American Cockroach
Allergenic Extract
Approved
Approval ID
ef112633-e979-4933-b34b-e4d5756a90dc
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 13, 2009
Manufacturers
FDA
Antigen Laboratories, Inc.
DUNS: 030705628
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
American Cockroach
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code49288-0149
Application NumberBLA102223
Product Classification
M
Marketing Category
C73585
G
Generic Name
American Cockroach
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
GLYCERINInactive
Quantity: 0.525 mL in 1 mL
Code: PDC6A3C0OX
Classification: IACT
PERIPLANETA AMERICANAActive
Quantity: 0.05 g in 1 mL
Code: 2RQ1L9N089
Classification: ACTIB
SODIUM BICARBONATEInactive
Quantity: 0.0024 g in 1 mL
Code: 8MDF5V39QO
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
American Cockroach
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code49288-0150
Application NumberBLA102223
Product Classification
M
Marketing Category
C73585
G
Generic Name
American Cockroach
Product Specifications
Route of AdministrationSUBCUTANEOUS, INTRADERMAL
Effective DateNovember 13, 2009
FDA Product Classification
INGREDIENTS (5)
PERIPLANETA AMERICANAActive
Quantity: 0.02 g in 1 mL
Code: 2RQ1L9N089
Classification: ACTIB
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
SODIUM BICARBONATEInactive
Quantity: 0.0024 g in 1 mL
Code: 8MDF5V39QO
Classification: IACT
American Cockroach
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code49288-0148
Application NumberBLA102223
Product Classification
M
Marketing Category
C73585
G
Generic Name
American Cockroach
Product Specifications
Route of AdministrationSUBCUTANEOUS, INTRADERMAL
Effective DateNovember 13, 2009
FDA Product Classification
INGREDIENTS (5)
PERIPLANETA AMERICANAActive
Quantity: 0.1 g in 1 mL
Code: 2RQ1L9N089
Classification: ACTIB
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
SODIUM BICARBONATEInactive
Quantity: 0.0024 g in 1 mL
Code: 8MDF5V39QO
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT