Casein
Allergenic Extract
Approved
Approval ID
c56e8962-24d2-4aad-8b1b-06f26fedd7ae
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 10, 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.
Casein
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code36987-1174
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
Casein
Product Specifications
Route of AdministrationINTRADERMAL, SUBCUTANEOUS
Effective DateDecember 10, 2009
FDA Product Classification
INGREDIENTS (5)
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
CASEINActive
Quantity: 0.05 g in 1 mL
Code: 48268V50D5
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
Goats Milk
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code36987-1184
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
Goats Milk
Product Specifications
Route of AdministrationINTRADERMAL, SUBCUTANEOUS
Effective DateDecember 10, 2009
FDA Product Classification
INGREDIENTS (5)
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
GOAT MILKActive
Quantity: 0.1 g in 1 mL
Code: XE5K5I4RP7
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
Goats Milk
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code36987-1185
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
Goats Milk
Product Specifications
Route of AdministrationINTRADERMAL, SUBCUTANEOUS
Effective DateDecember 10, 2009
FDA Product Classification
INGREDIENTS (6)
GOAT MILKActive
Quantity: 0.01 g in 1 mL
Code: XE5K5I4RP7
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
Goats Milk
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code36987-1183
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
Goats Milk
Product Specifications
Route of AdministrationINTRADERMAL, SUBCUTANEOUS
Effective DateDecember 10, 2009
FDA Product Classification
INGREDIENTS (6)
GOAT MILKActive
Quantity: 0.05 g in 1 mL
Code: XE5K5I4RP7
Classification: ACTIB
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
Cows Milk
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code36987-1181
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
Cows Milk
Product Specifications
Route of AdministrationINTRADERMAL, SUBCUTANEOUS
Effective DateDecember 10, 2009
FDA Product Classification
INGREDIENTS (6)
COW MILKActive
Quantity: 0.1 g in 1 mL
Code: 917J3173FT
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
Goats Milk
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code36987-1182
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
Goats Milk
Product Specifications
Route of AdministrationINTRADERMAL, SUBCUTANEOUS
Effective DateDecember 10, 2009
FDA Product Classification
INGREDIENTS (5)
GOAT MILKActive
Quantity: 0.05 g in 1 mL
Code: XE5K5I4RP7
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Cows Milk
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code36987-1180
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
Cows Milk
Product Specifications
Route of AdministrationINTRADERMAL, SUBCUTANEOUS
Effective DateDecember 10, 2009
FDA Product Classification
INGREDIENTS (5)
COW MILKActive
Quantity: 0.1 g in 1 mL
Code: 917J3173FT
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Cows Milk
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code36987-1178
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
Cows Milk
Product Specifications
Route of AdministrationINTRADERMAL, SUBCUTANEOUS
Effective DateDecember 10, 2009
FDA Product Classification
INGREDIENTS (5)
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
COW MILKActive
Quantity: 0.05 g in 1 mL
Code: 917J3173FT
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Casein
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code36987-1177
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
Casein
Product Specifications
Route of AdministrationINTRADERMAL, SUBCUTANEOUS
Effective DateDecember 10, 2009
FDA Product Classification
INGREDIENTS (6)
CASEINActive
Quantity: 0.1 g in 1 mL
Code: 48268V50D5
Classification: ACTIB
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
Cows Milk
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code36987-1179
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
Cows Milk
Product Specifications
Route of AdministrationINTRADERMAL, SUBCUTANEOUS
Effective DateDecember 10, 2009
FDA Product Classification
INGREDIENTS (6)
COW MILKActive
Quantity: 0.05 g in 1 mL
Code: 917J3173FT
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT