Red Delicious Apple
Allergenic Extract
Approved
Approval ID
b65366b5-55ea-49dc-8011-8ef9af097291
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 9, 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.
Black Pepper
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code36987-1766
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
Black Pepper
Product Specifications
Route of AdministrationINTRADERMAL, SUBCUTANEOUS
Effective DateDecember 9, 2009
FDA Product Classification
INGREDIENTS (5)
BLACK PEPPERActive
Quantity: 0.05 g in 1 mL
Code: KM66971LVF
Classification: ACTIB
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Orange Pekoe Tea
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code36987-1654
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
Orange Pekoe Tea
Product Specifications
Route of AdministrationINTRADERMAL, SUBCUTANEOUS
Effective DateDecember 9, 2009
FDA Product Classification
INGREDIENTS (5)
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
TEA LEAFActive
Quantity: 0.05 g in 1 mL
Code: GH42T47V24
Classification: ACTIB
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Hops
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code36987-1774
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
Hops
Product Specifications
Route of AdministrationINTRADERMAL, SUBCUTANEOUS
Effective DateDecember 9, 2009
FDA Product Classification
INGREDIENTS (5)
HOPSActive
Quantity: 0.05 g in 1 mL
Code: 01G73H6H83
Classification: ACTIB
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Poppyseed
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code36987-1730
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
Poppyseed
Product Specifications
Route of AdministrationINTRADERMAL, SUBCUTANEOUS
Effective DateDecember 9, 2009
FDA Product Classification
INGREDIENTS (5)
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
POPPY SEEDActive
Quantity: 0.05 g in 1 mL
Code: 60RO23IR87
Classification: ACTIB
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
Sage
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code36987-1734
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
Sage
Product Specifications
Route of AdministrationINTRADERMAL, SUBCUTANEOUS
Effective DateDecember 9, 2009
FDA Product Classification
INGREDIENTS (5)
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
SALVIA OFFICINALISActive
Quantity: 0.05 g in 1 mL
Code: 065C5D077J
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
White Kidney Beans
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code36987-1758
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
White Kidney Beans
Product Specifications
Route of AdministrationINTRADERMAL, SUBCUTANEOUS
Effective DateDecember 9, 2009
FDA Product Classification
INGREDIENTS (5)
KIDNEY BEANActive
Quantity: 0.05 g in 1 mL
Code: M98C8416QO
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Sesame
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code36987-1738
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
Sesame
Product Specifications
Route of AdministrationINTRADERMAL, SUBCUTANEOUS
Effective DateDecember 9, 2009
FDA Product Classification
INGREDIENTS (5)
SESAME SEEDActive
Quantity: 0.05 g in 1 mL
Code: 7Y1255HVXR
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Nutmeg
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code36987-1710
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
Nutmeg
Product Specifications
Route of AdministrationINTRADERMAL, SUBCUTANEOUS
Effective DateDecember 9, 2009
FDA Product Classification
INGREDIENTS (5)
NUTMEGActive
Quantity: 0.05 g in 1 mL
Code: AEE24M3MQ9
Classification: ACTIB
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Paprika
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code36987-1718
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
Paprika
Product Specifications
Route of AdministrationINTRADERMAL, SUBCUTANEOUS
Effective DateDecember 9, 2009
FDA Product Classification
INGREDIENTS (5)
PAPRIKAActive
Quantity: 0.05 g in 1 mL
Code: X72Z47861V
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Wheat Bran
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code36987-1754
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
Wheat Bran
Product Specifications
Route of AdministrationINTRADERMAL, SUBCUTANEOUS
Effective DateDecember 9, 2009
FDA Product Classification
INGREDIENTS (5)
WATERInactive
Code: 059QF0KO0R
Classification: IACT
WHEAT BRANActive
Quantity: 0.05 g in 1 mL
Code: 6L966A1IMR
Classification: ACTIB
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT