Flaxseed
Allergenic Extract
Approved
Approval ID
8f238b35-8555-43af-b14a-2ba46444bf5a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 11, 2009
Manufacturers
FDA
Nelco Laboratories, Inc.
DUNS: 054980867
Products 4
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Sisal
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code36987-2256
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
Sisal
Product Specifications
Route of AdministrationINTRADERMAL, SUBCUTANEOUS
Effective DateDecember 11, 2009
FDA Product Classification
INGREDIENTS (5)
AGAVE SISALANA FIBERActive
Quantity: 20000 [PNU] in 1 mL
Code: MRJ91HVV4H
Classification: ACTIB
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
Jute
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code36987-2248
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
Jute
Product Specifications
Route of AdministrationINTRADERMAL, SUBCUTANEOUS
Effective DateDecember 11, 2009
FDA Product Classification
INGREDIENTS (5)
CORCORUS CAPSULARIS FIBERActive
Quantity: 20000 [PNU] in 1 mL
Code: TVA75O7S63
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
Flaxseed
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code36987-2216
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
Flaxseed
Product Specifications
Route of AdministrationINTRADERMAL, SUBCUTANEOUS
Effective DateDecember 11, 2009
FDA Product Classification
INGREDIENTS (5)
FLAX SEEDActive
Quantity: 20000 [PNU] in 1 mL
Code: 4110YT348C
Classification: ACTIB
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
Tobacco Leaf
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code36987-2240
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
Tobacco Leaf
Product Specifications
Route of AdministrationINTRADERMAL, SUBCUTANEOUS
Effective DateDecember 11, 2009
FDA Product Classification
INGREDIENTS (5)
TOBACCO LEAFActive
Quantity: 20000 [PNU] in 1 mL
Code: 6YR2608RSU
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT