MedPath

Carob

Allergenic Extract

Approved
Approval ID

addbb916-198c-4992-98c3-a66b19a1e241

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Nov 17, 2009

Manufacturers
FDA

Antigen Laboratories, Inc.

DUNS: 030705628

Products 5

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Carob

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code49288-0109
Application NumberBLA102223
Product Classification
M
Marketing Category
C73585
G
Generic Name
Carob
Product Specifications
Route of AdministrationSUBCUTANEOUS, INTRADERMAL
Effective DateNovember 17, 2009
FDA Product Classification

INGREDIENTS (5)

CAROBActive
Quantity: 0.05 g in 1 mL
Code: 5MG5Z946UO
Classification: ACTIB
SODIUM BICARBONATEInactive
Quantity: 0.0024 g in 1 mL
Code: 8MDF5V39QO
Classification: IACT
SODIUM CHLORIDEInactive
Quantity: 0.0095 g in 1 mL
Code: 451W47IQ8X
Classification: IACT
GLYCERINInactive
Quantity: 0.525 mL in 1 mL
Code: PDC6A3C0OX
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT

Tea

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code49288-0567
Application NumberBLA102223
Product Classification
M
Marketing Category
C73585
G
Generic Name
Tea
Product Specifications
Route of AdministrationINTRADERMAL, SUBCUTANEOUS
Effective DateNovember 17, 2009
FDA Product Classification

INGREDIENTS (5)

GLYCERINInactive
Quantity: 0.525 mL in 1 mL
Code: PDC6A3C0OX
Classification: IACT
TEA LEAFActive
Quantity: 0.05 g in 1 mL
Code: GH42T47V24
Classification: ACTIB
SODIUM CHLORIDEInactive
Quantity: 0.0095 g in 1 mL
Code: 451W47IQ8X
Classification: IACT
SODIUM BICARBONATEInactive
Quantity: 0.0024 g in 1 mL
Code: 8MDF5V39QO
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT

Cayenne Pepper

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code49288-0426
Application NumberBLA102223
Product Classification
M
Marketing Category
C73585
G
Generic Name
Cayenne Pepper
Product Specifications
Route of AdministrationSUBCUTANEOUS, INTRADERMAL
Effective DateNovember 17, 2009
FDA Product Classification

INGREDIENTS (5)

GLYCERINInactive
Quantity: 0.525 mL in 1 mL
Code: PDC6A3C0OX
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM CHLORIDEInactive
Quantity: 0.0095 g in 1 mL
Code: 451W47IQ8X
Classification: IACT
SODIUM BICARBONATEInactive
Quantity: 0.0024 g in 1 mL
Code: 8MDF5V39QO
Classification: IACT
CHILI PEPPERActive
Quantity: 0.05 g in 1 mL
Code: 00UK7646FG
Classification: ACTIB

Currant

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code49288-0151
Application NumberBLA102223
Product Classification
M
Marketing Category
C73585
G
Generic Name
Currant
Product Specifications
Route of AdministrationSUBCUTANEOUS, INTRADERMAL
Effective DateNovember 17, 2009
FDA Product Classification

INGREDIENTS (5)

RED CURRANTActive
Quantity: 0.05 g in 1 mL
Code: Q5YG47WU3D
Classification: ACTIB
GLYCERINInactive
Quantity: 0.525 mL in 1 mL
Code: PDC6A3C0OX
Classification: IACT
SODIUM CHLORIDEInactive
Quantity: 0.0095 g in 1 mL
Code: 451W47IQ8X
Classification: IACT
SODIUM BICARBONATEInactive
Quantity: 0.0024 g in 1 mL
Code: 8MDF5V39QO
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT

Sugar Cane

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code49288-0482
Application NumberBLA102223
Product Classification
M
Marketing Category
C73585
G
Generic Name
Sugar Cane
Product Specifications
Route of AdministrationSUBCUTANEOUS, INTRADERMAL
Effective DateNovember 17, 2009
FDA Product Classification

INGREDIENTS (5)

SUGARCANEActive
Quantity: 0.05 g in 1 mL
Code: 81H2R5AOH3
Classification: ACTIB
GLYCERINInactive
Quantity: 0.525 mL in 1 mL
Code: PDC6A3C0OX
Classification: IACT
SODIUM CHLORIDEInactive
Quantity: 0.0095 g in 1 mL
Code: 451W47IQ8X
Classification: IACT
SODIUM BICARBONATEInactive
Quantity: 0.0024 g in 1 mL
Code: 8MDF5V39QO
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT

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Carob - FDA Drug Approval Details