Cotton Linters
Allergenic Extract
Approved
Approval ID
d71013ab-718c-4cb0-ae1a-31fdd6db8851
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 13, 2009
Manufacturers
FDA
Antigen Laboratories, Inc.
DUNS: 030705628
Products 9
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Cotton Linters
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code49288-0154
Application NumberBLA102223
Product Classification
M
Marketing Category
C73585
G
Generic Name
Cotton Linters
Product Specifications
Route of AdministrationSUBCUTANEOUS, INTRADERMAL
Effective DateNovember 13, 2009
FDA Product Classification
INGREDIENTS (5)
SODIUM CHLORIDEInactive
Quantity: 0.0095 g in 1 mL
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
COTTON FIBERActive
Quantity: 0.05 g in 1 mL
Code: 70LDW53ROO
Classification: ACTIB
SODIUM BICARBONATEInactive
Quantity: 0.0024 g in 1 mL
Code: 8MDF5V39QO
Classification: IACT
GLYCERINInactive
Quantity: 0.525 mL in 1 mL
Code: PDC6A3C0OX
Classification: IACT
Kapok
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code49288-0285
Application NumberBLA102223
Product Classification
M
Marketing Category
C73585
G
Generic Name
Kapok
Product Specifications
Route of AdministrationSUBCUTANEOUS, INTRADERMAL
Effective DateNovember 13, 2009
FDA Product Classification
INGREDIENTS (5)
CEIBA PENTANDRA FIBERActive
Quantity: 0.05 g in 1 mL
Code: 758Z9H9WV9
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
Leaf Tobacco
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code49288-0581
Application NumberBLA102223
Product Classification
M
Marketing Category
C73585
G
Generic Name
Leaf Tobacco
Product Specifications
Route of AdministrationSUBCUTANEOUS, INTRADERMAL
Effective DateNovember 13, 2009
FDA Product Classification
INGREDIENTS (5)
GLYCERINInactive
Quantity: 0.525 mL in 1 mL
Code: PDC6A3C0OX
Classification: IACT
SODIUM BICARBONATEInactive
Quantity: 0.0024 g in 1 mL
Code: 8MDF5V39QO
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM CHLORIDEInactive
Quantity: 0.0095 g in 1 mL
Code: 451W47IQ8X
Classification: IACT
TOBACCO LEAFActive
Quantity: 0.1 g in 1 mL
Code: 6YR2608RSU
Classification: ACTIB
Leaf Tobacco
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code49288-0582
Application NumberBLA102223
Product Classification
M
Marketing Category
C73585
G
Generic Name
Leaf Tobacco
Product Specifications
Route of AdministrationSUBCUTANEOUS, INTRADERMAL
Effective DateNovember 13, 2009
FDA Product Classification
INGREDIENTS (5)
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
WATERInactive
Code: 059QF0KO0R
Classification: IACT
TOBACCO LEAFActive
Quantity: 0.05 g in 1 mL
Code: 6YR2608RSU
Classification: ACTIB
SODIUM BICARBONATEInactive
Quantity: 0.0024 g in 1 mL
Code: 8MDF5V39QO
Classification: IACT
Leaf Tobacco
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code49288-0583
Application NumberBLA102223
Product Classification
M
Marketing Category
C73585
G
Generic Name
Leaf Tobacco
Product Specifications
Route of AdministrationSUBCUTANEOUS, INTRADERMAL
Effective DateNovember 13, 2009
FDA Product Classification
INGREDIENTS (5)
TOBACCO LEAFActive
Quantity: 0.02 g in 1 mL
Code: 6YR2608RSU
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
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM BICARBONATEInactive
Quantity: 0.0024 g in 1 mL
Code: 8MDF5V39QO
Classification: IACT
Orris Root
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code49288-0343
Application NumberBLA102223
Product Classification
M
Marketing Category
C73585
G
Generic Name
Orris Root
Product Specifications
Route of AdministrationSUBCUTANEOUS, INTRADERMAL
Effective DateNovember 13, 2009
FDA Product Classification
INGREDIENTS (5)
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
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM BICARBONATEInactive
Quantity: 0.0024 g in 1 mL
Code: 8MDF5V39QO
Classification: IACT
IRIS GERMANICA VAR. FLORENTINA ROOTActive
Quantity: 0.1 g in 1 mL
Code: M30XO5X4XD
Classification: ACTIB
Orris Root
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code49288-0344
Application NumberBLA102223
Product Classification
M
Marketing Category
C73585
G
Generic Name
Orris Root
Product Specifications
Route of AdministrationSUBCUTANEOUS, INTRADERMAL
Effective DateNovember 13, 2009
FDA Product Classification
INGREDIENTS (5)
IRIS GERMANICA VAR. FLORENTINA ROOTActive
Quantity: 0.05 g in 1 mL
Code: M30XO5X4XD
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM BICARBONATEInactive
Quantity: 0.0024 g in 1 mL
Code: 8MDF5V39QO
Classification: IACT
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
Pyrethrum
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code49288-0403
Application NumberBLA102223
Product Classification
M
Marketing Category
C73585
G
Generic Name
Pyrethrum
Product Specifications
Route of AdministrationSUBCUTANEOUS, INTRADERMAL
Effective DateNovember 13, 2009
FDA Product Classification
INGREDIENTS (5)
PYRETHRUM CINERARIIFOLIUMActive
Quantity: 0.05 g in 1 mL
Code: CGF76TP7X6
Classification: ACTIB
GLYCERINInactive
Quantity: 0.525 mL in 1 mL
Code: PDC6A3C0OX
Classification: IACT
SODIUM BICARBONATEInactive
Quantity: 0.0024 g in 1 mL
Code: 8MDF5V39QO
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM CHLORIDEInactive
Quantity: 0.0095 g in 1 mL
Code: 451W47IQ8X
Classification: IACT
Jute
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code49288-0272
Application NumberBLA102223
Product Classification
M
Marketing Category
C73585
G
Generic Name
Jute
Product Specifications
Route of AdministrationSUBCUTANEOUS, INTRADERMAL
Effective DateNovember 13, 2009
FDA Product Classification
INGREDIENTS (5)
SODIUM CHLORIDEInactive
Quantity: 0.0095 g in 1 mL
Code: 451W47IQ8X
Classification: IACT
CORCORUS CAPSULARIS FIBERActive
Quantity: 0.05 g in 1 mL
Code: TVA75O7S63
Classification: ACTIB
GLYCERINInactive
Quantity: 0.525 mL in 1 mL
Code: PDC6A3C0OX
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM BICARBONATEInactive
Quantity: 0.0024 g in 1 mL
Code: 8MDF5V39QO
Classification: IACT