MedPath
FDA Approval

Dandelion

December 4, 2009

HUMAN PRESCRIPTION DRUG LABEL

Amaranthus palmeri pollen(20000 [PNU] in 1 mL)

Registrants (1)

Nelco Laboratories, Inc.

054980867

Manufacturing Establishments (1)

Nelco Laboratories, Inc.

Nelco Laboratories, Inc.

Nelco Laboratories, Inc.

054980867

Products (39)

Carelessweed

36987-3160

BLA102192

BLA (C73585)

INTRADERMAL, SUBCUTANEOUS

December 4, 2009

Code: 1GH3WV23KHClass: ACTIBQuantity: 20000 [PNU] in 1 mL
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
PHENOLInactive
Code: 339NCG44TVClass: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QOClass: IACT
GLYCERINInactive
Code: PDC6A3C0OXClass: IACT

Wormwood

36987-3448

BLA102192

BLA (C73585)

SUBCUTANEOUS, INTRADERMAL

December 4, 2009

Code: 81GS97HVFOClass: ACTIBQuantity: 20000 [PNU] in 1 mL
PHENOLInactive
Code: 339NCG44TVClass: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QOClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
GLYCERINInactive
Code: PDC6A3C0OXClass: IACT

Curly Dock

36987-3184

BLA102192

BLA (C73585)

INTRADERMAL, SUBCUTANEOUS

December 4, 2009

Code: V825XJG64GClass: ACTIBQuantity: 20000 [PNU] in 1 mL
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
PHENOLInactive
Code: 339NCG44TVClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
GLYCERINInactive
Code: PDC6A3C0OXClass: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QOClass: IACT

Hackberry

36987-3352

BLA102192

BLA (C73585)

SUBCUTANEOUS, INTRADERMAL

December 4, 2009

Code: 68R9X9Y96XClass: ACTIBQuantity: 20000 [PNU] in 1 mL
SODIUM BICARBONATEInactive
Code: 8MDF5V39QOClass: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
PHENOLInactive
Code: 339NCG44TVClass: IACT
GLYCERINInactive
Code: PDC6A3C0OXClass: IACT

Russian Thistle

36987-3400

BLA102192

BLA (C73585)

SUBCUTANEOUS, INTRADERMAL

December 4, 2009

Code: 2MH135KC6GClass: ACTIBQuantity: 20000 [PNU] in 1 mL
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QOClass: IACT
PHENOLInactive
Code: 339NCG44TVClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
GLYCERINInactive
Code: PDC6A3C0OXClass: IACT

Ailanthus

36987-3360

BLA102192

BLA (C73585)

SUBCUTANEOUS, INTRADERMAL

December 4, 2009

SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QOClass: IACT
Code: 2A64U81OQ3Class: ACTIBQuantity: 20000 [PNU] in 1 mL
PHENOLInactive
Code: 339NCG44TVClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
GLYCERINInactive
Code: PDC6A3C0OXClass: IACT

False Ragweed

36987-3368

BLA102192

BLA (C73585)

SUBCUTANEOUS, INTRADERMAL

December 4, 2009

Code: U2AI3H2J5YClass: ACTIBQuantity: 20000 [PNU] in 1 mL
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QOClass: IACT
GLYCERINInactive
Code: PDC6A3C0OXClass: IACT
PHENOLInactive
Code: 339NCG44TVClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT

Greasewood

36987-3376

BLA102192

BLA (C73585)

SUBCUTANEOUS, INTRADERMAL

December 4, 2009

Code: 6532U64A3XClass: ACTIBQuantity: 20000 [PNU] in 1 mL
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QOClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
PHENOLInactive
Code: 339NCG44TVClass: IACT
GLYCERINInactive
Code: PDC6A3C0OXClass: IACT

Common Sagebrush

36987-3408

BLA102192

BLA (C73585)

SUBCUTANEOUS, INTRADERMAL

December 4, 2009

SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
PHENOLInactive
Code: 339NCG44TVClass: IACT
Code: YI19RB8YFDClass: ACTIBQuantity: 20000 [PNU] in 1 mL
SODIUM BICARBONATEInactive
Code: 8MDF5V39QOClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
GLYCERINInactive
Code: PDC6A3C0OXClass: IACT

Western Ragweed

36987-3432

BLA102192

BLA (C73585)

SUBCUTANEOUS, INTRADERMAL

December 4, 2009

Code: RX18M46K8LClass: ACTIBQuantity: 20000 [PNU] in 1 mL
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QOClass: IACT
PHENOLInactive
Code: 339NCG44TVClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
GLYCERINInactive
Code: PDC6A3C0OXClass: IACT
Showing 1 to 10 of 39 products
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