MedPath
FDA Approval

Western Black Willow

November 19, 2009

HUMAN PRESCRIPTION DRUG LABEL

Acer negundo pollen(0.1 g in 1 mL)

Registrants (1)

Antigen Laboratories, Inc.

030705628

Manufacturing Establishments (1)

Antigen Laboratories, Inc.

Antigen Laboratories, Inc.

Antigen Laboratories, Inc.

030705628

Products (136)

Box Elder

49288-0059

BLA102223

BLA (C73585)

SUBCUTANEOUS, INTRADERMAL

November 19, 2009

GLYCERINInactive
Code: PDC6A3C0OXClass: IACTQuantity: 0.525 mL in 1 mL
Code: P6K070AR8VClass: ACTIBQuantity: 0.1 g 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

Smooth (Tag) Alder

49288-0015

BLA102223

BLA (C73585)

SUBCUTANEOUS, INTRADERMAL

November 19, 2009

Code: 605T96G8Y5Class: 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

Spring (Water) Birch

49288-0058

BLA102223

BLA (C73585)

SUBCUTANEOUS, INTRADERMAL

November 19, 2009

GLYCERINInactive
Code: PDC6A3C0OXClass: IACTQuantity: 0.525 mL in 1 mL
Code: R889N2L976Class: 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

Acacia Pollen

49288-0014

BLA102223

BLA (C73585)

SUBCUTANEOUS, INTRADERMAL

November 19, 2009

GLYCERINInactive
Code: PDC6A3C0OXClass: IACTQuantity: 0.525 mL in 1 mL
Code: 59WAV8G5X5Class: ACTIBQuantity: 0.05 g 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

Melaleuca

49288-0317

BLA102223

BLA (C73585)

SUBCUTANEOUS, INTRADERMAL

November 19, 2009

Code: NX974IRT8EClass: 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

Hard (Sugar) Maple

49288-0321

BLA102223

BLA (C73585)

SUBCUTANEOUS, INTRADERMAL

November 19, 2009

GLYCERINInactive
Code: PDC6A3C0OXClass: IACTQuantity: 0.525 mL in 1 mL
Code: V38QUQ7861Class: 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

Soft (Silver) Maple

49288-0323

BLA102223

BLA (C73585)

SUBCUTANEOUS, INTRADERMAL

November 19, 2009

Code: 95447163DGClass: ACTIBQuantity: 0.05 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
SODIUM BICARBONATEInactive
Code: 8MDF5V39QOClass: IACTQuantity: 0.0024 g in 1 mL

Utah Juniper

49288-0274

BLA102223

BLA (C73585)

SUBCUTANEOUS, INTRADERMAL

November 19, 2009

Code: 15L060HV8HClass: 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

California (Coastal) Live Oak

49288-0337

BLA102223

BLA (C73585)

SUBCUTANEOUS, INTRADERMAL

November 19, 2009

SODIUM BICARBONATEInactive
Code: 8MDF5V39QOClass: IACTQuantity: 0.0024 g in 1 mL
Code: VOT5MA71M7Class: 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

Red Maple

49288-0322

BLA102223

BLA (C73585)

SUBCUTANEOUS, INTRADERMAL

November 19, 2009

Code: 700NK45C76Class: 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
Showing 1 to 10 of 136 products
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