
Quantity: 50 mL in 100 mL
Code: PDC6A3C0OX
Classification: IACT
blatella germanica
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54575-319
Application NumberBLA101376
Product Classification
M
Marketing Category
C73585
G
Generic Name
blatella germanica
Product Specifications
Route of AdministrationPERCUTANEOUS, SUBCUTANEOUS
Effective DateMarch 15, 2011
FDA Product Classification
INGREDIENTS (5)
BLATELLA GERMANICAActive
Quantity: 1 g in 20 mL
Code: G9O67I0A8Q
Classification: ACTIB
SODIUM BICARBONATEInactive
Quantity: 0.091 g in 100 mL
Code: 8MDF5V39QO
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
GLYCERINInactive
Quantity: 50 mL in 100 mL
Code: PDC6A3C0OX
Classification: IACT
SODIUM CHLORIDEInactive
Quantity: 0.166 g in 100 mL
Code: 451W47IQ8X
Classification: IACT