Arabic Gum
Allergenic Extract
Approved
Approval ID
6673dd1e-f02f-4fcc-9037-003e666041d9
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 10, 2009
Manufacturers
FDA
Nelco Laboratories, Inc.
DUNS: 054980867
Products 10
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Cat Flea
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code36987-1847
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
Cat Flea
Product Specifications
Route of AdministrationINTRADERMAL, SUBCUTANEOUS
Effective DateDecember 10, 2009
FDA Product Classification
INGREDIENTS (6)
CTENOCEPHALIDES FELISActive
Quantity: 0.01 g in 1 mL
Code: 5X9Y89ENI9
Classification: ACTIB
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
Tragacanth Gum
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code36987-1646
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
Tragacanth Gum
Product Specifications
Route of AdministrationINTRADERMAL, SUBCUTANEOUS
Effective DateDecember 10, 2009
FDA Product Classification
INGREDIENTS (5)
TRAGACANTHActive
Quantity: 0.005 g in 1 mL
Code: 2944357O2O
Classification: ACTIB
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Dog Flea
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code36987-1802
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
Dog Flea
Product Specifications
Route of AdministrationINTRADERMAL, SUBCUTANEOUS
Effective DateDecember 10, 2009
FDA Product Classification
INGREDIENTS (5)
CTENOCEPHALIDES CANISActive
Quantity: 0.01 g in 1 mL
Code: LN7IM9RDEA
Classification: ACTIB
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Dog Flea
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code36987-1803
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
Dog Flea
Product Specifications
Route of AdministrationINTRADERMAL, SUBCUTANEOUS
Effective DateDecember 10, 2009
FDA Product Classification
INGREDIENTS (6)
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
CTENOCEPHALIDES CANISActive
Quantity: 0.01 g in 1 mL
Code: LN7IM9RDEA
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Karaya Gum
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code36987-1642
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
Karaya Gum
Product Specifications
Route of AdministrationINTRADERMAL, SUBCUTANEOUS
Effective DateDecember 10, 2009
FDA Product Classification
INGREDIENTS (5)
KARAYA GUMActive
Quantity: 0.005 g in 1 mL
Code: 73W9IQY50Q
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
Karaya Gum
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code36987-1644
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
Karaya Gum
Product Specifications
Route of AdministrationINTRADERMAL, SUBCUTANEOUS
Effective DateDecember 10, 2009
FDA Product Classification
INGREDIENTS (5)
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
KARAYA GUMActive
Quantity: 0.01 g in 1 mL
Code: 73W9IQY50Q
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
Arabic Gum
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code36987-1638
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
Arabic Gum
Product Specifications
Route of AdministrationINTRADERMAL, SUBCUTANEOUS
Effective DateDecember 10, 2009
FDA Product Classification
INGREDIENTS (5)
ACACIAActive
Quantity: 0.005 g in 1 mL
Code: 5C5403N26O
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
Cat Flea
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code36987-1846
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
Cat Flea
Product Specifications
Route of AdministrationINTRADERMAL, SUBCUTANEOUS
Effective DateDecember 10, 2009
FDA Product Classification
INGREDIENTS (5)
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
CTENOCEPHALIDES FELISActive
Quantity: 0.01 g in 1 mL
Code: 5X9Y89ENI9
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
Arabic Gum
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code36987-1640
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
Arabic Gum
Product Specifications
Route of AdministrationINTRADERMAL, SUBCUTANEOUS
Effective DateDecember 10, 2009
FDA Product Classification
INGREDIENTS (5)
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
ACACIAActive
Quantity: 0.01 g in 1 mL
Code: 5C5403N26O
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
Tragacanth Gum
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code36987-1648
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
Tragacanth Gum
Product Specifications
Route of AdministrationINTRADERMAL, SUBCUTANEOUS
Effective DateDecember 10, 2009
FDA Product Classification
INGREDIENTS (5)
TRAGACANTHActive
Quantity: 0.01 g in 1 mL
Code: 2944357O2O
Classification: ACTIB
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT