MedPath
FDA Approval

Carob

November 17, 2009

HUMAN PRESCRIPTION DRUG LABEL

Carob(0.05 g in 1 mL)

Registrants (1)

Antigen Laboratories, Inc.

030705628

Manufacturing Establishments (1)

Antigen Laboratories, Inc.

Antigen Laboratories, Inc.

Antigen Laboratories, Inc.

030705628

Products (5)

Carob

49288-0109

BLA102223

BLA (C73585)

SUBCUTANEOUS, INTRADERMAL

November 17, 2009

CarobActive
Code: 5MG5Z946UOClass: ACTIBQuantity: 0.05 g in 1 mL
SODIUM BICARBONATEInactive
Code: 8MDF5V39QOClass: IACTQuantity: 0.0024 g in 1 mL
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACTQuantity: 0.0095 g in 1 mL
GLYCERINInactive
Code: PDC6A3C0OXClass: IACTQuantity: 0.525 mL in 1 mL
WATERInactive
Code: 059QF0KO0RClass: IACT

Tea

49288-0567

BLA102223

BLA (C73585)

INTRADERMAL, SUBCUTANEOUS

November 17, 2009

GLYCERINInactive
Code: PDC6A3C0OXClass: IACTQuantity: 0.525 mL in 1 mL
Tea leafActive
Code: GH42T47V24Class: 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

Cayenne Pepper

49288-0426

BLA102223

BLA (C73585)

SUBCUTANEOUS, INTRADERMAL

November 17, 2009

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
Code: 00UK7646FGClass: ACTIBQuantity: 0.05 g in 1 mL

Currant

49288-0151

BLA102223

BLA (C73585)

SUBCUTANEOUS, INTRADERMAL

November 17, 2009

Code: Q5YG47WU3DClass: 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

Sugar Cane

49288-0482

BLA102223

BLA (C73585)

SUBCUTANEOUS, INTRADERMAL

November 17, 2009

SugarcaneActive
Code: 81H2R5AOH3Class: 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
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