MedPath

Fire Ant

Allergenic Extract

Approved
Approval ID

470d7a58-b8ee-4f97-a5e2-3e8c65096231

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Dec 11, 2009

Manufacturers
FDA

Nelco Laboratories, Inc.

DUNS: 054980867

Products 6

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

German Cockroach

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code36987-1837
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
German Cockroach
Product Specifications
Route of AdministrationINTRADERMAL, SUBCUTANEOUS
Effective DateDecember 11, 2009
FDA Product Classification

INGREDIENTS (6)

SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
ALLERGENIC EXTRACT- COCKROACH, GERMAN BLATELLA GERMANICAActive
Quantity: 10000 [PNU] in 1 mL
Code: G9O67I0A8Q
Classification: ACTIB
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT

Fire Ant

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code36987-1779
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
Fire Ant
Product Specifications
Route of AdministrationINTRADERMAL, SUBCUTANEOUS
Effective DateDecember 11, 2009
FDA Product Classification

INGREDIENTS (6)

SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
SOLENOPSIS INVICTAActive
Quantity: 10000 [PNU] in 1 mL
Code: 5O7CR4P444
Classification: ACTIB
PHENOLInactive
Code: 339NCG44TV
Classification: IACT

Horse Fly

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code36987-1805
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
Horse Fly
Product Specifications
Route of AdministrationINTRADERMAL, SUBCUTANEOUS
Effective DateDecember 11, 2009
FDA Product Classification

INGREDIENTS (6)

MUSCA DOMESTICAActive
Quantity: 10000 [PNU] in 1 mL
Code: PV7823W303
Classification: ACTIB
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT

House Fly

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code36987-1787
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
House Fly
Product Specifications
Route of AdministrationINTRADERMAL, SUBCUTANEOUS
Effective DateDecember 11, 2009
FDA Product Classification

INGREDIENTS (6)

SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
MUSCA DOMESTICAActive
Quantity: 10000 [PNU] in 1 mL
Code: PV7823W303
Classification: ACTIB
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT

Mosquito

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code36987-1813
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
Mosquito
Product Specifications
Route of AdministrationINTRADERMAL, SUBCUTANEOUS
Effective DateDecember 11, 2009
FDA Product Classification

INGREDIENTS (6)

SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
AEDES TAENIORHYNCHUSActive
Quantity: 10000 [PNU] in 1 mL
Code: BN2DNW66IQ
Classification: ACTIB
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT

Cockroach American

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code36987-1795
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
Cockroach American
Product Specifications
Route of AdministrationINTRADERMAL, SUBCUTANEOUS
Effective DateDecember 11, 2009
FDA Product Classification

INGREDIENTS (6)

ALLERGENIC EXTRACT- COCKROACH PERIPLANETA AMERICANAActive
Quantity: 10000 [PNU] in 1 mL
Code: 2RQ1L9N089
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT

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