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
NDC Product Code36987-1174
Application NumberBLA102192
Marketing CategoryC73585
Route of AdministrationINTRADERMAL, SUBCUTANEOUS
Effective DateDecember 10, 2009
Generic NameCasein
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
NDC Product Code36987-1184
Application NumberBLA102192
Marketing CategoryC73585
Route of AdministrationINTRADERMAL, SUBCUTANEOUS
Effective DateDecember 10, 2009
Generic NameGoats Milk
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
NDC Product Code36987-1185
Application NumberBLA102192
Marketing CategoryC73585
Route of AdministrationINTRADERMAL, SUBCUTANEOUS
Effective DateDecember 10, 2009
Generic NameGoats Milk
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
NDC Product Code36987-1183
Application NumberBLA102192
Marketing CategoryC73585
Route of AdministrationINTRADERMAL, SUBCUTANEOUS
Effective DateDecember 10, 2009
Generic NameGoats Milk
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
NDC Product Code36987-1181
Application NumberBLA102192
Marketing CategoryC73585
Route of AdministrationINTRADERMAL, SUBCUTANEOUS
Effective DateDecember 10, 2009
Generic NameCows Milk
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
NDC Product Code36987-1182
Application NumberBLA102192
Marketing CategoryC73585
Route of AdministrationINTRADERMAL, SUBCUTANEOUS
Effective DateDecember 10, 2009
Generic NameGoats Milk
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
NDC Product Code36987-1180
Application NumberBLA102192
Marketing CategoryC73585
Route of AdministrationINTRADERMAL, SUBCUTANEOUS
Effective DateDecember 10, 2009
Generic NameCows Milk
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
NDC Product Code36987-1178
Application NumberBLA102192
Marketing CategoryC73585
Route of AdministrationINTRADERMAL, SUBCUTANEOUS
Effective DateDecember 10, 2009
Generic NameCows Milk
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
NDC Product Code36987-1177
Application NumberBLA102192
Marketing CategoryC73585
Route of AdministrationINTRADERMAL, SUBCUTANEOUS
Effective DateDecember 10, 2009
Generic NameCasein
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
NDC Product Code36987-1179
Application NumberBLA102192
Marketing CategoryC73585
Route of AdministrationINTRADERMAL, SUBCUTANEOUS
Effective DateDecember 10, 2009
Generic NameCows Milk
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