Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Antigen Laboratories, Inc.
030705628
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Antigen Laboratories, Inc.
Antigen Laboratories, Inc.
Antigen Laboratories, Inc.
030705628
Products3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Cottonseed
Product Details
NDC Product Code
49288-0116Application Number
BLA102223Marketing Category
BLA (C73585)Route of Administration
INTRADERMAL, SUBCUTANEOUSEffective Date
November 12, 2009Cotton seedActive
Code: DI0ZRJ0MXNClass: ACTIBQuantity: 0.05 g in 1 mL
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACTQuantity: 0.0095 g in 1 mL
SODIUM BICARBONATEInactive
Code: 8MDF5V39QOClass: IACTQuantity: 0.0024 g in 1 mL
GLYCERINInactive
Code: PDC6A3C0OXClass: IACTQuantity: 0.525 mL in 1 mL
WATERInactive
Code: 059QF0KO0RClass: IACT
Coffee
Product Details
NDC Product Code
49288-0100Application Number
BLA102223Marketing Category
BLA (C73585)Route of Administration
INTRADERMAL, SUBCUTANEOUSEffective Date
November 12, 2009Arabica coffee beanActive
Code: 3SW678MX72Class: ACTIBQuantity: 0.05 g in 1 mL
SODIUM BICARBONATEInactive
Code: 8MDF5V39QOClass: IACTQuantity: 0.0024 g in 1 mL
GLYCERINInactive
Code: PDC6A3C0OXClass: IACTQuantity: 0.525 mL in 1 mL
WATERInactive
Code: 059QF0KO0RClass: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACTQuantity: 0.0095 g in 1 mL
Flaxseed
Product Details
NDC Product Code
49288-0201Application Number
BLA102223Marketing Category
BLA (C73585)Route of Administration
INTRADERMAL, SUBCUTANEOUSEffective Date
November 12, 2009Flax seedActive
Code: 4110YT348CClass: ACTIBQuantity: 0.05 g in 1 mL
GLYCERINInactive
Code: PDC6A3C0OXClass: IACTQuantity: 0.525 mL in 1 mL
SODIUM BICARBONATEInactive
Code: 8MDF5V39QOClass: IACTQuantity: 0.0024 g in 1 mL
WATERInactive
Code: 059QF0KO0RClass: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACTQuantity: 0.0095 g in 1 mL