MedPath
FDA Approval

Dandelion

December 4, 2009

HUMAN PRESCRIPTION DRUG LABEL

Amaranthus spinosus 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)

Spiny Pigweed

36987-3319

BLA102192

BLA (C73585)

SUBCUTANEOUS, INTRADERMAL

December 4, 2009

Code: 380W4HYR6NClass: ACTIBQuantity: 20000 [PNU] in 1 mL
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QOClass: IACT
PHENOLInactive
Code: 339NCG44TVClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT

Wormwood

36987-3447

BLA102192

BLA (C73585)

SUBCUTANEOUS, INTRADERMAL

December 4, 2009

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

Carelessweed

36987-3159

BLA102192

BLA (C73585)

INTRADERMAL, SUBCUTANEOUS

December 4, 2009

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

Curly Dock

36987-3183

BLA102192

BLA (C73585)

INTRADERMAL, SUBCUTANEOUS

December 4, 2009

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

Wingscale

36987-3439

BLA102192

BLA (C73585)

SUBCUTANEOUS, INTRADERMAL

December 4, 2009

SODIUM BICARBONATEInactive
Code: 8MDF5V39QOClass: IACT
Code: 26U0BU8G83Class: ACTIBQuantity: 20000 [PNU] in 1 mL
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
PHENOLInactive
Code: 339NCG44TVClass: IACT

Russian Thistle

36987-3399

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

Greasewood

36987-3375

BLA102192

BLA (C73585)

SUBCUTANEOUS, INTRADERMAL

December 4, 2009

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

Western Ragweed

36987-3431

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
WATERInactive
Code: 059QF0KO0RClass: IACT
PHENOLInactive
Code: 339NCG44TVClass: IACT

Tall Ragweed

36987-3391

BLA102192

BLA (C73585)

SUBCUTANEOUS, INTRADERMAL

December 4, 2009

SODIUM BICARBONATEInactive
Code: 8MDF5V39QOClass: IACT
PHENOLInactive
Code: 339NCG44TVClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
Code: KU1V1898XXClass: ACTIBQuantity: 20000 [PNU] in 1 mL
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT

Ailanthus

36987-3359

BLA102192

BLA (C73585)

SUBCUTANEOUS, INTRADERMAL

December 4, 2009

PHENOLInactive
Code: 339NCG44TVClass: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QOClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
Code: 2A64U81OQ3Class: ACTIBQuantity: 20000 [PNU] in 1 mL
Showing 1 to 10 of 39 products
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