MedPath

Flaxseed

Allergenic Extract

Approved
Approval ID

fb086079-a3f1-458e-8910-2e72c7eae87c

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.

Tobacco Leaf

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code36987-2238
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)

SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
TOBACCO LEAFActive
Quantity: 10000 [PNU] in 1 mL
Code: 6YR2608RSU
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
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 Code36987-2214
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)

SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
FLAX SEEDActive
Quantity: 10000 [PNU] in 1 mL
Code: 4110YT348C
Classification: ACTIB

Jute

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code36987-2246
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)

SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
CORCORUS CAPSULARIS FIBERActive
Quantity: 10000 [PNU] in 1 mL
Code: TVA75O7S63
Classification: ACTIB
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT

Sisal

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code36987-2254
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: 10000 [PNU] in 1 mL
Code: MRJ91HVV4H
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT

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Flaxseed - FDA Drug Approval Details