Dandelion
Allergenic Extract
Approved
Approval ID
98bdde2e-6f04-4ff4-a6e3-1348d31c1bb1
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 4, 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.
Common Sagebrush
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code36987-3405
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
Common Sagebrush
Product Specifications
Route of AdministrationSUBCUTANEOUS, INTRADERMAL
Effective DateDecember 4, 2009
FDA Product Classification
INGREDIENTS (5)
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
ARTEMISIA TRIDENTATA POLLENActive
Quantity: 10000 [PNU] in 1 mL
Code: YI19RB8YFD
Classification: ACTIB
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
Russian Thistle
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code36987-3397
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
Russian Thistle
Product Specifications
Route of AdministrationSUBCUTANEOUS, INTRADERMAL
Effective DateDecember 4, 2009
FDA Product Classification
INGREDIENTS (5)
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SALSOLA KALI POLLENActive
Quantity: 10000 [PNU] in 1 mL
Code: 2MH135KC6G
Classification: ACTIB
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Saltbush
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code36987-3413
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
Saltbush
Product Specifications
Route of AdministrationSUBCUTANEOUS, INTRADERMAL
Effective DateDecember 4, 2009
FDA Product Classification
INGREDIENTS (5)
ATRIPLEX WRIGHTII POLLENActive
Quantity: 10000 [PNU] in 1 mL
Code: YB1308W43O
Classification: ACTIB
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
Sheep Sorrel
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code36987-3421
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
Sheep Sorrel
Product Specifications
Route of AdministrationSUBCUTANEOUS, INTRADERMAL
Effective DateDecember 4, 2009
FDA Product Classification
INGREDIENTS (5)
RUMEX ACETOSELLA POLLENActive
Quantity: 10000 [PNU] in 1 mL
Code: N52MIQ81ZW
Classification: ACTIB
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Wormwook
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code36987-3445
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
Wormwook
Product Specifications
Route of AdministrationSUBCUTANEOUS, INTRADERMAL
Effective DateDecember 4, 2009
FDA Product Classification
INGREDIENTS (5)
ARTEMISIA ABSINTHIUM POLLENActive
Quantity: 10000 [PNU] in 1 mL
Code: 81GS97HVFO
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
Tall Ragweed
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code36987-3389
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
Tall Ragweed
Product Specifications
Route of AdministrationSUBCUTANEOUS, INTRADERMAL
Effective DateDecember 4, 2009
FDA Product Classification
INGREDIENTS (5)
AMBROSIA TRIFIDA POLLENActive
Quantity: 10000 [PNU] in 1 mL
Code: KU1V1898XX
Classification: ACTIB
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
Curly Dock
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code36987-3181
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
Curly Dock
Product Specifications
Route of AdministrationINTRADERMAL, SUBCUTANEOUS
Effective DateDecember 4, 2009
FDA Product Classification
INGREDIENTS (5)
RUMEX CRISPUS POLLENActive
Quantity: 10000 [PNU] in 1 mL
Code: V825XJG64G
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
Western Ragweed
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code36987-3429
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
Western Ragweed
Product Specifications
Route of AdministrationSUBCUTANEOUS, INTRADERMAL
Effective DateDecember 4, 2009
FDA Product Classification
INGREDIENTS (5)
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
AMBROSIA PSILOSTACHYA POLLENActive
Quantity: 10000 [PNU] in 1 mL
Code: RX18M46K8L
Classification: ACTIB
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
Wingscale
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code36987-3437
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
Wingscale
Product Specifications
Route of AdministrationSUBCUTANEOUS, INTRADERMAL
Effective DateDecember 4, 2009
FDA Product Classification
INGREDIENTS (5)
ATRIPLEX CANESCENS POLLENActive
Quantity: 10000 [PNU] in 1 mL
Code: 26U0BU8G83
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Carelessweed
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code36987-3157
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
Carelessweed
Product Specifications
Route of AdministrationINTRADERMAL, SUBCUTANEOUS
Effective DateDecember 4, 2009
FDA Product Classification
INGREDIENTS (5)
AMARANTHUS PALMERI POLLENActive
Quantity: 10000 [PNU] in 1 mL
Code: 1GH3WV23KH
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT