Registrants (1)

Antigen Laboratories, Inc.

DUNS Number

030705628

Manufacturing Establishments (1)

Antigen Laboratories, Inc.

Labeler

Antigen Laboratories, Inc.

Registrant

Antigen Laboratories, Inc.

DUNS Number

030705628

Products (129)

Phycomyces

NDC Product Code

49288-0373

Application Number

BLA102223

Marketing Category

BLA (C73585)

Route of Administration

SUBCUTANEOUS, INTRADERMAL

Effective Date

November 17, 2009

Ingredients

Phycomyces blakesleeanusActive

Code: 41Y752Y34MClass: 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

SODIUM CHLORIDEInactive

Code: 451W47IQ8XClass: IACTQuantity: 0.0095 g in 1 mL

WATERInactive

Code: 059QF0KO0RClass: IACT

Penicillium notatum

NDC Product Code

49288-0416

Application Number

BLA102223

Marketing Category

BLA (C73585)

Route of Administration

SUBCUTANEOUS, INTRADERMAL

Effective Date

November 17, 2009

Ingredients

Penicillium chrysogenum var. chrysogenumActive

Code: 3Y1PE1GCIGClass: ACTIBQuantity: 0.1 g in 1 mL

GLYCERINInactive

Code: PDC6A3C0OXClass: IACTQuantity: 0.525 mL 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

WATERInactive

Code: 059QF0KO0RClass: IACT

C Mold Mixture

NDC Product Code

49288-0091

Application Number

BLA102223

Marketing Category

BLA (C73585)

Route of Administration

INTRADERMAL, SUBCUTANEOUS

Effective Date

November 17, 2009

Ingredients

Verticillium albo-atrumActive

Code: X92O101CS2Class: ACTIBQuantity: 0.0042 g in 1 mL

Mycocladus corymbiferusActive

Code: 1M4E76V32IClass: ACTIBQuantity: 0.0042 g in 1 mL

Humicola griseaActive

Code: RZ55S3AQOJClass: ACTIBQuantity: 0.0042 g in 1 mL

Acrothecium robustumActive

Code: C91ZMT66YAClass: ACTIBQuantity: 0.0042 g in 1 mL

Microsporum audouiniiActive

Code: B7B86Y84R8Class: ACTIBQuantity: 0.0042 g in 1 mL

Microsporum canisActive

Code: N4F4RQ7BY7Class: ACTIBQuantity: 0.0042 g in 1 mL

Stachybotrys chartarumActive

Code: HJ4L70T1ZPClass: ACTIBQuantity: 0.0042 g in 1 mL

GLYCERINInactive

Code: PDC6A3C0OXClass: IACTQuantity: 0.525 mL in 1 mL

Apiospora montagneiActive

Code: 49VI1ZSO06Class: ACTIBQuantity: 0.0042 g in 1 mL

Sporotrichum pruinosumActive

Code: H20KU95UBGClass: ACTIBQuantity: 0.0042 g in 1 mL

Tetracoccosporium paxianumActive

Code: KSY1AWN59IClass: ACTIBQuantity: 0.0042 g in 1 mL

Phycomyces blakesleeanusActive

Code: 41Y752Y34MClass: ACTIBQuantity: 0.0042 g in 1 mL

Syncephalastrum racemosumActive

Code: 2VWV12V9WRClass: ACTIBQuantity: 0.0042 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

WATERInactive

Code: 059QF0KO0RClass: IACT

C Mold Mixture

NDC Product Code

49288-0092

Application Number

BLA102223

Marketing Category

BLA (C73585)

Route of Administration

INTRADERMAL, SUBCUTANEOUS

Effective Date

November 17, 2009

Ingredients

Apiospora montagneiActive

Code: 49VI1ZSO06Class: ACTIBQuantity: 0.0021 g in 1 mL

Mycocladus corymbiferusActive

Code: 1M4E76V32IClass: ACTIBQuantity: 0.0021 g in 1 mL

Acrothecium robustumActive

Code: C91ZMT66YAClass: ACTIBQuantity: 0.0021 g in 1 mL

Humicola griseaActive

Code: RZ55S3AQOJClass: ACTIBQuantity: 0.0021 g in 1 mL

Microsporum audouiniiActive

Code: B7B86Y84R8Class: ACTIBQuantity: 0.0021 g in 1 mL

Microsporum canisActive

Code: N4F4RQ7BY7Class: ACTIBQuantity: 0.0021 g in 1 mL

Phycomyces blakesleeanusActive

Code: 41Y752Y34MClass: ACTIBQuantity: 0.0021 g in 1 mL

Sporotrichum pruinosumActive

Code: H20KU95UBGClass: ACTIBQuantity: 0.0021 g in 1 mL

Stachybotrys chartarumActive

Code: HJ4L70T1ZPClass: ACTIBQuantity: 0.0021 g in 1 mL

Syncephalastrum racemosumActive

Code: 2VWV12V9WRClass: ACTIBQuantity: 0.0021 g in 1 mL

Tetracoccosporium paxianumActive

Code: KSY1AWN59IClass: ACTIBQuantity: 0.0021 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

Verticillium albo-atrumActive

Code: X92O101CS2Class: ACTIBQuantity: 0.0021 g in 1 mL

GLYCERINInactive

Code: PDC6A3C0OXClass: IACTQuantity: 0.525 mL in 1 mL

WATERInactive

Code: 059QF0KO0RClass: IACT

C Mold Mixture

NDC Product Code

49288-0090

Application Number

BLA102223

Marketing Category

BLA (C73585)

