Sterile Diluent for Allergenic Extract
Allergenic Extract
Approved
Approval ID
026d3185-aa37-42f8-95a0-7243e0947b7a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 8, 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.
Glycerine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code49288-9935
Application NumberBLA102223
Product Classification
M
Marketing Category
C73585
G
Generic Name
Glycerine
Product Specifications
Route of AdministrationINTRADERMAL, SUBCUTANEOUS
Effective DateDecember 8, 2009
FDA Product Classification
INGREDIENTS (4)
SODIUM CHLORIDEInactive
Quantity: 0.00166 g in 1 mL
Code: 451W47IQ8X
Classification: IACT
GLYCERINActive
Quantity: 0.5 mL in 1 mL
Code: PDC6A3C0OX
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM BICARBONATEInactive
Quantity: 0.00091 g in 1 mL
Code: 8MDF5V39QO
Classification: IACT
Phenol
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code49288-9933
Application NumberBLA102223
Product Classification
M
Marketing Category
C73585
G
Generic Name
Phenol
Product Specifications
Route of AdministrationINTRADERMAL, SUBCUTANEOUS
Effective DateDecember 8, 2009
FDA Product Classification
INGREDIENTS (3)
PHENOLActive
Quantity: 0.004 mL in 1 mL
Code: 339NCG44TV
Classification: ACTIB
SODIUM CHLORIDEInactive
Quantity: 0.009 g in 1 mL
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Human Albumin and Phenol
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code49288-9934
Application NumberBLA102223
Product Classification
M
Marketing Category
C73585
G
Generic Name
Human Albumin and Phenol
Product Specifications
Route of AdministrationINTRADERMAL, SUBCUTANEOUS
Effective DateDecember 8, 2009
FDA Product Classification
INGREDIENTS (4)
PHENOLActive
Quantity: 0.004 mL in 1 mL
Code: 339NCG44TV
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
ALBUMIN (HUMAN)Active
Quantity: 0.0003 mL in 1 mL
Code: ZIF514RVZR
Classification: ACTIB
SODIUM CHLORIDEInactive
Quantity: 0.009 g in 1 mL
Code: 451W47IQ8X
Classification: IACT
Glycerine and Phenol
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code49288-9936
Application NumberBLA102223
Product Classification
M
Marketing Category
C73585
G
Generic Name
Glycerine and Phenol
Product Specifications
Route of AdministrationINTRADERMAL, SUBCUTANEOUS
Effective DateDecember 8, 2009
FDA Product Classification
INGREDIENTS (6)
SODIUM CHLORIDEInactive
Quantity: 0.005 g in 1 mL
Code: 451W47IQ8X
Classification: IACT
GLYCERINActive
Quantity: 0.25 mL in 1 mL
Code: PDC6A3C0OX
Classification: ACTIB
PHENOLActive
Quantity: 0.004 mL in 1 mL
Code: 339NCG44TV
Classification: ACTIB
POTASSIUM PHOSPHATEInactive
Quantity: 0.000567 g in 1 mL
Code: B7862WZ632
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM CITRATEInactive
Quantity: 0.00075 g in 1 mL
Code: 1Q73Q2JULR
Classification: IACT
Glycerine and Phenol
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code49288-9932
Application NumberBLA102223
Product Classification
M
Marketing Category
C73585
G
Generic Name
Glycerine and Phenol
Product Specifications
Route of AdministrationINTRADERMAL, SUBCUTANEOUS
Effective DateDecember 8, 2009
FDA Product Classification
INGREDIENTS (4)
GLYCERINActive
Quantity: 0.1 mL in 1 mL
Code: PDC6A3C0OX
Classification: ACTIB
PHENOLActive
Quantity: 0.004 mL in 1 mL
Code: 339NCG44TV
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM CHLORIDEInactive
Quantity: 0.0009 g in 1 mL
Code: 451W47IQ8X
Classification: IACT