Route of Administration

INTRADERMAL, SUBCUTANEOUS

Effective Date

November 17, 2009

Ingredients

Microsporum canisActive

Code: N4F4RQ7BY7Class: ACTIBQuantity: 0.0083 g in 1 mL

Apiospora montagneiActive

Code: 49VI1ZSO06Class: ACTIBQuantity: 0.0083 g in 1 mL

Acrothecium robustumActive

Code: C91ZMT66YAClass: ACTIBQuantity: 0.0083 g in 1 mL

Stachybotrys chartarumActive

Code: HJ4L70T1ZPClass: ACTIBQuantity: 0.0083 g in 1 mL

Mycocladus corymbiferusActive

Code: 1M4E76V32IClass: ACTIBQuantity: 0.0083 g in 1 mL

Humicola griseaActive

Code: RZ55S3AQOJClass: ACTIBQuantity: 0.0083 g in 1 mL

Microsporum audouiniiActive

Code: B7B86Y84R8Class: ACTIBQuantity: 0.0083 g in 1 mL

Tetracoccosporium paxianumActive

Code: KSY1AWN59IClass: ACTIBQuantity: 0.0083 g in 1 mL

Phycomyces blakesleeanusActive

Code: 41Y752Y34MClass: ACTIBQuantity: 0.0083 g in 1 mL

Sporotrichum pruinosumActive

Code: H20KU95UBGClass: ACTIBQuantity: 0.0083 g in 1 mL

Syncephalastrum racemosumActive

Code: 2VWV12V9WRClass: ACTIBQuantity: 0.0083 g in 1 mL

Verticillium albo-atrumActive

Code: X92O101CS2Class: ACTIBQuantity: 0.0083 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

SODIUM CHLORIDEInactive

Code: 451W47IQ8XClass: IACTQuantity: 0.0095 g in 1 mL

WATERInactive

Code: 059QF0KO0RClass: IACT

Humicola grisea

NDC Product Code

49288-0635

Application Number

BLA102223

Marketing Category

BLA (C73585)

Route of Administration

INTRADERMAL, SUBCUTANEOUS

Effective Date

November 17, 2009

Ingredients

SODIUM CHLORIDEInactive

Code: 451W47IQ8XClass: IACTQuantity: 0.0095 g in 1 mL

Humicola griseaActive

Code: RZ55S3AQOJClass: ACTIBQuantity: 0.05 g in 1 mL

GLYCERINInactive

Code: PDC6A3C0OXClass: IACTQuantity: 0.525 mL in 1 mL

WATERInactive

Code: 059QF0KO0RClass: IACT

SODIUM BICARBONATEInactive

Code: 8MDF5V39QOClass: IACTQuantity: 0.0024 g in 1 mL

Neurospora intermedia

NDC Product Code

49288-0326

Application Number

BLA102223

Marketing Category

BLA (C73585)

Route of Administration

SUBCUTANEOUS, INTRADERMAL

Effective Date

November 17, 2009

Ingredients

GLYCERINInactive

Code: PDC6A3C0OXClass: IACTQuantity: 0.525 mL in 1 mL

Neurospora intermediaActive

Code: 2072U60DUIClass: ACTIBQuantity: 0.05 g in 1 mL

SODIUM CHLORIDEInactive

Code: 451W47IQ8XClass: IACTQuantity: 0.0095 g in 1 mL

WATERInactive

Code: 059QF0KO0RClass: IACT

SODIUM BICARBONATEInactive

Code: 8MDF5V39QOClass: IACTQuantity: 0.0024 g in 1 mL

Mucor plumbeus

NDC Product Code

49288-0638

Application Number

BLA102223

Marketing Category

BLA (C73585)

Route of Administration

SUBCUTANEOUS, INTRADERMAL

Effective Date

November 17, 2009

Ingredients

GLYCERINInactive

Code: PDC6A3C0OXClass: IACTQuantity: 0.525 mL in 1 mL

Mucor plumbeusActive

Code: D7401PWY6EClass: 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

WATERInactive

Code: 059QF0KO0RClass: IACT

Penicillium camembertii

NDC Product Code

49288-0648

Application Number

BLA102223

Marketing Category

BLA (C73585)

Route of Administration

SUBCUTANEOUS, INTRADERMAL

Effective Date

November 17, 2009

Ingredients

Penicillium camembertiActive

Code: T069R9OPVGClass: ACTIBQuantity: 0.05 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

SODIUM BICARBONATEInactive

Code: 8MDF5V39QOClass: IACTQuantity: 0.0024 g in 1 mL

Penicillium chrysogenum

NDC Product Code

49288-0649

Application Number

BLA102223

Marketing Category

BLA (C73585)

Route of Administration

SUBCUTANEOUS, INTRADERMAL

Effective Date

November 17, 2009

Ingredients

Penicillium chrysogenum var. chrysogenumActive

Code: 3Y1PE1GCIGClass: ACTIBQuantity: 0.05 g in 1 mL

GLYCERINInactive

Code: PDC6A3C0OXClass: IACTQuantity: 0.525 mL 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

WATERInactive

Code: 059QF0KO0RClass: IACT

Showing 1 to 10 of 129 products

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Chaetomium

Registrants (1)

Manufacturing Establishments (1)

Products (129)

Phycomyces

Penicillium notatum

C Mold Mixture

C Mold Mixture

C Mold Mixture

Humicola grisea

Neurospora intermedia

Mucor plumbeus

Penicillium camembertii

Penicillium chrysogenum

Drug Labeling Information

BOXED WARNING SECTION

WARNINGS